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        "resumen" => "<span class="elsevierStyleSectionTitle">Objetivos</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Comparar la eficacia y evaluar la bioequivalencia cl&#237;nica de dos presentaciones de ibuprofeno para ni&#241;os&#44; suspensi&#243;n y gr&#225;nulos efervescentes&#44; en el tratamiento de la fiebre&#46;</p> <span class="elsevierStyleSectionTitle">M&#233;todos</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Ensayo cl&#237;nico abierto&#44; de distribuci&#243;n aleatoria y multic&#233;ntrico&#46; Se administr&#243; a ni&#241;os con pesos superiores a 25 kg&#44; que acudieron con temperatura axilar superior a 38 &#176;C a servicios de urgencias hospitalarios&#44; una dosis de ibuprofeno en suspensi&#243;n de 7 mg&#47;kg&#44; o una dosis de gr&#225;nulos efervescentes con la siguiente posolog&#237;a&#58; 200 mg en ni&#241;os con pesos entre 25 y 40 kg&#44; o 400 mg si pesaban entre 35 y 40 kg y ten&#237;an una temperatura axilar superior a 39 &#176;C&#44; as&#237; como en los ni&#241;os de m&#225;s de 40 kg&#46; Se tom&#243; la temperatura axilar antes del tratamiento y a los 30&#44; 60&#44; 90&#44; 120&#44; 180 y 240 min&#44; y se registraron posibles efectos adversos&#46;</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Se incluyeron 103 pacientes&#44; 51 recibieron gr&#225;nulos y 52 suspensi&#243;n&#46; La temperatura media se redujo en los dos grupos a lo largo del estudio &#40;p&#44; 0&#44;005&#41;&#44; sin diferencias entre ellos&#46; Las diferencias medias de temperatura en cada momento del estudio se situ&#243; dentro del intervalo de bioequivalencia &#40;6 0&#44;5 &#176;C&#41;&#46; En un caso se alcanz&#243; una temperatura axilar de 35&#44;9 &#176;C&#44; siendo el &#250;nico acontecimiento adverso ocurrido&#46;</p> <span class="elsevierStyleSectionTitle">Conclusiones</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Ambas formulaciones se mostraron eficaces en la reducci&#243;n de la temperatura y pueden considerarse bioequivalentes cl&#237;nicamente&#46;</p>"
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        "resumen" => "<span class="elsevierStyleSectionTitle">Objectives</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">To compare the efficacy and to evaluate the clinical bioequivalence of two different formulations of ibuprofen &#40;suspension and effervescent granules&#41; in febrile children&#46;</p> <span class="elsevierStyleSectionTitle">Methods</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">An open&#44; randomized&#44; multicenter study&#46; Febrile children &#40;axillary temperature 38 &#176;C&#41; weighing more than 25 kg&#44; admitted into the emergency departments of the participating hospitals were randomly assigned to either of the two treatment groups&#58; ibuprofen suspension &#40;7 mg&#47;kg&#41; or effervescent granules at the following dosages&#58; 200 mg in children weighing 25-40 kg or 400 mg in children weighing 35-40 kg and with an axillary temperature above 39 &#176;C&#46; This latter dose of 400 mg was also given to children weighing more than 40 kg&#46;</p><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">The investigators took axillary temperature before treatment and 30&#44; 60&#44; 90&#44; 120&#44; 180 and 240 min after administration of the corresponding dose&#46; Possible adverse events were noted&#46;</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">A total of 103 patients were included in the study&#59; 51 received the effervescent granules and 52 received the suspension formulation&#46; The mean temperature was reduced in both groups during the study &#40;p&#44; 0&#46;005&#41;&#46; No differences were found between the formulations&#46; The mean differences of temperatures at each point of the study were within the clinical bioequivalence interval &#40;6 0&#46;5 &#176;C&#41;&#46; Only one patient had an axillary temperature of 35&#46;9 &#176;C&#46; This was the only adverse event recorded in the study&#46;</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Both ibuprofen formulations were effective in reducing fever and may be considered clinically bioequivalent&#46;</p>"
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Vol. 53. Núm. 5.
Páginas 436-440 (noviembre 2000)
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Vol. 53. Núm. 5.
Páginas 436-440 (noviembre 2000)
Acceso a texto completo
Evaluación de la eficacia antipirética y seguridad de dos formulaciones pediátricas de ibuprofeno
Evaluation of the antipyretic safety and accuracy of two pediatric ibuprofen formulations
Visitas
8752
J. Díez Domingoa,
Autor para correspondencia
diez_jav@gva.es

Correspondencia: Dr. J. Díez Domingo. Centro de Salud Nazaret. Parque, 7. 46024 Valencia.
, M.V. Planelles Cantarinob, F. Moreno Madridc, J. Uberos Fernándezd, J. Moreno Martíne, A. Molina Carballof, J. Antelo Cortizasg, S. Armenteros Gonzálezh, R. Domínguez Granadosh, E. Moreno Carreteroh
a Centro de Salud de Nazaret. Valencia
b Servicio de Urgencias de Pediatría. Hospital Clínico de Valencia. Servicios de Pediatría
c Hospital General Básico de Baza
d Hospital General Básico de Motril
e Hospital Virgen de las Nieves
f Hospital Clínico San Cecilio. Granada
g Servicio de Pediatría Hospital Xeral Cíes de Vigo. Pontevedra
h Departamento Médico. Laboratorios Knoll, S.A. Madrid
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Resumen
Bibliografía
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Estadísticas
Abstract
Objetivos

Comparar la eficacia y evaluar la bioequivalencia clínica de dos presentaciones de ibuprofeno para niños, suspensión y gránulos efervescentes, en el tratamiento de la fiebre.

Métodos

Ensayo clínico abierto, de distribución aleatoria y multicéntrico. Se administró a niños con pesos superiores a 25 kg, que acudieron con temperatura axilar superior a 38 °C a servicios de urgencias hospitalarios, una dosis de ibuprofeno en suspensión de 7 mg/kg, o una dosis de gránulos efervescentes con la siguiente posología: 200 mg en niños con pesos entre 25 y 40 kg, o 400 mg si pesaban entre 35 y 40 kg y tenían una temperatura axilar superior a 39 °C, así como en los niños de más de 40 kg. Se tomó la temperatura axilar antes del tratamiento y a los 30, 60, 90, 120, 180 y 240 min, y se registraron posibles efectos adversos.

Resultados

Se incluyeron 103 pacientes, 51 recibieron gránulos y 52 suspensión. La temperatura media se redujo en los dos grupos a lo largo del estudio (p, 0,005), sin diferencias entre ellos. Las diferencias medias de temperatura en cada momento del estudio se situó dentro del intervalo de bioequivalencia (6 0,5 °C). En un caso se alcanzó una temperatura axilar de 35,9 °C, siendo el único acontecimiento adverso ocurrido.

Conclusiones

Ambas formulaciones se mostraron eficaces en la reducción de la temperatura y pueden considerarse bioequivalentes clínicamente.

Key words:
Ibuprofen
Bioequivalence
Fever
Resumen
Objectives

To compare the efficacy and to evaluate the clinical bioequivalence of two different formulations of ibuprofen (suspension and effervescent granules) in febrile children.

Methods

An open, randomized, multicenter study. Febrile children (axillary temperature 38 °C) weighing more than 25 kg, admitted into the emergency departments of the participating hospitals were randomly assigned to either of the two treatment groups: ibuprofen suspension (7 mg/kg) or effervescent granules at the following dosages: 200 mg in children weighing 25-40 kg or 400 mg in children weighing 35-40 kg and with an axillary temperature above 39 °C. This latter dose of 400 mg was also given to children weighing more than 40 kg.

The investigators took axillary temperature before treatment and 30, 60, 90, 120, 180 and 240 min after administration of the corresponding dose. Possible adverse events were noted.

Results

A total of 103 patients were included in the study; 51 received the effervescent granules and 52 received the suspension formulation. The mean temperature was reduced in both groups during the study (p, 0.005). No differences were found between the formulations. The mean differences of temperatures at each point of the study were within the clinical bioequivalence interval (6 0.5 °C). Only one patient had an axillary temperature of 35.9 °C. This was the only adverse event recorded in the study.

Conclusions

Both ibuprofen formulations were effective in reducing fever and may be considered clinically bioequivalent.

Palabras clave:
Ibuprofeno
Bioequivalencia
Fiebre
El Texto completo está disponible en PDF
Bibliografía
[1]
S.M. Lesko, A.A. Mitchell.
An assessment of the safety of pediatric ibuprofen. A practitioner based randomized clinical trial.
JAMA, 273 (1995), pp. 929-933
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Ibuprofen prophylaxis for adverse reactions to Diphteria-Tetanus-Pertussis vaccination: A randomized trial.
Curr Ther Res, 59 (1998), pp. 579-588
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Am J Emer Med, 6 (1988), pp. 104-107
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Comparison of multidose ibuprofen and acetaminophen therapy in febrile children.
Am J Dis Child, 146 (1992), pp. 626-632
[6]
G. Wilson, A.J.M.S. Guerra, N.T. Santos.
Comparative study of the antipyretic effect of ibuprofen (oral suspension) and paracetamol (suppositories) in paediatrics.
J Int Med Res, 12 (1984), pp. 46-49
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Am J Dis Child, 146 (1992), pp. 622-625
[8]
E. Autret, J. Reboul-Marty, B. Henry-Launois, C. Laborde, S. Courcier, J.M. Goehrs, et al.
Evaluation of ibuprofen versus aspirin and paracetamol on efficacy and comfort in children with fever.
Eur J Clin Pharmacol, 51 (1997), pp. 367-371
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31.ª ed, Martindale, (1996),

Trabajo financiado por Laboratorios Knoll, S.A. (BR002).

Copyright © 2000. Asociación Española de Pediatría
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