Virginia Commonwealth University, Richmond, VA, USA.
Neurology. 2012 Oct 2;79(14):1482-9. doi: 10.1212/WNL.0b013e31826d5ec0. Epub 2012 Sep 5.
Due to the challenges inherent in performing clinical trials in children, a systematic review of published clinical trials was performed to determine whether the efficacy of antiepileptic drugs (AEDs) in adults can be used to predict the efficacy of AEDs in the pediatric population.
Medline/PubMed, EMBASE, and Cochrane library searches (1970-January 2010) were conducted for clinical trials of partial-onset seizures (POS) and primary generalized tonic-clonic seizures (PGTCS) in adults and in children <2 and 2-18 years. Independent epidemiologists used standardized search and study evaluation criteria to select eligible trials. Forest plots were used to investigate the relative strength of placebo-subtracted effect measures.
Among 30 adjunctive therapy POS trials in adults and children (2-18 years) that met evaluation criteria, effect measures were consistent between adults and children for gabapentin, lamotrigine, levetiracetam, oxcarbazepine, and topiramate. Placebo-subtracted median percent seizure reduction between baseline and treatment periods (ranging from 7.0% to 58.6% in adults and from 10.5% to 31.2% in children) was significant for 40/46 and 6/6 of the treatment groups studied. The ≥50% responder rate (ranging from 2.0% to 43.0% in adults and from 3.0% to 26.0% in children) was significant for 37/43 and 5/8 treatment groups. In children <2 years, an insufficient number of trials were eligible for analysis.
This systematic review supports the extrapolation of efficacy results in adults to predict a similar adjunctive treatment response in 2- to 18-year-old children with POS.
由于在儿童中进行临床试验存在固有挑战，因此对已发表的临床试验进行了系统评价，以确定抗癫痫药物（AED）在成人中的疗效是否可用于预测其在儿科人群中的疗效。
对 Medline/PubMed、EMBASE 和 Cochrane 图书馆（1970 年 1 月至 2010 年 1 月）进行了检索，以寻找成人和 <2 岁和 2-18 岁儿童部分性发作（POS）和原发性全面强直阵挛发作（PGTCS）的临床试验。独立的流行病学家使用标准化的搜索和研究评估标准来选择合格的试验。森林图用于研究安慰剂减去效应量的相对强度。
在符合评估标准的 30 项成人和儿童（2-18 岁）辅助治疗 POS 试验中，加巴喷丁、拉莫三嗪、左乙拉西坦、奥卡西平、托吡酯在成人和儿童中的疗效指标一致。基线至治疗期之间的安慰剂减去的中位数癫痫发作减少百分比（在成人中为 7.0%至 58.6%，在儿童中为 10.5%至 31.2%）在 46 个治疗组中的 40 个和 6 个治疗组中均有显著意义。≥50%的应答率（在成人中为 2.0%至 43.0%，在儿童中为 3.0%至 26.0%）在 43 个治疗组中的 37 个和 8 个治疗组中的 5 个中均有显著意义。在 <2 岁的儿童中，可用于分析的试验数量不足。
本系统评价支持将成人的疗效结果外推，以预测 2 至 18 岁儿童 POS 的辅助治疗反应相似。
