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respecto a placebo durante 48 semanas en ni&#241;os mayores de 12 a&#241;os y adultos &#40;STRIVE&#41;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">7</span></a> y en ni&#241;os de 6 a 11 a&#241;os &#40;ENVISION&#41;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">8</span></a>&#46; En ambos estudios&#44; el grupo tratado con ivacaftor experiment&#243; mejoras significativas en el FEV<span class="elsevierStyleInf">1</span>&#44; la concentraci&#243;n de cloro en sudor y el peso corporal&#46; Un estudio de extensi&#243;n posterior &#40;PERSIST&#41; con seguimiento de pacientes tratados con ivacaftor durante 96 semanas adicionales confirm&#243; la mejor&#237;a cl&#237;nica y no encontr&#243; efectos adversos significativos<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">9</span></a>&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">No obstante&#44; estos estudios ten&#237;an las limitaciones caracter&#237;sticas de los ensayos cl&#237;nicos&#46; Se excluy&#243; a pacientes con enfermedades o aislamiento de microorganismos que pudieran actuar como factores de confusi&#243;n&#44; a pacientes con exacerbaciones o cambios de tratamiento en las semanas precedentes&#44; y a pacientes previamente tratados con f&#225;rmacos inhibidores o inductores del citocromo P450 3<span class="elsevierStyleHsp" style=""></span>A&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">El objetivo del presente estudio fue analizar la evoluci&#243;n de ni&#241;os tratados con ivacaftor 2&#44;5 a&#241;os despu&#233;s de su comercializaci&#243;n en el Reino Unido&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">M&#233;todos</span><p id="par0025" class="elsevierStylePara elsevierViewall">El estudio se realiz&#243; en el Royal London Hospital&#44; un centro de referencia para la FQ en el este de Londres que maneja m&#225;s de 100 ni&#241;os con FQ&#46; Durante el seguimiento&#44; se recogieron datos sobre medidas antropom&#233;tricas&#44; la dosis de enzimas pancre&#225;ticas&#44; los ciclos de antibi&#243;ticos&#44; la frecuencia del aislamiento de microorganismos y la funci&#243;n pulmonar&#44; as&#237; como muestras cl&#237;nicas &#40;esputo&#44; frotis far&#237;ngeo&#41;&#46; En los pacientes tratados con ivacaftor tambi&#233;n se realizaron determinaciones seriadas de transaminasas y cloro en sudor antes de iniciarse el tratamiento y a las 6 semanas&#44; 6 meses&#44; un a&#241;o y 2 a&#241;os de tratamiento&#46; Para calcular los valores de referencia sobre el predicho del FEV<span class="elsevierStyleInf">1</span> &#40;FEV1&#37;&#41;&#44; la capacidad vital forzada &#40;FVC&#37;&#41; y los mesoflujos &#40;FEF<span class="elsevierStyleInf">25&#37;-75&#37;</span>&#41; se utilizaron las ecuaciones propuestas por la Global Lung Function Initiative&#46; El z-score del peso&#44; talla e IMC se calcul&#243; con las tablas publicadas por la Organizaci&#243;n Mundial de la Salud&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Se incluyeron todos los pacientes menores de 17 a&#241;os con una o m&#225;s mutaciones G551D tratados con ivacaftor entre enero de 2013 y junio de 2015&#44; independientemente de la duraci&#243;n del tratamiento&#46; La dosis administrada fue de 150<span class="elsevierStyleHsp" style=""></span>mg&#47;12<span class="elsevierStyleHsp" style=""></span>h una vez al d&#237;a&#44; o dos veces por semana en caso de tratamiento concomitante con f&#225;rmacos inhibidores de citocromo P450 3<span class="elsevierStyleHsp" style=""></span>A&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Se incluyeron todos los datos recogidos durante el tratamiento con ivacaftor y los del a&#241;o previo cuando estaban disponibles&#46; El an&#225;lisis se bas&#243; en los valores basales y los &#250;ltimos valores obtenidos durante el tratamiento con ivacaftor&#46; Tambi&#233;n se calcularon los valores medios de los datos recogidos durante el tratamiento&#44; agrupados en intervalos de 6 meses&#46; Las comparaciones se realizaron con el valor basal &#40;definido como el valor registrado m&#225;s recientemente antes de administrarse la primera dosis de ivacaftor&#41; o el primer valor disponible&#44; as&#237; como con el valor medio del a&#241;o previo al inicio del tratamiento&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">El an&#225;lisis estad&#237;stico se realiz&#243; con el software SPSS 19&#46;0&#46; El nivel de significaci&#243;n estad&#237;stica se estableci&#243; en p &#60;<span class="elsevierStyleHsp" style=""></span>0&#44;05&#46; La media y desviaci&#243;n est&#225;ndar &#40;DE&#41; de los datos agrupados a intervalos de 6 meses y la de los obtenidos el a&#241;o previo al tratamiento se compararon mediante an&#225;lisis de varianza&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Resultados</span><p id="par0045" class="elsevierStylePara elsevierViewall">Se incluyeron 4 pacientes de 6 a 14 a&#241;os de edad que hab&#237;an recibido ivacaftor durante una media de 24 meses &#40;12 meses&#44; 24 meses&#44; 30 meses&#44; 30 meses&#41;&#46; Todos eran heterocigotos F508del&#47;G551D y ten&#237;an insuficiencia pancre&#225;tica &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">tabla 1</a>&#41;&#46; En dos pacientes se inici&#243; tratamiento con ivacaftor cuando fue autorizado en el Reino Unido en enero de 2013&#59; el paciente 3 tuvo que esperar hasta que cumpli&#243; los 6 a&#241;os en mayo de 2013&#46; El estado cl&#237;nico de los pacientes al inicio de ivacaftor era muy variado&#46; El paciente 1 hab&#237;a sido diagnosticado de aspergilosis broncopulmonar al&#233;rgica &#40;ABPA&#41; con varias reca&#237;das en los 5 a&#241;os anteriores&#44; as&#237; como en los primeros meses de tratamiento con ivacaftor&#44; que se trataron repetidamente con prednisolona junto con itraconazol o voriconazol&#46; Este paciente hab&#237;a tambi&#233;n sido diagnosticado de enfermedad pulmonar por <span class="elsevierStyleItalic">M&#46; abscessus</span> 7 meses antes de iniciarse el tratamiento con ivacaftor&#44; con aislamiento recurrente de <span class="elsevierStyleItalic">M&#46; abscessus</span> asociado a deterioro de la funci&#243;n pulmonar y hallazgos patol&#243;gicos en la tomograf&#237;a computarizada &#40;TC&#41;&#46; Hab&#237;a recibido tratamiento de erradicaci&#243;n con antibioterapia intensiva intravenosa&#44; nebulizada y oral conforme a las recomendaciones vigentes&#46; No obstante&#44; el paciente continu&#243; teniendo cultivos positivos a <span class="elsevierStyleItalic">M&#46; abscessus</span> antes de iniciarse el tratamiento con ivacaftor a pesar de la terapia de mantenimiento nebulizada y oral&#46; En los primeros meses&#44; el paciente recibi&#243; dosis reducidas de ivacaftor dos veces por semana debido al tratamiento concomitante con claritromicina y voriconazol&#46; Durante el tratamiento con ivacaftor&#44; se negativizaron los cultivos de <span class="elsevierStyleItalic">M&#46; abscessus</span> y no tuvo m&#225;s episodios de ABPA&#46; A los 6 meses se interrumpi&#243; el tratamiento con claritromicina y voriconazol y el paciente comenz&#243; a recibir la pauta est&#225;ndar de ivacaftor con dosis diarias&#46; A la finalizaci&#243;n del estudio&#44; el paciente llevaba 21 meses sin presentar <span class="elsevierStyleItalic">M&#46; abscessus</span> ni ABPA&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0050" class="elsevierStylePara elsevierViewall">En el caso de la paciente 3&#44; no se dispuso de datos fiables de espirometr&#237;a hasta los 6 meses de tratamiento con ivacaftor&#46; La paciente 4 se diagnostic&#243; de fibrosis qu&#237;stica a los 13 a&#241;os y comenz&#243; tratamiento con ivacaftor junto con el inicio de la terapia multidisciplinar de la enfermedad y un ciclo de antibioterapia intravenosa&#46; En la actualidad los 4 pacientes contin&#250;an recibiendo tratamiento con ivacaftor&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">La funci&#243;n pulmonar &#8212;y especialmente el FEV<span class="elsevierStyleInf">1</span> y los mesoflujos&#8212; mejor&#243; en los 4 pacientes&#44; y esta mejora se mantuvo durante todo el seguimiento &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">tabla 2</a>&#41;&#46; Los valores basales de FEV<span class="elsevierStyleInf">1</span>&#37; oscilaron entre el 58&#44;5 y el 81&#44;8&#37;&#46; Al comparar los &#250;ltimos valores registrados durante el tratamiento con los valores basales &#40;en el caso del paciente 3&#44; el primer valor fiable&#41;&#44; se observ&#243; una mejor&#237;a global del FEV<span class="elsevierStyleInf">1</span>&#37; de 25&#44;72 puntos porcentuales&#46; Cuando comparamos los valores finales con los valores medios del a&#241;o anterior a iniciar el tratamiento en los pacientes 1 y 2&#44; observamos una mejor&#237;a global del FEV<span class="elsevierStyleInf">1</span>&#37; de 18&#44;85 puntos porcentuales&#46; Cuando se incluyeron en el an&#225;lisis todos los valores de la funci&#243;n pulmonar obtenidos durante el tratamiento&#44; la mejor&#237;a global en el FEV<span class="elsevierStyleInf">1</span>&#37; fue de 11&#44;96 puntos porcentuales respecto al valor basal&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0060" class="elsevierStylePara elsevierViewall">La mejor&#237;a global de los mesoflujos al final del seguimiento fue de 46&#44;65 puntos porcentuales respecto a los valores basales&#46; La FVC&#37; mejor&#243; en 3 de los pacientes durante el tratamiento&#44; mientras que el cociente FEV1&#47;FVC mejor&#243; significativamente en uno&#46; La mejor&#237;a global de la FVC&#37; al final del seguimiento fue de 12&#44;75 puntos porcentuales con respecto al valor basal&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">El estado nutricional&#44; evaluado mediante el z-score del IMC&#44; mejor&#243; progresivamente en todos los pacientes durante el tratamiento con ivacaftor &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">tabla 3</a>&#41;&#46; La mejor&#237;a absoluta de la puntuaci&#243;n z-score en la &#250;ltima evaluaci&#243;n antropom&#233;trica durante el tratamiento en comparaci&#243;n con los valores basales fue de 1&#44;6 puntos&#46; Cuando agrupamos los valores de los pacientes 1&#44; 2 y 3 al final del seguimiento y los comparamos con los valores del a&#241;o previo al inicio del tratamiento&#44; observamos un aumento de 0&#44;50 puntos en el z-score medio&#46; Cuando se incluyeron todos los valores registrados en los pacientes 1-3 durante el tratamiento&#44; encontramos una mejor&#237;a similar en el z-score &#40;1&#44;37 puntos con respecto al valor basal&#44; y 0&#44;54 con respecto al a&#241;o previo&#41;&#46;</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><p id="par0070" class="elsevierStylePara elsevierViewall">Tambi&#233;n se observaron mejor&#237;as en el peso corporal que se mantuvieron constantes durante el seguimiento&#46; El z-score del peso al final del seguimiento mejor&#243; 1&#44;53 puntos respecto al basal y 0&#44;50 puntos respecto al a&#241;o previo al tratamiento en los pacientes 1-3&#46; La mejor&#237;a en el z-score de la talla fue mucho m&#225;s modesta&#44; con un aumento al final del seguimiento de 0&#44;41 puntos respecto al basal&#44; y de 0&#44;01 puntos con respecto al a&#241;o previo en los pacientes 1-3&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">La dosis de lipasa por kilogramo de peso corporal se redujo significativamente y de manera gradual en los 4 pacientes &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">tabla 3</a>&#41;&#46; Cuando analizamos conjuntamente las dosis de los pacientes 1-3&#44; encontramos una reducci&#243;n del 39&#44;5&#37; al final del seguimiento en comparaci&#243;n con el momento inicial&#46; Asimismo&#44; la dosis total de enzimas pancre&#225;ticas se redujo en 2 pacientes&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">Antes de iniciarse el tratamiento con ivacaftor&#44; la concentraci&#243;n de cloro en sudor era &#8805; 90 mEq&#47;l en todos los pacientes&#46; Este valor hab&#237;a disminuido significativamente cuando se hizo el primer control a las 6 semanas&#46; En los 3 pacientes que hab&#237;an sido tratados con ivacaftor durante 2 o m&#225;s a&#241;os&#44; la &#250;ltima determinaci&#243;n revel&#243; valores de menos de 40 mEq&#47;l &#40;<a class="elsevierStyleCrossRef" href="#tbl0020">tabla 4</a>&#41;&#46; La reducci&#243;n media al final del seguimiento fue de &#8211;58 mEq&#47;l&#46;</p><elsevierMultimedia ident="tbl0020"></elsevierMultimedia><p id="par0085" class="elsevierStylePara elsevierViewall">El n&#250;mero de aislamientos de <span class="elsevierStyleItalic">P&#46; aeruginosa</span> de muestras de secreciones respiratorias fue bajo en general&#44; y disminuy&#243; ligeramente con respecto al a&#241;o previo a la iniciaci&#243;n de ivacaftor en los pacientes 1-3 &#40;ninguno tuvo una infecci&#243;n cr&#243;nica&#41;&#46; El n&#250;mero medio de aislamientos de <span class="elsevierStyleItalic">P&#46; aeruginosa</span> fue de 0&#44;67 por paciente&#47;a&#241;o durante el a&#241;o previo al tratamiento &#40;pacientes 1-3&#41; y de 0&#44;27 por paciente&#47;a&#241;o durante el tratamiento&#46; El n&#250;mero de exacerbaciones respiratorias que requirieron antibioterapia tambi&#233;n disminuy&#243; en los pacientes 1-3 con respecto al a&#241;o previo&#44; tanto para la antibioterapia oral &#40;3 vs&#46; 1&#44;7 ciclos por paciente&#47;a&#241;o&#41; como para la intravenosa &#40;uno vs&#46; 0&#44;5 ciclos por paciente&#47;a&#241;o&#41;&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">Se observ&#243; mejor&#237;a radiol&#243;gica en 3 pacientes&#46; En el paciente 1&#44; la TC mostr&#243; una mejor&#237;a significativa&#44; aunque la comparaci&#243;n se realiz&#243; al finalizarse el tratamiento para la infecci&#243;n por <span class="elsevierStyleItalic">M&#46; abscessus</span> y la ABPA&#46; Seg&#250;n el informe del radi&#243;logo&#44; la radiograf&#237;a del paciente 2 mostr&#243; resoluci&#243;n del engrosamiento peribronquial en la base del pulm&#243;n izquierdo en comparaci&#243;n con la radiograf&#237;a previa&#46; La paciente 4 presentaba bronquiectasias significativas al diagn&#243;stico&#44; que mejoraron considerablemente durante el tratamiento&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">El &#250;nico efecto adverso que se observ&#243; en el estudio fue una elevaci&#243;n leve y transitoria en los niveles s&#233;ricos de transaminasas en el paciente 1 &#40;AST&#44; 43 UI&#47;ml&#59; ALT&#44; 42 UI&#47;ml&#41;&#46; No se observaron problemas de adherencia&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Discusi&#243;n</span><p id="par0100" class="elsevierStylePara elsevierViewall">En este estudio de la evoluci&#243;n en vida real de 4 pacientes con FQ y genotipo F508del&#47;G551D&#44; el uso de ivacaftor se asoci&#243; a mejor&#237;as en la funci&#243;n pulmonar&#44; el estado nutricional&#44; la dosis de enzimas pancre&#225;ticas&#44; el cloro en sudor&#44; el n&#250;mero de aislamientos de <span class="elsevierStyleItalic">P&#46; aeruginosa</span> y el uso de antibi&#243;ticos&#46; Aunque estudios previos sobre el uso de ivacaftor ya hab&#237;an reportado mejor&#237;as en muchos de estos par&#225;metros&#44; los estudios con datos en la vida real ofrecen un valor a&#241;adido de efectividad&#46; La practica cl&#237;nica difiere significativamente de los protocolos de ensayos cl&#237;nicos que adem&#225;s excluyen a muchos pacientes por no cumplir los criterios de inclusi&#243;n&#46; As&#237;&#44; 3 de los 4 pacientes en el presente estudio no est&#225;n representados en los ensayos cl&#237;nicos&#46; El paciente 1 fue tratado con inhibidores del citocromo P450 3<span class="elsevierStyleHsp" style=""></span>A durante 9 meses&#44; lo que era motivo de exclusi&#243;n en los ensayos cl&#237;nicos de ivacaftor<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">8</span></a>&#46; En el caso de la paciente 3&#44; de 6 a&#241;os de edad&#44; no se dispuso de datos espirom&#233;tricos fiables hasta los 6 meses de tratamiento&#46; La paciente 4 recibi&#243; un diagn&#243;stico tard&#237;o y comenz&#243; tratamiento con ivacaftor a la vez que iniciaba el tratamiento multidisciplinar de la fibrosis qu&#237;stica&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">En el presente estudio se analizaron todos los datos de la funci&#243;n pulmonar y antropometr&#237;a registrados durante el tratamiento con ivacaftor y tambi&#233;n durante el a&#241;o previo a su iniciaci&#243;n&#46; En los ensayos cl&#237;nicos&#44; el protocolo requiere una evaluaci&#243;n basal de la funci&#243;n pulmonar&#44; cuyos resultados se comparan con los obtenidos tras un per&#237;odo preestablecido&#44; normalmente a intervalos de 8-12 semanas&#46; Sin embargo&#44; los pacientes con FQ experimentan fluctuaciones frecuentes en la funci&#243;n pulmonar y el peso corporal debido a las exacerbaciones respiratorias y complicaciones diversas&#46; En este sentido&#44; consideramos que la inclusi&#243;n de todos los datos recogidos durante el per&#237;odo de estudio a&#241;ade valor en lo concerniente a la efectividad real de ivacaftor&#46; Adem&#225;s&#44; la comparaci&#243;n con valores del a&#241;o previo puede incrementar a&#250;n m&#225;s la precisi&#243;n del an&#225;lisis&#44; ya que es posible que el estado del paciente al inicio del tratamiento no refleje su situaci&#243;n en los meses previos&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">La mejor&#237;a en el FEV<span class="elsevierStyleInf">1</span>&#37; con respecto al valor basal &#40;25&#44;72 puntos porcentuales&#41; fue mayor que la observada en estudios previos &#40;10&#44;6 y 12&#44;5 puntos a las 24 semanas y 10&#44;5 y 10 puntos a las 48 semanas<a class="elsevierStyleCrossRefs" href="#bib0175"><span class="elsevierStyleSup">8&#44;9</span></a>&#41;&#46; Tres de nuestros pacientes ten&#237;an un FEV<span class="elsevierStyleInf">1</span>&#37; basal &#8804;70&#44;3&#37;&#44; mientras que la mayor&#237;a de los pacientes en los estudios ENVISION y PERSIST ten&#237;an valores basales de FEV<span class="elsevierStyleInf">1</span>&#37; &#62; 70&#37;&#46; En el estudio ENVISION los pacientes con mayor gravedad&#44; expresada por un menor cociente FEV<span class="elsevierStyleInf">1</span>&#47;FVC &#40;&#8804; 0&#44;748&#41; o FEV<span class="elsevierStyleInf">1</span>&#37; basal &#40;50-80&#37;&#41;&#44; fueron tambi&#233;n los que mostraron mayor efecto del tratamiento&#44; con una mejor&#237;a del FEV<span class="elsevierStyleInf">1</span>&#37; de alrededor de 20 puntos<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">8</span></a>&#46; Adem&#225;s&#44; el mayor incremento en el FEV<span class="elsevierStyleInf">1</span>&#37; en nuestro estudio se registr&#243; en la paciente 4 &#40;49&#44;5 puntos&#41;&#44; en la que se inici&#243; el programa de manejo multidisciplinar &#40;incluyendo antibioterapia intravenosa&#41; cuando comenz&#243; el tratamiento con ivacaftor&#44; por lo que parte de la mejor&#237;a observada en este caso podr&#237;a deberse al manejo general de la FQ&#46; No obstante&#44; la mejor&#237;a observada en su TC super&#243; las expectativas&#46; Cuando comparamos los resultados de los pacientes 1 y 2 con el valor medio del a&#241;o previo a la iniciaci&#243;n de ivacaftor&#44; encontramos un aumento de 18&#44;85 puntos porcentuales en el FEV<span class="elsevierStyleInf">1</span>&#37;&#44; lo que concuerda m&#225;s con los resultados de los ensayos cl&#237;nicos&#46; La mejor&#237;a obtenida con el ivacaftor podr&#237;a alterar el deterioro progresivo de la funci&#243;n pulmonar caracter&#237;stico de la historia natural de la FQ<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">10</span></a>&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">La mejor&#237;a en los mesoflujos tambi&#233;n fue mayor que la descrita en los ensayos cl&#237;nicos&#44; probablemente por las razones ya mencionadas en relaci&#243;n con el FEV<span class="elsevierStyleInf">1</span>&#44; mientras que la mejor&#237;a en la FVC fue modesta&#46; El incremento en el cociente FEV<span class="elsevierStyleInf">1</span>&#47;FVC observado en el paciente 1 probablemente se debi&#243; a la mejor&#237;a de la obstrucci&#243;n bronquial tras el tratamiento de la ABPA&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">El estado nutricional&#44; evaluado por medio del z-score del IMC&#44; mejor&#243; r&#225;pidamente y de manera sostenida en todos los pacientes durante el tratamiento&#46; La mejor&#237;a global de 1&#44;6 puntos se debe en parte a la mejor&#237;a de 4&#44;7 puntos en la paciente 4&#44; a la que tambi&#233;n contribuy&#243; el manejo multidisciplinar de la FQ y el inicio de la terapia con enzimas pancre&#225;ticas&#59; al excluir a esta paciente del an&#225;lisis&#44; la mejor&#237;a global fue de 0&#44;57 puntos con respecto al z-score basal y de 0&#44;50 puntos con respecto al a&#241;o previo&#46; Estos hallazgos fueron similares a los del estudio ENVISION a las 48 semanas de tratamiento &#40;en comparaci&#243;n con el grupo de control&#41;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">8</span></a>&#46; Los cambios de peso siguieron un patr&#243;n similar al de los cambios del IMC&#46; Sin embargo&#44; el incremento en el z-score de la talla fue muy modesto&#44; aunque es posible que se hubieran registrado diferencias mayores si el tratamiento hubiera durado m&#225;s o se hubiera iniciado a edades m&#225;s tempranas&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">La dosis de lipasa ajustada por peso se redujo progresivamente en todos los pacientes durante el tratamiento&#44; aunque el ajuste se bas&#243; en datos cl&#237;nicos sin monitorizaci&#243;n exhaustiva de la funci&#243;n pancre&#225;tica&#46; La mejor&#237;a observada podr&#237;a haber sido sesgada por la ganancia de peso&#44; aunque en 2 pacientes tambi&#233;n hubo una reducci&#243;n significativa en la dosis total&#46; Es posible que este efecto est&#233; asociado a la normalizaci&#243;n del pH gastrointestinal resultante del tratamiento con ivacaftor<a class="elsevierStyleCrossRef" href="#bib0190"><span class="elsevierStyleSup">11</span></a> o al aumento en la permeabilidad de los conductos pancre&#225;ticos&#46; Cabe mencionar que se observ&#243; una mejor&#237;a significativa en la paciente 4 a pesar del inicio tard&#237;o del tratamiento&#44; lo que sugiere la posibilidad de que los cambios observados en la funci&#243;n pancre&#225;tica no sean completamente irreversibles&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">La comparaci&#243;n de los datos del seguimiento con los del a&#241;o previo mostr&#243; que los aislamientos de <span class="elsevierStyleItalic">P&#46; aeruginosa</span> fueron menos frecuentes durante el tratamiento&#44; lo que probablemente se deba a la mejor&#237;a en el aclaramiento mucociliar producida por el ivacaftor<a class="elsevierStyleCrossRefs" href="#bib0190"><span class="elsevierStyleSup">11&#44;12</span></a>&#46; Tambi&#233;n se redujo la necesidad de antibioterapia oral e intravenosa&#44; un hallazgo importante&#44; pues las exacerbaciones tienen un impacto significativo en la calidad de vida<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">13</span></a> y se asocian a un deterioro de la funci&#243;n pulmonar que en ocasiones no retorna a los valores previos<a class="elsevierStyleCrossRef" href="#bib0205"><span class="elsevierStyleSup">14</span></a>&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">Otros estudios han descrito efectos adicionales del ivacaftor en la sinusitis&#44; la secreci&#243;n de insulina&#44; la esteatosis hep&#225;tica y la enfermedad pulmonar grave<a class="elsevierStyleCrossRefs" href="#bib0210"><span class="elsevierStyleSup">15&#8211;20</span></a>&#46; El ivacaftor tambi&#233;n se ha mostrado eficaz en el tratamiento de otras mutaciones de clase III y de pacientes de 18 a&#241;os de edad o mayores con la mutaci&#243;n de clase IV Arg117His-CFTR<a class="elsevierStyleCrossRefs" href="#bib0240"><span class="elsevierStyleSup">21&#8211;23</span></a>&#46;</p><p id="par0140" class="elsevierStylePara elsevierViewall">Se observ&#243; mejor&#237;a radiol&#243;gica en 3 pacientes durante el tratamiento&#46; En un paciente se resolvi&#243; la infecci&#243;n por <span class="elsevierStyleItalic">M&#46; abscessus</span> con remisi&#243;n de ABPA recurrente&#44; lo que pudo haber contribuido a la mejor&#237;a radiol&#243;gica&#46; El ivacaftor reduce la inflamaci&#243;n de la v&#237;a a&#233;rea y aumenta el aclaramiento mucociliar&#44; por lo que los cambios en pruebas de imagen podr&#237;an utilizarse como marcadores objetivos para verificar la respuesta al tratamiento de cada paciente<a class="elsevierStyleCrossRefs" href="#bib0255"><span class="elsevierStyleSup">24&#8211;26</span></a>&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">El ivacaftor fue bien tolerado y no se asociaron efectos adversos a su uso&#46; Los estudios postautorizaci&#243;n son esenciales para garantizar la seguridad de los f&#225;rmacos y detectar los efectos adversos que pueden surgir a largo plazo en situaciones cl&#237;nicas diversas y con el uso concomitante de otros f&#225;rmacos con posibles interacciones&#46; Recientemente se confirm&#243; la seguridad de ivacaftor en ni&#241;os de 2 a 5 a&#241;os&#44; aunque la elevaci&#243;n de los niveles de transaminasas fue un hallazgo frecuente<a class="elsevierStyleCrossRef" href="#bib0270"><span class="elsevierStyleSup">27</span></a>&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">La muestra de nuestro estudio solo incluy&#243; 4 pacientes&#44; y uno recibi&#243; &#250;nicamente 12 meses de tratamiento&#46; Adem&#225;s&#44; es posible que la mejor&#237;a observada en la funci&#243;n pulmonar y otras variables no se debiera exclusivamente al tratamiento con ivacaftor&#44; sino tambi&#233;n al inicio del manejo multidisciplinar de la FQ &#40;paciente 4&#41; o a la resoluci&#243;n de una infecci&#243;n por <span class="elsevierStyleItalic">M&#46; abscessus</span> asociada a ABPA &#40;paciente 1&#41;&#46; En cualquier caso&#44; ambos pacientes siguieron mejorando a lo largo del seguimiento&#46; El objetivo de nuestro estudio no era obtener medidas espec&#237;ficas de mejora&#44; que ya se han descrito extensamente en estudios previos&#44; sino proporcionar datos sobre la efectividad y la seguridad de ivacaftor en situaciones cl&#237;nicas diferentes y complejas que se dan en la vida real&#44; como las infecciones concomitantes&#44; el uso de f&#225;rmacos que podr&#237;an interaccionar con ivacaftor y pacientes inestables&#46; Adem&#225;s&#44; para el an&#225;lisis comparativo con el a&#241;o previo se excluy&#243; al paciente 4-&#46;</p><p id="par0155" class="elsevierStylePara elsevierViewall">La mutaci&#243;n G551D afecta solamente al 5&#37; de los pacientes en el Reino Unido&#46; Esta limitaci&#243;n reduce la posibilidad de incluir un mayor n&#250;mero de pacientes procedentes de una sola unidad de FQ y ser&#237;a recomendable realizar estudios multic&#233;ntricos que valoren las situaciones en la vida real&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">En conclusi&#243;n&#44; llevamos a cabo un estudio de la evoluci&#243;n en vida real de 4 ni&#241;os con FQ y la mutaci&#243;n G551D en quienes el tratamiento con ivacaftor se asoci&#243; a mejoras significativas en la funci&#243;n pulmonar&#44; el estado nutricional&#44; las dosis de lipasa&#44; el cloro en sudor&#44; el aislamiento de <span class="elsevierStyleItalic">P&#46; aeruginosa</span> y el uso de antibi&#243;ticos&#46; Por a&#241;adidura&#44; se confirm&#243; la efectividad y seguridad del ivacaftor en situaciones cl&#237;nicas que no se tienen en consideraci&#243;n en ensayos cl&#237;nicos&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Conflicto de intereses</span><p id="par0165" class="elsevierStylePara elsevierViewall">Los autores declaran no tener ning&#250;n conflicto de intereses&#46;</p></span></span>"
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          "titulo" => "Abstract"
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              "titulo" => "Introduction"
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            0 => "Fibrosis qu&#237;stica"
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            2 => "Vida real"
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            0 => "Cystic fibrosis"
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        "titulo" => "Resumen"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introducci&#243;n</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Ivacaftor es un potenciador de la prote&#237;na reguladora de la conductancia transmembrana de la fibrosis qu&#237;stica &#40;CFTR&#41; que ha demostrado en ensayos cl&#237;nicos mejor&#237;a del estado nutricional y la funci&#243;n pulmonar de pacientes con fibrosis qu&#237;stica con mutaci&#243;n G551D&#46; El objetivo de este estudio es describir la evoluci&#243;n en la vida real de ni&#241;os tratados con ivacaftor&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">M&#233;todos</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Se describe la evoluci&#243;n en vida real de 4 ni&#241;os con fibrosis qu&#237;stica con genotipo F508del&#47;G551D comparando los datos durante el tratamiento con ivacaftor respecto a la situaci&#243;n basal y al a&#241;o previo al tratamiento&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Resultados</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Se analizan 4 ni&#241;os de entre 6 y 14 a&#241;os&#44; incluyendo uno con diagn&#243;stico reciente de fibrosis qu&#237;stica y otro con infecci&#243;n persistente por <span class="elsevierStyleItalic">Mycobacterium abscessus &#40;M&#46; abscessus&#41;</span> y aspergilosis broncopulmonar al&#233;rgica &#40;ABPA&#41; recurrente&#46; El volumen espiratorio forzado en el primer segundo &#40;FEV<span class="elsevierStyleInf">1</span>&#41; basal fue del 58&#44;5-81&#44;8&#37; del predicho y recibieron ivacaftor 24 meses de media &#40;rango 12-30 meses&#41;&#46; Todos los pacientes tuvieron una mejor&#237;a significativa y mantenida de la funci&#243;n pulmonar&#46; Respecto a la situaci&#243;n basal&#44; el z-score del peso mejor&#243; 1&#44;53 puntos y el z-score del &#237;ndice de masa corporal &#40;IMC&#41; 1&#44;6 puntos&#46; Comparado con el a&#241;o previo al tratamiento con ivacaftor&#44; disminuyeron la frecuencia de aislamientos de <span class="elsevierStyleItalic">Pseudomonas aeruginosa &#40;P&#46; aeruginosa&#41;</span> &#40;&#8722;0&#44;4&#47;paciente&#47;a&#241;o&#41; y el n&#250;mero de exacerbaciones respiratorias &#40;&#8722;1&#44;8&#47;paciente&#47;a&#241;o&#41;&#46; La dosis de lipasa ajustada por kilo disminuy&#243; progresivamente en todos los pacientes&#46; Un paciente resolvi&#243; durante el tratamiento la infecci&#243;n por <span class="elsevierStyleItalic">M&#46; abscessus</span> y la ABPA&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusiones</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Los ni&#241;os con fibrosis qu&#237;stica y mutaci&#243;n F508del&#47;G551D tratados con ivacaftor mostraron en la vida real mejor&#237;a de la funci&#243;n pulmonar&#44; el estado nutricional&#44; las exacerbaciones respiratorias&#44; los aislamientos de <span class="elsevierStyleItalic">P&#46; aeruginosa</span> y la dosis de enzimas pancre&#225;ticas&#46;</p></span>"
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            "identificador" => "abst0005"
            "titulo" => "Introducci&#243;n"
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          1 => array:2 [
            "identificador" => "abst0010"
            "titulo" => "M&#233;todos"
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introduction</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Ivacaftor is a cystic fibrosis transmembrane conductance regulator &#40;CFTR&#41; potentiator that has been shown to improve the nutritional status and lung function of cystic fibrosis patients with the G551D mutation in clinical trials&#46; The objective of this study was to describe the real-world progress of children receiving ivacaftor&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Methods</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">We describe the real-world progress of four children with cystic fibrosis and the F508del&#47;G551D genotype comparing data during ivacaftor treatment with baseline and with the year before commencing treatment&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Results</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Our sample comprised 4 children aged between 6 and 14 years and including one with a recent diagnosis of CF and other with persistent <span class="elsevierStyleItalic">Mycobacterium abscessus &#40;M&#46; abscessus&#41;</span> and recurrent allergic bronchopulmonary aspergillosis&#46; The baseline FEV1 was 58&#46;5&#37; to 81&#46;8&#37; of the predicted value&#44; and ivacaftor was taken for a mean 24 months &#40;range&#44; 12-30 months&#41;&#46; All patients experienced a significant and sustained improvement in lung function&#46; Compared to baseline&#44; the weight <span class="elsevierStyleItalic">z</span>-score improved by 1&#46;53 points&#44; and the BMI <span class="elsevierStyleItalic">z</span>-score by 1&#46;6 points&#46; Compared to the year before starting ivacaftor&#44; the frequency of <span class="elsevierStyleItalic">Pseudomonas aeruginosa &#40;P&#46; aeruginosa&#41;</span> isolates decreased &#40;&#8722;0&#46;4&#47;patient&#47;year&#41;&#44; as did the number of respiratory exacerbations &#40;&#8722;1&#46;8&#47;patient&#47;year&#41;&#46; The weight-adjusted dose of lipase per kilogram decreased progressively in all patients&#46; In 1 patient&#44; a previously persistent <span class="elsevierStyleItalic">M&#46; abscessus</span> infection and recurrent allergic bronchopulmonary aspergillosis resolved during treatment&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusions</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Children with cystic fibrosis and the F508del&#47;G551D genotype receiving treatment with ivacaftor experienced a real-world improvement in lung function&#44; nutritional status&#44; respiratory exacerbations&#44; isolation of <span class="elsevierStyleItalic">P&#46; aeruginosa</span>&#44; and dose of pancreatic enzymes&#46;</p></span>"
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                  \t\t\t\t">13 a&#241;os&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">Cloro en sudor al diagn&#243;stico&#44; mmol&#47;l&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">126&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">96&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">99&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">90&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Genotipo&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">F508del&#47;G551D&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">F508del&#47;G551D&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">F508del&#47;G551D&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">F508del&#47;G551D&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Insuficiencia pancre&#225;tica&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">S&#237;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">S&#237;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">S&#237;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">S&#237;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Edad al inicio de ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">10 a&#241;os&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">7 a&#241;os&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">6 a&#241;os&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">14 a&#241;os&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Duraci&#243;n de tratamiento con ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">30 meses&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">30 meses&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">24 meses&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">12 meses&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Microrganismos detectados al inicio de ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Mycobacterium abscessus</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">No&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">No&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">No&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">N&#250;mero de aislamientos de <span class="elsevierStyleItalic">Pseudomonas aeruginosa</span> en el a&#241;o previo al tratamiento con ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Sin datos&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">A&#241;o previo&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">0-6 meses de ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">7-12 meses de ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">13-18 meses de ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">19-24 meses de ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">25-30 meses de ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&#218;ltima espirometr&#237;a&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " colspan="9" align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Paciente 1</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>N&#250;mero de espirometr&#237;as&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">10&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>FEV<span class="elsevierStyleInf">1</span> &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">64&#44;7 &#40;10&#44;8&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">63&#44;9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">60&#44;7 &#40;5&#44;6&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">70&#44;4 &#40;15&#44;6&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">81&#44;3 &#40;4&#44;0&#41;<a class="elsevierStyleCrossRef" href="#tblfn0005">&#42;</a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">77&#44;2 &#40;2&#44;0&#41;<a class="elsevierStyleCrossRef" href="#tblfn0005">&#42;</a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">76&#44;8 &#40;1&#44;5&#41;<a class="elsevierStyleCrossRef" href="#tblfn0005">&#42;</a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">78&#44;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>FVC &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">85&#44;9 &#40;5&#44;6&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Paciente 4</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>N&#250;mero de espirometr&#237;as&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>FEV<span class="elsevierStyleInf">1</span> &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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          "leyenda" => "<p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">IMC&#58; &#237;ndice de masa corporal&#46;</p><p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">Datos expresados como frecuencias absolutas o media &#40;DE&#41;&#46;</p><p id="spar0085" class="elsevierStyleSimplePara elsevierViewall">La significaci&#243;n estad&#237;stica se calcul&#243; con respecto al a&#241;o previo a iniciarse el tratamiento&#58;</p>"
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">6 meses de ivacaftor&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">1 a&#241;o de ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">2 a&#241;os de ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Paciente 1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">96&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">36&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">42&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">23&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">37&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Paciente 2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">96&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">43&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">66&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">36&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">37&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Paciente 3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">91&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">26&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">28&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">28&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Paciente 4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">90&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">36&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">39&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
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        "descripcion" => array:1 [
          "es" => "<p id="spar0090" class="elsevierStyleSimplePara elsevierViewall">Valores de cloro en sudor &#40;mmol&#47;l&#41; antes del inicio y durante el tratamiento con ivacaftor</p>"
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      "titulo" => "Bibliograf&#237;a"
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ORIGINAL
Efectividad de ivacaftor en vida real en niños con fibrosis quística y mutación G551D
Real-world effectiveness of ivacaftor in children with cystic fibrosis and the G551D mutation
David Gomez-Pastranaa,b,
Autor para correspondencia
dgpastranad@gmail.com

Autor para correspondencia.
, Chinedu Nwokorob, Mike McLeanb, Sarah Brownb, Nanna Christiansenb, Caroline S. Paob
a Unidad de Neumología Infantil, Hospital de Jerez, Jerez de la Frontera, Cádiz, España
b Paediatric Cystic Fibrosis Centre, The Children's Hospital at the Royal London, Barts Health NHS Trust, Londres, Reino Unido
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se recogieron datos sobre medidas antropom&#233;tricas&#44; la dosis de enzimas pancre&#225;ticas&#44; los ciclos de antibi&#243;ticos&#44; la frecuencia del aislamiento de microorganismos y la funci&#243;n pulmonar&#44; as&#237; como muestras cl&#237;nicas &#40;esputo&#44; frotis far&#237;ngeo&#41;&#46; En los pacientes tratados con ivacaftor tambi&#233;n se realizaron determinaciones seriadas de transaminasas y cloro en sudor antes de iniciarse el tratamiento y a las 6 semanas&#44; 6 meses&#44; un a&#241;o y 2 a&#241;os de tratamiento&#46; Para calcular los valores de referencia sobre el predicho del FEV<span class="elsevierStyleInf">1</span> &#40;FEV1&#37;&#41;&#44; la capacidad vital forzada &#40;FVC&#37;&#41; y los mesoflujos &#40;FEF<span class="elsevierStyleInf">25&#37;-75&#37;</span>&#41; se utilizaron las ecuaciones propuestas por la Global Lung Function Initiative&#46; El z-score del peso&#44; talla e IMC se calcul&#243; con las tablas publicadas por la Organizaci&#243;n Mundial de la Salud&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Se incluyeron todos los pacientes menores de 17 a&#241;os con una o m&#225;s mutaciones G551D tratados con ivacaftor entre enero de 2013 y junio de 2015&#44; independientemente de la duraci&#243;n del tratamiento&#46; La dosis administrada fue de 150<span class="elsevierStyleHsp" style=""></span>mg&#47;12<span class="elsevierStyleHsp" style=""></span>h una vez al d&#237;a&#44; o dos veces por semana en caso de tratamiento concomitante con f&#225;rmacos inhibidores de citocromo P450 3<span class="elsevierStyleHsp" style=""></span>A&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Se incluyeron todos los datos recogidos durante el tratamiento con ivacaftor y los del a&#241;o previo cuando estaban disponibles&#46; El an&#225;lisis se bas&#243; en los valores basales y los &#250;ltimos valores obtenidos durante el tratamiento con ivacaftor&#46; Tambi&#233;n se calcularon los valores medios de los datos recogidos durante el tratamiento&#44; agrupados en intervalos de 6 meses&#46; Las comparaciones se realizaron con el valor basal &#40;definido como el valor registrado m&#225;s recientemente antes de administrarse la primera dosis de ivacaftor&#41; o el primer valor disponible&#44; as&#237; como con el valor medio del a&#241;o previo al inicio del tratamiento&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">El an&#225;lisis estad&#237;stico se realiz&#243; con el software SPSS 19&#46;0&#46; El nivel de significaci&#243;n estad&#237;stica se estableci&#243; en p &#60;<span class="elsevierStyleHsp" style=""></span>0&#44;05&#46; La media y desviaci&#243;n est&#225;ndar &#40;DE&#41; de los datos agrupados a intervalos de 6 meses y la de los obtenidos el a&#241;o previo al tratamiento se compararon mediante an&#225;lisis de varianza&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Resultados</span><p id="par0045" class="elsevierStylePara elsevierViewall">Se incluyeron 4 pacientes de 6 a 14 a&#241;os de edad que hab&#237;an recibido ivacaftor durante una media de 24 meses &#40;12 meses&#44; 24 meses&#44; 30 meses&#44; 30 meses&#41;&#46; Todos eran heterocigotos F508del&#47;G551D y ten&#237;an insuficiencia pancre&#225;tica &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">tabla 1</a>&#41;&#46; En dos pacientes se inici&#243; tratamiento con ivacaftor cuando fue autorizado en el Reino Unido en enero de 2013&#59; el paciente 3 tuvo que esperar hasta que cumpli&#243; los 6 a&#241;os en mayo de 2013&#46; El estado cl&#237;nico de los pacientes al inicio de ivacaftor era muy variado&#46; El paciente 1 hab&#237;a sido diagnosticado de aspergilosis broncopulmonar al&#233;rgica &#40;ABPA&#41; con varias reca&#237;das en los 5 a&#241;os anteriores&#44; as&#237; como en los primeros meses de tratamiento con ivacaftor&#44; que se trataron repetidamente con prednisolona junto con itraconazol o voriconazol&#46; Este paciente hab&#237;a tambi&#233;n sido diagnosticado de enfermedad pulmonar por <span class="elsevierStyleItalic">M&#46; abscessus</span> 7 meses antes de iniciarse el tratamiento con ivacaftor&#44; con aislamiento recurrente de <span class="elsevierStyleItalic">M&#46; abscessus</span> asociado a deterioro de la funci&#243;n pulmonar y hallazgos patol&#243;gicos en la tomograf&#237;a computarizada &#40;TC&#41;&#46; Hab&#237;a recibido tratamiento de erradicaci&#243;n con antibioterapia intensiva intravenosa&#44; nebulizada y oral conforme a las recomendaciones vigentes&#46; No obstante&#44; el paciente continu&#243; teniendo cultivos positivos a <span class="elsevierStyleItalic">M&#46; abscessus</span> antes de iniciarse el tratamiento con ivacaftor a pesar de la terapia de mantenimiento nebulizada y oral&#46; En los primeros meses&#44; el paciente recibi&#243; dosis reducidas de ivacaftor dos veces por semana debido al tratamiento concomitante con claritromicina y voriconazol&#46; Durante el tratamiento con ivacaftor&#44; se negativizaron los cultivos de <span class="elsevierStyleItalic">M&#46; abscessus</span> y no tuvo m&#225;s episodios de ABPA&#46; A los 6 meses se interrumpi&#243; el tratamiento con claritromicina y voriconazol y el paciente comenz&#243; a recibir la pauta est&#225;ndar de ivacaftor con dosis diarias&#46; A la finalizaci&#243;n del estudio&#44; el paciente llevaba 21 meses sin presentar <span class="elsevierStyleItalic">M&#46; abscessus</span> ni ABPA&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0050" class="elsevierStylePara elsevierViewall">En el caso de la paciente 3&#44; no se dispuso de datos fiables de espirometr&#237;a hasta los 6 meses de tratamiento con ivacaftor&#46; La paciente 4 se diagnostic&#243; de fibrosis qu&#237;stica a los 13 a&#241;os y comenz&#243; tratamiento con ivacaftor junto con el inicio de la terapia multidisciplinar de la enfermedad y un ciclo de antibioterapia intravenosa&#46; En la actualidad los 4 pacientes contin&#250;an recibiendo tratamiento con ivacaftor&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">La funci&#243;n pulmonar &#8212;y especialmente el FEV<span class="elsevierStyleInf">1</span> y los mesoflujos&#8212; mejor&#243; en los 4 pacientes&#44; y esta mejora se mantuvo durante todo el seguimiento &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">tabla 2</a>&#41;&#46; Los valores basales de FEV<span class="elsevierStyleInf">1</span>&#37; oscilaron entre el 58&#44;5 y el 81&#44;8&#37;&#46; Al comparar los &#250;ltimos valores registrados durante el tratamiento con los valores basales &#40;en el caso del paciente 3&#44; el primer valor fiable&#41;&#44; se observ&#243; una mejor&#237;a global del FEV<span class="elsevierStyleInf">1</span>&#37; de 25&#44;72 puntos porcentuales&#46; Cuando comparamos los valores finales con los valores medios del a&#241;o anterior a iniciar el tratamiento en los pacientes 1 y 2&#44; observamos una mejor&#237;a global del FEV<span class="elsevierStyleInf">1</span>&#37; de 18&#44;85 puntos porcentuales&#46; Cuando se incluyeron en el an&#225;lisis todos los valores de la funci&#243;n pulmonar obtenidos durante el tratamiento&#44; la mejor&#237;a global en el FEV<span class="elsevierStyleInf">1</span>&#37; fue de 11&#44;96 puntos porcentuales respecto al valor basal&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0060" class="elsevierStylePara elsevierViewall">La mejor&#237;a global de los mesoflujos al final del seguimiento fue de 46&#44;65 puntos porcentuales respecto a los valores basales&#46; La FVC&#37; mejor&#243; en 3 de los pacientes durante el tratamiento&#44; mientras que el cociente FEV1&#47;FVC mejor&#243; significativamente en uno&#46; La mejor&#237;a global de la FVC&#37; al final del seguimiento fue de 12&#44;75 puntos porcentuales con respecto al valor basal&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">El estado nutricional&#44; evaluado mediante el z-score del IMC&#44; mejor&#243; progresivamente en todos los pacientes durante el tratamiento con ivacaftor &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">tabla 3</a>&#41;&#46; La mejor&#237;a absoluta de la puntuaci&#243;n z-score en la &#250;ltima evaluaci&#243;n antropom&#233;trica durante el tratamiento en comparaci&#243;n con los valores basales fue de 1&#44;6 puntos&#46; Cuando agrupamos los valores de los pacientes 1&#44; 2 y 3 al final del seguimiento y los comparamos con los valores del a&#241;o previo al inicio del tratamiento&#44; observamos un aumento de 0&#44;50 puntos en el z-score medio&#46; Cuando se incluyeron todos los valores registrados en los pacientes 1-3 durante el tratamiento&#44; encontramos una mejor&#237;a similar en el z-score &#40;1&#44;37 puntos con respecto al valor basal&#44; y 0&#44;54 con respecto al a&#241;o previo&#41;&#46;</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><p id="par0070" class="elsevierStylePara elsevierViewall">Tambi&#233;n se observaron mejor&#237;as en el peso corporal que se mantuvieron constantes durante el seguimiento&#46; El z-score del peso al final del seguimiento mejor&#243; 1&#44;53 puntos respecto al basal y 0&#44;50 puntos respecto al a&#241;o previo al tratamiento en los pacientes 1-3&#46; La mejor&#237;a en el z-score de la talla fue mucho m&#225;s modesta&#44; con un aumento al final del seguimiento de 0&#44;41 puntos respecto al basal&#44; y de 0&#44;01 puntos con respecto al a&#241;o previo en los pacientes 1-3&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">La dosis de lipasa por kilogramo de peso corporal se redujo significativamente y de manera gradual en los 4 pacientes &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">tabla 3</a>&#41;&#46; Cuando analizamos conjuntamente las dosis de los pacientes 1-3&#44; encontramos una reducci&#243;n del 39&#44;5&#37; al final del seguimiento en comparaci&#243;n con el momento inicial&#46; Asimismo&#44; la dosis total de enzimas pancre&#225;ticas se redujo en 2 pacientes&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">Antes de iniciarse el tratamiento con ivacaftor&#44; la concentraci&#243;n de cloro en sudor era &#8805; 90 mEq&#47;l en todos los pacientes&#46; Este valor hab&#237;a disminuido significativamente cuando se hizo el primer control a las 6 semanas&#46; En los 3 pacientes que hab&#237;an sido tratados con ivacaftor durante 2 o m&#225;s a&#241;os&#44; la &#250;ltima determinaci&#243;n revel&#243; valores de menos de 40 mEq&#47;l &#40;<a class="elsevierStyleCrossRef" href="#tbl0020">tabla 4</a>&#41;&#46; La reducci&#243;n media al final del seguimiento fue de &#8211;58 mEq&#47;l&#46;</p><elsevierMultimedia ident="tbl0020"></elsevierMultimedia><p id="par0085" class="elsevierStylePara elsevierViewall">El n&#250;mero de aislamientos de <span class="elsevierStyleItalic">P&#46; aeruginosa</span> de muestras de secreciones respiratorias fue bajo en general&#44; y disminuy&#243; ligeramente con respecto al a&#241;o previo a la iniciaci&#243;n de ivacaftor en los pacientes 1-3 &#40;ninguno tuvo una infecci&#243;n cr&#243;nica&#41;&#46; El n&#250;mero medio de aislamientos de <span class="elsevierStyleItalic">P&#46; aeruginosa</span> fue de 0&#44;67 por paciente&#47;a&#241;o durante el a&#241;o previo al tratamiento &#40;pacientes 1-3&#41; y de 0&#44;27 por paciente&#47;a&#241;o durante el tratamiento&#46; El n&#250;mero de exacerbaciones respiratorias que requirieron antibioterapia tambi&#233;n disminuy&#243; en los pacientes 1-3 con respecto al a&#241;o previo&#44; tanto para la antibioterapia oral &#40;3 vs&#46; 1&#44;7 ciclos por paciente&#47;a&#241;o&#41; como para la intravenosa &#40;uno vs&#46; 0&#44;5 ciclos por paciente&#47;a&#241;o&#41;&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">Se observ&#243; mejor&#237;a radiol&#243;gica en 3 pacientes&#46; En el paciente 1&#44; la TC mostr&#243; una mejor&#237;a significativa&#44; aunque la comparaci&#243;n se realiz&#243; al finalizarse el tratamiento para la infecci&#243;n por <span class="elsevierStyleItalic">M&#46; abscessus</span> y la ABPA&#46; Seg&#250;n el informe del radi&#243;logo&#44; la radiograf&#237;a del paciente 2 mostr&#243; resoluci&#243;n del engrosamiento peribronquial en la base del pulm&#243;n izquierdo en comparaci&#243;n con la radiograf&#237;a previa&#46; La paciente 4 presentaba bronquiectasias significativas al diagn&#243;stico&#44; que mejoraron considerablemente durante el tratamiento&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">El &#250;nico efecto adverso que se observ&#243; en el estudio fue una elevaci&#243;n leve y transitoria en los niveles s&#233;ricos de transaminasas en el paciente 1 &#40;AST&#44; 43 UI&#47;ml&#59; ALT&#44; 42 UI&#47;ml&#41;&#46; No se observaron problemas de adherencia&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Discusi&#243;n</span><p id="par0100" class="elsevierStylePara elsevierViewall">En este estudio de la evoluci&#243;n en vida real de 4 pacientes con FQ y genotipo F508del&#47;G551D&#44; el uso de ivacaftor se asoci&#243; a mejor&#237;as en la funci&#243;n pulmonar&#44; el estado nutricional&#44; la dosis de enzimas pancre&#225;ticas&#44; el cloro en sudor&#44; el n&#250;mero de aislamientos de <span class="elsevierStyleItalic">P&#46; aeruginosa</span> y el uso de antibi&#243;ticos&#46; Aunque estudios previos sobre el uso de ivacaftor ya hab&#237;an reportado mejor&#237;as en muchos de estos par&#225;metros&#44; los estudios con datos en la vida real ofrecen un valor a&#241;adido de efectividad&#46; La practica cl&#237;nica difiere significativamente de los protocolos de ensayos cl&#237;nicos que adem&#225;s excluyen a muchos pacientes por no cumplir los criterios de inclusi&#243;n&#46; As&#237;&#44; 3 de los 4 pacientes en el presente estudio no est&#225;n representados en los ensayos cl&#237;nicos&#46; El paciente 1 fue tratado con inhibidores del citocromo P450 3<span class="elsevierStyleHsp" style=""></span>A durante 9 meses&#44; lo que era motivo de exclusi&#243;n en los ensayos cl&#237;nicos de ivacaftor<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">8</span></a>&#46; En el caso de la paciente 3&#44; de 6 a&#241;os de edad&#44; no se dispuso de datos espirom&#233;tricos fiables hasta los 6 meses de tratamiento&#46; La paciente 4 recibi&#243; un diagn&#243;stico tard&#237;o y comenz&#243; tratamiento con ivacaftor a la vez que iniciaba el tratamiento multidisciplinar de la fibrosis qu&#237;stica&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">En el presente estudio se analizaron todos los datos de la funci&#243;n pulmonar y antropometr&#237;a registrados durante el tratamiento con ivacaftor y tambi&#233;n durante el a&#241;o previo a su iniciaci&#243;n&#46; En los ensayos cl&#237;nicos&#44; el protocolo requiere una evaluaci&#243;n basal de la funci&#243;n pulmonar&#44; cuyos resultados se comparan con los obtenidos tras un per&#237;odo preestablecido&#44; normalmente a intervalos de 8-12 semanas&#46; Sin embargo&#44; los pacientes con FQ experimentan fluctuaciones frecuentes en la funci&#243;n pulmonar y el peso corporal debido a las exacerbaciones respiratorias y complicaciones diversas&#46; En este sentido&#44; consideramos que la inclusi&#243;n de todos los datos recogidos durante el per&#237;odo de estudio a&#241;ade valor en lo concerniente a la efectividad real de ivacaftor&#46; Adem&#225;s&#44; la comparaci&#243;n con valores del a&#241;o previo puede incrementar a&#250;n m&#225;s la precisi&#243;n del an&#225;lisis&#44; ya que es posible que el estado del paciente al inicio del tratamiento no refleje su situaci&#243;n en los meses previos&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">La mejor&#237;a en el FEV<span class="elsevierStyleInf">1</span>&#37; con respecto al valor basal &#40;25&#44;72 puntos porcentuales&#41; fue mayor que la observada en estudios previos &#40;10&#44;6 y 12&#44;5 puntos a las 24 semanas y 10&#44;5 y 10 puntos a las 48 semanas<a class="elsevierStyleCrossRefs" href="#bib0175"><span class="elsevierStyleSup">8&#44;9</span></a>&#41;&#46; Tres de nuestros pacientes ten&#237;an un FEV<span class="elsevierStyleInf">1</span>&#37; basal &#8804;70&#44;3&#37;&#44; mientras que la mayor&#237;a de los pacientes en los estudios ENVISION y PERSIST ten&#237;an valores basales de FEV<span class="elsevierStyleInf">1</span>&#37; &#62; 70&#37;&#46; En el estudio ENVISION los pacientes con mayor gravedad&#44; expresada por un menor cociente FEV<span class="elsevierStyleInf">1</span>&#47;FVC &#40;&#8804; 0&#44;748&#41; o FEV<span class="elsevierStyleInf">1</span>&#37; basal &#40;50-80&#37;&#41;&#44; fueron tambi&#233;n los que mostraron mayor efecto del tratamiento&#44; con una mejor&#237;a del FEV<span class="elsevierStyleInf">1</span>&#37; de alrededor de 20 puntos<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">8</span></a>&#46; Adem&#225;s&#44; el mayor incremento en el FEV<span class="elsevierStyleInf">1</span>&#37; en nuestro estudio se registr&#243; en la paciente 4 &#40;49&#44;5 puntos&#41;&#44; en la que se inici&#243; el programa de manejo multidisciplinar &#40;incluyendo antibioterapia intravenosa&#41; cuando comenz&#243; el tratamiento con ivacaftor&#44; por lo que parte de la mejor&#237;a observada en este caso podr&#237;a deberse al manejo general de la FQ&#46; No obstante&#44; la mejor&#237;a observada en su TC super&#243; las expectativas&#46; Cuando comparamos los resultados de los pacientes 1 y 2 con el valor medio del a&#241;o previo a la iniciaci&#243;n de ivacaftor&#44; encontramos un aumento de 18&#44;85 puntos porcentuales en el FEV<span class="elsevierStyleInf">1</span>&#37;&#44; lo que concuerda m&#225;s con los resultados de los ensayos cl&#237;nicos&#46; La mejor&#237;a obtenida con el ivacaftor podr&#237;a alterar el deterioro progresivo de la funci&#243;n pulmonar caracter&#237;stico de la historia natural de la FQ<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">10</span></a>&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">La mejor&#237;a en los mesoflujos tambi&#233;n fue mayor que la descrita en los ensayos cl&#237;nicos&#44; probablemente por las razones ya mencionadas en relaci&#243;n con el FEV<span class="elsevierStyleInf">1</span>&#44; mientras que la mejor&#237;a en la FVC fue modesta&#46; El incremento en el cociente FEV<span class="elsevierStyleInf">1</span>&#47;FVC observado en el paciente 1 probablemente se debi&#243; a la mejor&#237;a de la obstrucci&#243;n bronquial tras el tratamiento de la ABPA&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">El estado nutricional&#44; evaluado por medio del z-score del IMC&#44; mejor&#243; r&#225;pidamente y de manera sostenida en todos los pacientes durante el tratamiento&#46; La mejor&#237;a global de 1&#44;6 puntos se debe en parte a la mejor&#237;a de 4&#44;7 puntos en la paciente 4&#44; a la que tambi&#233;n contribuy&#243; el manejo multidisciplinar de la FQ y el inicio de la terapia con enzimas pancre&#225;ticas&#59; al excluir a esta paciente del an&#225;lisis&#44; la mejor&#237;a global fue de 0&#44;57 puntos con respecto al z-score basal y de 0&#44;50 puntos con respecto al a&#241;o previo&#46; Estos hallazgos fueron similares a los del estudio ENVISION a las 48 semanas de tratamiento &#40;en comparaci&#243;n con el grupo de control&#41;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">8</span></a>&#46; Los cambios de peso siguieron un patr&#243;n similar al de los cambios del IMC&#46; Sin embargo&#44; el incremento en el z-score de la talla fue muy modesto&#44; aunque es posible que se hubieran registrado diferencias mayores si el tratamiento hubiera durado m&#225;s o se hubiera iniciado a edades m&#225;s tempranas&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">La dosis de lipasa ajustada por peso se redujo progresivamente en todos los pacientes durante el tratamiento&#44; aunque el ajuste se bas&#243; en datos cl&#237;nicos sin monitorizaci&#243;n exhaustiva de la funci&#243;n pancre&#225;tica&#46; La mejor&#237;a observada podr&#237;a haber sido sesgada por la ganancia de peso&#44; aunque en 2 pacientes tambi&#233;n hubo una reducci&#243;n significativa en la dosis total&#46; Es posible que este efecto est&#233; asociado a la normalizaci&#243;n del pH gastrointestinal resultante del tratamiento con ivacaftor<a class="elsevierStyleCrossRef" href="#bib0190"><span class="elsevierStyleSup">11</span></a> o al aumento en la permeabilidad de los conductos pancre&#225;ticos&#46; Cabe mencionar que se observ&#243; una mejor&#237;a significativa en la paciente 4 a pesar del inicio tard&#237;o del tratamiento&#44; lo que sugiere la posibilidad de que los cambios observados en la funci&#243;n pancre&#225;tica no sean completamente irreversibles&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">La comparaci&#243;n de los datos del seguimiento con los del a&#241;o previo mostr&#243; que los aislamientos de <span class="elsevierStyleItalic">P&#46; aeruginosa</span> fueron menos frecuentes durante el tratamiento&#44; lo que probablemente se deba a la mejor&#237;a en el aclaramiento mucociliar producida por el ivacaftor<a class="elsevierStyleCrossRefs" href="#bib0190"><span class="elsevierStyleSup">11&#44;12</span></a>&#46; Tambi&#233;n se redujo la necesidad de antibioterapia oral e intravenosa&#44; un hallazgo importante&#44; pues las exacerbaciones tienen un impacto significativo en la calidad de vida<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">13</span></a> y se asocian a un deterioro de la funci&#243;n pulmonar que en ocasiones no retorna a los valores previos<a class="elsevierStyleCrossRef" href="#bib0205"><span class="elsevierStyleSup">14</span></a>&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">Otros estudios han descrito efectos adicionales del ivacaftor en la sinusitis&#44; la secreci&#243;n de insulina&#44; la esteatosis hep&#225;tica y la enfermedad pulmonar grave<a class="elsevierStyleCrossRefs" href="#bib0210"><span class="elsevierStyleSup">15&#8211;20</span></a>&#46; El ivacaftor tambi&#233;n se ha mostrado eficaz en el tratamiento de otras mutaciones de clase III y de pacientes de 18 a&#241;os de edad o mayores con la mutaci&#243;n de clase IV Arg117His-CFTR<a class="elsevierStyleCrossRefs" href="#bib0240"><span class="elsevierStyleSup">21&#8211;23</span></a>&#46;</p><p id="par0140" class="elsevierStylePara elsevierViewall">Se observ&#243; mejor&#237;a radiol&#243;gica en 3 pacientes durante el tratamiento&#46; En un paciente se resolvi&#243; la infecci&#243;n por <span class="elsevierStyleItalic">M&#46; abscessus</span> con remisi&#243;n de ABPA recurrente&#44; lo que pudo haber contribuido a la mejor&#237;a radiol&#243;gica&#46; El ivacaftor reduce la inflamaci&#243;n de la v&#237;a a&#233;rea y aumenta el aclaramiento mucociliar&#44; por lo que los cambios en pruebas de imagen podr&#237;an utilizarse como marcadores objetivos para verificar la respuesta al tratamiento de cada paciente<a class="elsevierStyleCrossRefs" href="#bib0255"><span class="elsevierStyleSup">24&#8211;26</span></a>&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">El ivacaftor fue bien tolerado y no se asociaron efectos adversos a su uso&#46; Los estudios postautorizaci&#243;n son esenciales para garantizar la seguridad de los f&#225;rmacos y detectar los efectos adversos que pueden surgir a largo plazo en situaciones cl&#237;nicas diversas y con el uso concomitante de otros f&#225;rmacos con posibles interacciones&#46; Recientemente se confirm&#243; la seguridad de ivacaftor en ni&#241;os de 2 a 5 a&#241;os&#44; aunque la elevaci&#243;n de los niveles de transaminasas fue un hallazgo frecuente<a class="elsevierStyleCrossRef" href="#bib0270"><span class="elsevierStyleSup">27</span></a>&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">La muestra de nuestro estudio solo incluy&#243; 4 pacientes&#44; y uno recibi&#243; &#250;nicamente 12 meses de tratamiento&#46; Adem&#225;s&#44; es posible que la mejor&#237;a observada en la funci&#243;n pulmonar y otras variables no se debiera exclusivamente al tratamiento con ivacaftor&#44; sino tambi&#233;n al inicio del manejo multidisciplinar de la FQ &#40;paciente 4&#41; o a la resoluci&#243;n de una infecci&#243;n por <span class="elsevierStyleItalic">M&#46; abscessus</span> asociada a ABPA &#40;paciente 1&#41;&#46; En cualquier caso&#44; ambos pacientes siguieron mejorando a lo largo del seguimiento&#46; El objetivo de nuestro estudio no era obtener medidas espec&#237;ficas de mejora&#44; que ya se han descrito extensamente en estudios previos&#44; sino proporcionar datos sobre la efectividad y la seguridad de ivacaftor en situaciones cl&#237;nicas diferentes y complejas que se dan en la vida real&#44; como las infecciones concomitantes&#44; el uso de f&#225;rmacos que podr&#237;an interaccionar con ivacaftor y pacientes inestables&#46; Adem&#225;s&#44; para el an&#225;lisis comparativo con el a&#241;o previo se excluy&#243; al paciente 4-&#46;</p><p id="par0155" class="elsevierStylePara elsevierViewall">La mutaci&#243;n G551D afecta solamente al 5&#37; de los pacientes en el Reino Unido&#46; Esta limitaci&#243;n reduce la posibilidad de incluir un mayor n&#250;mero de pacientes procedentes de una sola unidad de FQ y ser&#237;a recomendable realizar estudios multic&#233;ntricos que valoren las situaciones en la vida real&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">En conclusi&#243;n&#44; llevamos a cabo un estudio de la evoluci&#243;n en vida real de 4 ni&#241;os con FQ y la mutaci&#243;n G551D en quienes el tratamiento con ivacaftor se asoci&#243; a mejoras significativas en la funci&#243;n pulmonar&#44; el estado nutricional&#44; las dosis de lipasa&#44; el cloro en sudor&#44; el aislamiento de <span class="elsevierStyleItalic">P&#46; aeruginosa</span> y el uso de antibi&#243;ticos&#46; Por a&#241;adidura&#44; se confirm&#243; la efectividad y seguridad del ivacaftor en situaciones cl&#237;nicas que no se tienen en consideraci&#243;n en ensayos cl&#237;nicos&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Conflicto de intereses</span><p id="par0165" class="elsevierStylePara elsevierViewall">Los autores declaran no tener ning&#250;n conflicto de intereses&#46;</p></span></span>"
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          "titulo" => "Abstract"
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              "titulo" => "Introduction"
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    "fechaAceptado" => "2018-05-02"
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            0 => "Fibrosis qu&#237;stica"
            1 => "Ivacaftor"
            2 => "Vida real"
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        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introducci&#243;n</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Ivacaftor es un potenciador de la prote&#237;na reguladora de la conductancia transmembrana de la fibrosis qu&#237;stica &#40;CFTR&#41; que ha demostrado en ensayos cl&#237;nicos mejor&#237;a del estado nutricional y la funci&#243;n pulmonar de pacientes con fibrosis qu&#237;stica con mutaci&#243;n G551D&#46; El objetivo de este estudio es describir la evoluci&#243;n en la vida real de ni&#241;os tratados con ivacaftor&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">M&#233;todos</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Se describe la evoluci&#243;n en vida real de 4 ni&#241;os con fibrosis qu&#237;stica con genotipo F508del&#47;G551D comparando los datos durante el tratamiento con ivacaftor respecto a la situaci&#243;n basal y al a&#241;o previo al tratamiento&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Resultados</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Se analizan 4 ni&#241;os de entre 6 y 14 a&#241;os&#44; incluyendo uno con diagn&#243;stico reciente de fibrosis qu&#237;stica y otro con infecci&#243;n persistente por <span class="elsevierStyleItalic">Mycobacterium abscessus &#40;M&#46; abscessus&#41;</span> y aspergilosis broncopulmonar al&#233;rgica &#40;ABPA&#41; recurrente&#46; El volumen espiratorio forzado en el primer segundo &#40;FEV<span class="elsevierStyleInf">1</span>&#41; basal fue del 58&#44;5-81&#44;8&#37; del predicho y recibieron ivacaftor 24 meses de media &#40;rango 12-30 meses&#41;&#46; Todos los pacientes tuvieron una mejor&#237;a significativa y mantenida de la funci&#243;n pulmonar&#46; Respecto a la situaci&#243;n basal&#44; el z-score del peso mejor&#243; 1&#44;53 puntos y el z-score del &#237;ndice de masa corporal &#40;IMC&#41; 1&#44;6 puntos&#46; Comparado con el a&#241;o previo al tratamiento con ivacaftor&#44; disminuyeron la frecuencia de aislamientos de <span class="elsevierStyleItalic">Pseudomonas aeruginosa &#40;P&#46; aeruginosa&#41;</span> &#40;&#8722;0&#44;4&#47;paciente&#47;a&#241;o&#41; y el n&#250;mero de exacerbaciones respiratorias &#40;&#8722;1&#44;8&#47;paciente&#47;a&#241;o&#41;&#46; La dosis de lipasa ajustada por kilo disminuy&#243; progresivamente en todos los pacientes&#46; Un paciente resolvi&#243; durante el tratamiento la infecci&#243;n por <span class="elsevierStyleItalic">M&#46; abscessus</span> y la ABPA&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusiones</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Los ni&#241;os con fibrosis qu&#237;stica y mutaci&#243;n F508del&#47;G551D tratados con ivacaftor mostraron en la vida real mejor&#237;a de la funci&#243;n pulmonar&#44; el estado nutricional&#44; las exacerbaciones respiratorias&#44; los aislamientos de <span class="elsevierStyleItalic">P&#46; aeruginosa</span> y la dosis de enzimas pancre&#225;ticas&#46;</p></span>"
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          0 => array:2 [
            "identificador" => "abst0005"
            "titulo" => "Introducci&#243;n"
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          1 => array:2 [
            "identificador" => "abst0010"
            "titulo" => "M&#233;todos"
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introduction</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Ivacaftor is a cystic fibrosis transmembrane conductance regulator &#40;CFTR&#41; potentiator that has been shown to improve the nutritional status and lung function of cystic fibrosis patients with the G551D mutation in clinical trials&#46; The objective of this study was to describe the real-world progress of children receiving ivacaftor&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Methods</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">We describe the real-world progress of four children with cystic fibrosis and the F508del&#47;G551D genotype comparing data during ivacaftor treatment with baseline and with the year before commencing treatment&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Results</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Our sample comprised 4 children aged between 6 and 14 years and including one with a recent diagnosis of CF and other with persistent <span class="elsevierStyleItalic">Mycobacterium abscessus &#40;M&#46; abscessus&#41;</span> and recurrent allergic bronchopulmonary aspergillosis&#46; The baseline FEV1 was 58&#46;5&#37; to 81&#46;8&#37; of the predicted value&#44; and ivacaftor was taken for a mean 24 months &#40;range&#44; 12-30 months&#41;&#46; All patients experienced a significant and sustained improvement in lung function&#46; Compared to baseline&#44; the weight <span class="elsevierStyleItalic">z</span>-score improved by 1&#46;53 points&#44; and the BMI <span class="elsevierStyleItalic">z</span>-score by 1&#46;6 points&#46; Compared to the year before starting ivacaftor&#44; the frequency of <span class="elsevierStyleItalic">Pseudomonas aeruginosa &#40;P&#46; aeruginosa&#41;</span> isolates decreased &#40;&#8722;0&#46;4&#47;patient&#47;year&#41;&#44; as did the number of respiratory exacerbations &#40;&#8722;1&#46;8&#47;patient&#47;year&#41;&#46; The weight-adjusted dose of lipase per kilogram decreased progressively in all patients&#46; In 1 patient&#44; a previously persistent <span class="elsevierStyleItalic">M&#46; abscessus</span> infection and recurrent allergic bronchopulmonary aspergillosis resolved during treatment&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusions</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Children with cystic fibrosis and the F508del&#47;G551D genotype receiving treatment with ivacaftor experienced a real-world improvement in lung function&#44; nutritional status&#44; respiratory exacerbations&#44; isolation of <span class="elsevierStyleItalic">P&#46; aeruginosa</span>&#44; and dose of pancreatic enzymes&#46;</p></span>"
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Paciente 1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Paciente 2&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">Sexo&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">Var&#243;n&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">Mujer&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">Edad al diagn&#243;stico&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">2 a&#241;os&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">2 meses&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">2 a&#241;os&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">13 a&#241;os&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Cloro en sudor al diagn&#243;stico&#44; mmol&#47;l&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">126&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">96&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">99&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">90&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">Genotipo&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">F508del&#47;G551D&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">F508del&#47;G551D&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">F508del&#47;G551D&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">Insuficiencia pancre&#225;tica&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">S&#237;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">S&#237;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">S&#237;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">S&#237;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Edad al inicio de ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">10 a&#241;os&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">7 a&#241;os&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">6 a&#241;os&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">14 a&#241;os&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Duraci&#243;n de tratamiento con ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">30 meses&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">30 meses&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">24 meses&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">12 meses&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Microrganismos detectados al inicio de ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Mycobacterium abscessus</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">No&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">No&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">No&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">N&#250;mero de aislamientos de <span class="elsevierStyleItalic">Pseudomonas aeruginosa</span> en el a&#241;o previo al tratamiento con ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Sin datos&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">A&#241;o previo&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">0-6 meses de ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">7-12 meses de ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">13-18 meses de ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">19-24 meses de ivacaftor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
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                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&#218;ltima espirometr&#237;a&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " colspan="9" align="left" valign="\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Paciente 1</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>N&#250;mero de espirometr&#237;as&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">10&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>FEV<span class="elsevierStyleInf">1</span> &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">64&#44;7 &#40;10&#44;8&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">63&#44;9&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">60&#44;7 &#40;5&#44;6&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">70&#44;4 &#40;15&#44;6&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">81&#44;3 &#40;4&#44;0&#41;<a class="elsevierStyleCrossRef" href="#tblfn0005">&#42;</a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">77&#44;2 &#40;2&#44;0&#41;<a class="elsevierStyleCrossRef" href="#tblfn0005">&#42;</a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">76&#44;8 &#40;1&#44;5&#41;<a class="elsevierStyleCrossRef" href="#tblfn0005">&#42;</a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">78&#44;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>FVC &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">85&#44;9 &#40;5&#44;6&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">86&#44;3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">88&#44;4 &#40;6&#44;6&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">86&#44;2 &#40;7&#44;4&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">77&#44;8 &#40;5&#44;8&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">78&#44;0 &#40;3&#44;3&#41;<a class="elsevierStyleCrossRef" href="#tblfn0005">&#42;</a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">76&#44;4 &#40;2&#44;0&#41;<a class="elsevierStyleCrossRef" href="#tblfn0005">&#42;</a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">77&#44;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>FEF<span class="elsevierStyleInf">25-50</span> &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">29&#44;7 &#40;14&#44;1&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Paciente 3</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>N&#250;mero de espirometr&#237;as&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>FEV<span class="elsevierStyleInf">1</span> &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>FVC &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>FEF<span class="elsevierStyleInf">25-50</span> &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>FEV<span class="elsevierStyleInf">1</span>&#47;FVC&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " colspan="9" align="left" valign="\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Paciente 4</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>N&#250;mero de espirometr&#237;as&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">3&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>FEV<span class="elsevierStyleInf">1</span> &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>FVC &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">110 &#40;11&#44;3&#41;&nbsp;\t\t\t\t\t\t\n
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          "leyenda" => "<p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">IMC&#58; &#237;ndice de masa corporal&#46;</p><p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">Datos expresados como frecuencias absolutas o media &#40;DE&#41;&#46;</p><p id="spar0085" class="elsevierStyleSimplePara elsevierViewall">La significaci&#243;n estad&#237;stica se calcul&#243; con respecto al a&#241;o previo a iniciarse el tratamiento&#58;</p>"
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          "es" => "<p id="spar0090" class="elsevierStyleSimplePara elsevierViewall">Valores de cloro en sudor &#40;mmol&#47;l&#41; antes del inicio y durante el tratamiento con ivacaftor</p>"
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