RESUMEN
Objetivo: Obtener un estimador de la eficacia del racecadotrilo en el tratamiento de la diarrea aguda mediante revisión sistemática y metaanálisis. Material y métodos: Se seleccionaron ensayos clínicos de calidad realizados en niños en los que se compara la eficacia del racecadotrilo frente a placebo en cuanto a duración de los síntomas, cantidad de deposiciones y efectos secundarios. La búsqueda se ha realizado en bases electrónicas (Med-line, EMBASE, CENTRAL, CINAHL, mRCT, Pascal), en las referencias de los artículos recuperados y mediante contacto con el fabricante, hasta diciembre de 2007. Dos evaluadores independientes han evaluado la calidad. Resultados: Se seleccionaron dos ensayos de muestra pequeña (135 y 172 niños, todos hospitalizados) y de calidad media. Éstos incluyen a niños de edades comprendidas entre 3 meses y 4 años con diarrea aguda de menos de 5 días de evolución a quienes al tratamiento habitual se añade racecadotrilo o placebo. No existen diferencias en la proporción de niños enfermos al quinto día (riesgo relativo [RR] = 0,73; intervalo de confianza [IC] del 95 %, 0,29-1,81). Se demuestra una eficacia leve en el volumen de las deposiciones en las primeras 48 h (diferencia estandarizada de medias [DEM] = -0,65; IC 95 %, -0,88 a -0,42). No se observan diferencias en los efectos secundarios (vómitos, RR = 1,16; IC 95 %, 0,64-2,12). Conclusión: La proporción de curados al quinto día no mejora añadiendo racecadotrilo al tratamiento habitual, si bien disminuye el volumen de deposiciones en las primeras 48 h. Sería interesante estudiar la eficacia en atención primaria valorando el número y volumen de las deposiciones y la duración y número de ingresos (AU)
Objective: To estimate, through a systematic review of the literature, the efficacy of racecadotril in the treatment of acute diarrhoea. Material and methods: Randomised trials carried out in children comparing racecadotril with placebo in terms of diarrhoea recovery, stools output and adverse effects were selected. Electronic databases (Medline, EMBASE, CENTRAL, CINAHL, mRCT, Pascal) and bibliographies of retrieved articles were searched, and the drug developer was contacted. Two authors independently assessed the quality of the retrieved articles and extracted the data. Results: Two small sample size randomised trials (135 and 172 children) of moderate quality were selected. They included children with less than five days diarrhoea and aged between 3 months and 4 years. There was no difference in the proportion of children who recovered by day 5 (RR = 0.73, CI95 % 0.29 to 1.81), although the stools volume during the first 48 hours was less in the racecadotril group (SMD = -0.65, CI95 % -0.88 to -0.52). There is no difference in the risk of vomiting (RR = 1.16, CI95 % 0.64 to 2.12). Conclusion: The proportion of recoveries by the 5th day is the same, although the stool volumes during the first 48 hours are less in the racecadotril treated children. It would be interesting to study the efficacy in a primary care setting assessing the cure rate, the stool volumes and the admission rate to elucidate if there is room for this drug (AU)
Asunto(s)
Humanos , Masculino , Femenino , Niño , Antidiarreicos/uso terapéutico , Diarrea/diagnóstico , Diarrea/tratamiento farmacológico , Diarrea/epidemiología , Vómitos/complicaciones , Vómitos/diagnóstico , Antidiarreicos/administración & dosificación , Infecciones por Rotavirus/tratamiento farmacológico , Infecciones por Rotavirus/prevención & control , Rotavirus/inmunología , Rotavirus/aislamiento & purificación , Rotavirus/patogenicidadRESUMEN
OBJECTIVE: To estimate, through a systematic review of the literature, the efficacy of racecadotril in the treatment of acute diarrhoea. MATERIAL AND METHODS: Randomised trials carried out in children comparing racecadotril with placebo in terms of diarrhoea recovery, stools output and adverse effects were selected. Electronic databases (Medline, EMBASE, CENTRAL, CINAHL, mRCT, Pascal) and bibliographies of retrieved articles were searched, and the drug developer was contacted. Two authors independently assessed the quality of the retrieved articles and extracted the data. RESULTS: Two small sample size randomised trials (135 and 172 children) of moderate quality were selected. They included children with less than five days diarrhoea and aged between 3 months and 4 years. There was no difference in the proportion of children who recovered by day 5 (RR=0.73, CI 95% 0.29 to 1.81), although the stools volume during the first 48 hours was less in the racecadotril group (SMD=-0.65, CI 95% -0.88 to -0.52). There is no difference in the risk of vomiting (RR=1.16, CI 95% 0.64 to 2.12). CONCLUSION: The proportion of recoveries by the 5th day is the same, although the stool volumes during the first 48 hours are less in the racecadotril treated children. It would be interesting to study the efficacy in a primary care setting assessing the cure rate, the stool volumes and the admission rate to elucidate if there is room for this drug.