Stiripentol in severe myoclonic epilepsy in infancy: a randomised placebo-controlled syndrome-dedicated trial
Stiripentol in severe myoclonic epilepsy in infancy: a randomised placebo-controlled syndrome-dedicated trial
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DOI：
10.1016/s0140-6736(00)03157-3
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发表时间：
2000-11-11
期刊：
影响因子：
168.9
通讯作者：
Pons, G
中科院分区：
文献类型：
--
作者：
Chiron, C;Marchand, MC;Pons, G
背景斯替戊醇是一种细胞色素P450抑制剂，在一项开放性研究中与氯巴占和丙戊酸盐联合治疗婴儿期重度肌阵挛性癫痫（SMEI）显示出抗癫痫疗效。为了证实这些结果，41名儿童与SMEI被列入一个随机的，安慰剂对照，add-on trial.Methods基线期1个月后，安慰剂（n=20）或司替戊醇（n=21），在一个双盲期2个月内，加入到丙戊酸盐和氯巴占。然后患者以开放方式接受司替戊醇。反应者被定义为阵挛频率减少50%以上结果15例（71%）患者对司替戊醇有反应（包括9例无阵挛或强直阵挛发作），而安慰剂组只有1例（5%）（均未出现癫痫发作;司替戊醇95% CI 52.1-90.7 vs安慰剂0-14.6）。差异的95% CI为42.2-85.7。司替戊醇组较基线的变化百分比（-69%）高于安慰剂组（+7%），p
Background Stiripentol is an inhibitor of cytochrome P450 that showed antiepileptic efficacy in severe myoclonic epilepsy in infancy (SMEI) in association with clobazam and valproate in an open study. To confirm these results, 41 children with SMEI were included in a randomised, placebo-controlled, add-on trial.Methods After a baseline period of 1 month, placebo (n=20) or stiripentol (n=21) was added to valproate and clobazam during a double-blind period of 2 months. Patients then received stiripentol in an open fashion. Responders were defined as having more than 50% reduction in the frequency of clonic (or tonic-clonic) seizures during the second month of the double-blind period compared with baseline.Findings 15 (71%) patients were responders on stiripentol (including nine free of clonic or tonic-clonic seizures), whereas there was only one (5%) on placebo (none were seizure free; stiripentol 95% CI 52.1-90.7 vs placebo 0-14.6). The 95% CI of the difference was 42.2-85.7. Percentage of change from baseline was higher on stiripentol (-69%) than on placebo (+7%), p