Terapia inmunosupresora en síndrome de opsoclonus-mioclonus ataxia asociado a un neuroblastoma paravertebral / Immunosuppressive therapy in opsoclonus-myoclonus ataxia syndrome associated with paravertebral neuroblastoma

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Estudio abierto aleatorio y comparativo de la monoterapia con topiramato frente a carbamacepina en el tratamiento de pacientes pediátricos con epilepsia de reciente diagnóstico / A randomised open trial comparing monotherapy with topiramate versus carbamazepine in the treatment of paediatric patients with recently diagnosed epilepsy

Introducción. Se conocen estudios que han mostrado la eficacia del topiramato (TPM) en niños con epilepsia. Objetivo. Demostrar la eficacia, tolerabilidad y seguridad de TPM como monoterapia en niños con epilepsia parcial de reciente diagnóstico y compararlo con la carbamacepina (CBZ). Pacientes y métodos. Se realizó un estudio multicéntrico, abierto, comparativo, aleatorizado, en epilepsia parcial con o sin generalización secundaria, y se asignó a un grupo de tratamiento: TPM o CBZ. Se excluyeron los pacientes con enfermedades degenerativas. Los datos se analizaron mediante el paquete informático SPSS versión 11.0 con estadística no paramétrica. Para comparaciones entre grupos se empleó la 2 en caso de variables cualitativas y la t de Student en el caso de las cuantitativas. Resultados. Se incluyeron 88 pacientes, 33 en el grupo 1 (TPM) y 32 en el grupo 2 (CBZ). Abandonaron el estudio por eventos adversos o pérdidas en el seguimiento 23 (13 del grupo 1 y 10 del grupo 2). Ambos grupos presentaron una disminución del número de crisis; sin embargo, en los meses 6 y 9 de seguimiento, la diferencia entre los grupos fue estadísticamente significativa a favor del TPM (p = 0,01, t de Student). El porcentaje de pacientes libres de crisis fue mayor en el grupo 1 que en el 2, (p = 0,02, 2). Los eventos adversos más frecuentes fueron: somnolencia (9 por ciento) y pérdida de peso (6 por ciento) en el grupo 1, y somnolencia (19 por ciento), mareo (3 por ciento) y descontrol de crisis (3 por ciento) en el grupo 2. Conclusiones. Se observó en ambos grupos buena eficacia y escasos eventos adversos. El TPM es una buena alternativa como tratamiento de la epilepsia en niños de reciente diagnóstico comparado con el tratamiento de referencia (AU)

Introduction. In some studies in children, topiramate showed efficacy. Aim. To evaluate efficacy, tolerability and safety of topiramate in monotherapy in newly diagnosed epilepsy vs carbamazepine in children. Patients and methods. In a multicentre, open-label, comparative and randomized study patients with partial epilepsy, were randomized to received topiramate or carbamazepine treatment. Patients with degenerative disease were excluded. Data were analysed by SPSS statistical program v. 11.0, and non parametric test. Comparisons between groups were made with chi square test and t Student’s test. Results. In total were included 88 patients, 33 in group 1 (topiramate), 32 group 2 (carbamazepine), 23 were drop-outs because adverse events and lost in follow-up (13 in group 1 y 10 group 2). In both groups were observed good efficacy, in month 6 and 9 of follow-up, the average of seizures in group 1 were better than group 2 (p = 0.01, t Student’s test). The percentage of free seizure patients was greater in group 1 than group 2 (statistical significance p = 0.02, chi square test). The adverse events were similar in both groups and mild, somnolence 9%, weight loss 6% in group 1 and somnolence 19%, dizziness 3% and seizure discontrol 3% in group 2. Conclusions. Good efficacy in both groups, and topiramate in good treatment choice in newly diagnosed epilepsy in children because it’s the efficacy and tolerability in comparison with the gold standard carbamazepine (AU)

[A randomised open trial comparing monotherapy with topiramate versus carbamazepine in the treatment of paediatric patients with recently diagnosed epilepsy]. / Estudio abierto aleatorio y comparativo de monoterapia con topiramato frente a carbamacepina en el tratamiento de pacientes pediátricos con epilepsia de reciente diagnóstico.

INTRODUCTION: In some studies in children, topiramate showed efficacy. AIM: To evaluate efficacy, tolerability and safety of topiramate in monotherapy in newly diagnosed epilepsy vs carbamazepine in children. PATIENTS AND METHODS: In a multicentre, open-label, comparative and randomized study patients with partial epilepsy, were randomized to received topiramate or carbamazepine treatment. Patients with degenerative disease were excluded. Data were analysed by SPSS statistical program v. 11.0, and non parametric test. Comparisons between groups were made with chi square test and t Student's test. RESULTS: In total were included 88 patients, 33 in group 1 (topiramate), 32 group 2 (carbamazepine), 23 were drop-outs because adverse events and lost in follow-up (13 in group 1 y 10 group 2). In both groups were observed good efficacy, in month 6 and 9 of follow-up, the average of seizures in group 1 were better than group 2 (p = 0.01, t Student's test). The percentage of free seizure patients was greater in group 1 than group 2 (statistical significance p = 0.02 chi square test). The adverse events were similar in both groups and mild, somnolence 9%, weight loss 6% in group 1 and somnolence 19%, dizziness 3% and seizure discontrol 3% in group 2. CONCLUSIONS: Good efficacy in both groups, and topiramate in good treatment choice in newly diagnosed epilepsy in children because it's the efficacy and tolerability in comparison with the gold standard carbamazepine.