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Azitromicina a largo plazo en niños con fibrosis quística: un ensayo cruzado aleatorizado, controlado con placebo y
A Equi1, I M Balfour-Lynn, A Bush
1Department of Paediatric Respiratory Medicine, Royal Brompton Hospital, London, UK.
Lancet (London, England)
|October 18, 2002
Resumen
La azitromicina mostró un beneficio modesto en la función pulmonar en niños con fibrosis quística. Este antibiótico puede reducir la necesidad de cursos de antibióticos orales en pacientes con FQ.
Área de la Ciencia:
- Pulmonología Pulmonología.
- La pediatría es la medicina de los niños.
- Farmacología Farmacología.
Sus antecedentes:
- La azitromicina, un antibiótico macrólido, posee propiedades antiinflamatorias.
- Los estudios piloto sugirieron posibles beneficios clínicos de la azitromicina en la fibrosis quística (FQ).
Objetivo del estudio:
- Evaluar formalmente la eficacia de la azitromicina en niños con fibrosis quística.
Principales métodos:
- Un ensayo cruzado aleatorizado, doble ciego y controlado con placebo de 15 meses que involucró a 41 niños con FQ (entre 8 y 18 años).
- Los pacientes recibieron azitromicina o placebo durante 6 meses, seguido de un lavado de 2 meses y luego cruzaron.
- El resultado primario fue la diferencia relativa en el volumen expiratorio forzado en 1 segundo (FEV1); los resultados secundarios incluyeron marcadores inflamatorios, pruebas de ejercicio y uso de antibióticos.
Principales resultados:
- Una mediana de la diferencia relativa en el FEV1 de 5.4% en favor de la azitromicina (p=0.059).
- Se necesitaron significativamente menos ciclos de antibióticos orales en el grupo de azitromicina (p=0,005).
- No se observaron cambios significativos en los marcadores inflamatorios, la tolerancia al ejercicio o el bienestar subjetivo.
Conclusiones:
- Se justifica un ensayo de 4-6 meses de azitromicina para los niños con FQ que no responden a las terapias convencionales.
- El mecanismo preciso del beneficio de la azitromicina en la FQ sigue siendo indeterminado.
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