左乙拉西坦治疗儿童癫癎的系统评价

Levetiracetam therapy for childhood epilepsy: a systematic review

摘要:

目的：左乙拉西坦已经广泛应用于儿童癫癎的治疗中，但尚无高质量证据证明其安全性和有效性。本研究系统评价左乙拉西坦治疗儿童癫癎的有效性和安全性。方法：计算机检索Pubmed、 Embase、Cochrane数据库和中国生物医学文献光盘数据库、万方和维普中文数据库，检索时间截止2009年3月。纳入左乙拉西坦治疗儿童癫癎的随机和半随机试验，用meta分析方法对数据进行处理和系统评价。结果：纳入2个随机对照试验。一篇为左乙拉西坦（n=101）与安慰剂对照（n=91）添加治疗儿童难治性癫癎的多中心随机双盲试验，共198名患儿，左乙拉西坦和安慰剂发作完全缓解率分别为6.9%，1%（P<0.01）。与安慰剂组比较，左乙拉西坦治疗明显减少了癫癎发作频率（P<0.01）。另一篇为左乙拉西坦（n=21）与奥卡西平（n=18）单药治疗儿童中央颞区棘波癫癎随机对照试验。共39名患儿。左乙拉西坦和奥卡西平两组发作完全缓解率分别为90.5%，72.2%（P=0.410）。左乙拉西坦治疗相关副反应发生率与安慰剂组和奥卡西平两组差异无统计学意义。结论：目前证据表明，左乙拉西坦治疗儿童癫癎有效，但仍需更多实验数据支持。［中国当代儿科杂志，2010，12（2）：128-131］

Abstract:

OBJECTIVE: Levetiracetam has been widely used for childhood epilepsy, but there is no high quality evidence to support its use. This study performed a systematic review to evaluate the effectiveness and safety of levetiracetam therapy for childhood epilepsy. METHODS: The papers related to levetiracetam therapy for childhood epilepsy published up to March, 2009 were retrieved electronically from the PubMed, Embase, the Cochrane Library, Chinese Biomedical Database, Wanfang and Weipu Chinese Journals Full-text Database. The relevant papers on randomized control trials (RCTs) or quasi-RCTs were studied by meta analysis. RESULTS: Two papers that met the inclusion criteria were included. The first paper involved 198 patients, including 108 cases in the levetiracetam therapy group and 97 cases in the placebo group. Seven cases (6.9%) were seizurefree in the levetiracetam therapy group compared with 1 case (1%) in the placebo group (P<0.01) 14 weeks after treatment. Levetiracetam therapy decreased significantly the frequency of seizures compared with the placebo treatment. The second paper involved 39 patients, including 21 cases in the levetiracetam therapy group and 18 cases in the oxcarbazepine therapy group. Nineteen cases (90.5%) were seizure-free in the levetiracetam therapy group compared with 13 cases (72.2%) in the oxcarbazepine therapy group (P=0.410) during a follow-up of 12-24 months. The adverse effects in the levetiracetam therapy group were not significantly different from the placebo and the oxcarbazepine therapy groups. CONCLUSIONS: The current evidence shows that levetiracetam therapy is effective for childhood epilepsy. However, it needs to be proved by the multi-centre, large sample RCTs.［Chin J Contemp Pediatr, 2010, 12 (2):128-131］