ABSTRACT
BACKGROUND: The long-term efficacy of corticosteroids to prevent atopic dermatitis (AD) relapses has partially been addressed in children. This study compared an intermittent dosing regimen of fluticasone propionate (FP) cream 0.05% with its vehicle base in reducing the risk of relapse in children with stabilized AD. METHODS: A randomized controlled, multicentric, double-blind trial was conducted. Children (2-10 years) with mild/moderate AD (exclusion criteria: >30% affected body surface area and/or head) were enrolled into an Open-label Stabilization Phase (OSP) of up to 2 weeks on twice daily FP. Those who achieved treatment success entered the Double-blind Maintenance Phase (DMP). They were randomly allocated to receive FP or vehicle twice-weekly on consecutive days for 16 weeks. The primary study endpoint was relapse rate; time to relapse and severity of disease were also studied. Kaplan-Meier estimates were calculated. RESULTS: Fifty-four patients (29 girls) entered the OSP (23 mild AD) and 49 (26 girls) continued into the DMP. Mean age was 5.5 (SD: 2.8) and 5.1 (SD: 2.3) yrs for FP and vehicle groups, respectively. Four patients withdrew from the DMP (two in every group). Patients treated with FP twice weekly had a 2.7 fold lower risk of experiencing a relapse than patients treated with vehicle (relative risk 2.72, SD: 1.28; p = 0.034). FP was also superior to vehicle for delaying time to relapse. Both treatment therapies were well tolerated. CONCLUSION: This long-term study shows that twice weekly FP provides an effective maintenance treatment to control the risk of relapse in children with AD
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Subject(s)
Humans , Male , Female , Child, Preschool , Child , Anti-Inflammatory Agents/therapeutic use , Dermatitis, Atopic/drug therapy , Fluticasone/therapeutic use , Secondary Prevention/methods , Double-Blind MethodABSTRACT
OBJETIVO: 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 25kg, que acudieron con temperatura axilar superior a38º 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 ºC, 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 (60,5ºC). En un caso se alcanzó una temperatura axilar de 35,9 ºC, siendo el único acontecimiento adverso ocurrido. CONCLUSIÓN: Ambas formulaciones se mostraron eficaces en la reducción de la temperatura y pueden considerarse bioequivalentes clínicamente (AU)
