Montelukast para el asma crónica en niños de 6 a 14 años: un ensayo aleatorizado, doble ciego. El grupo de estudio de Montelukast pediátrico
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B Knorr1, J Matz, J A Bernstein
1Department of Pulmonary-Immunology, Merck Research Laboratories, Rahway, NJ 07065, USA.
JAMA
|April 29, 1998
Resumen
Montelukast mejoró significativamente la función pulmonar en niños con asma. Este estudio muestra montelukast es un tratamiento eficaz para el asma pediátrica, la mejora de la mañana FEV1 en pacientes jóvenes.
Área de la Ciencia:
- Pulmonología Pediátrica.
- Farmacología Farmacología.
- Los ensayos clínicos son ensayos clínicos.
Sus antecedentes:
- Los leucotrienos son mediadores clave en el asma, causando broncoconstricción y inflamación de las vías respiratorias.
- Estudios previos mostraron que los bloqueadores de leucotrieno benefician a adultos y adolescentes con asma.
- Los niños menores de 12 años, un grupo demográfico con alta prevalencia de asma, carecían de estudios dirigidos.
Objetivo del estudio:
- Para evaluar la eficacia clínica de montelukast, un antagonista del receptor de leucotrieno.
- Evaluar el efecto de montelukast en la función pulmonar en niños de 6 a 14 años con asma.
Principales métodos:
- Un estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo de 8 semanas.
- Participaron 336 niños (6-14 años) con asma de moderada a grave.
- Los pacientes recibieron 5 mg de montelukast o placebo al día, con el FEV1 matutino como resultado primario.
Principales resultados:
- El grupo de Montelukast mostró un aumento del 8,23% en el FEV1 matutino desde el inicio.
- El grupo de placebo mostró un aumento del 3,58% en el FEV1 matutino desde el inicio.
- La diferencia entre los grupos fue estadísticamente significativa (P<.001).
Conclusiones:
- Montelukast mejora efectivamente el FEV1 matutino en niños de 6 a 14 años con asma crónica.
- Este estudio apoya montelukast como una opción de tratamiento viable para el manejo de asma pediátrica.
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