目的系统评价左乙拉西坦添加治疗成人难治性癫痫部分性发作的有效性及安全性。方法检索Medline、Em Base、Cochrane Library、中国知网(CNKI)、中国生物医学文献(CBM)、万方、维普等数据库中公开发表的左乙拉西坦添加治疗成人难治性癫痫部分性发作的随机对照研究,对符合纳入标准的文献进行偏倚风险评价,并用Rev Man 5.3软件进行Meta分析。结果共纳入7项随机对照研究,共748例患者,其中,左乙拉西坦治疗组为试验组,共426例,安慰剂组为对照组,共322例。试验组添加左乙拉西坦治疗12~14周后,有效率和完全控制率均显著高于对照组(P〈0.05),无效率低于对照组(P〈0.05)。2组的保留率及主要药物不良反应的发生率差异无统计学意义(P〉0.05)。结论左乙拉西坦治疗成人难治性癫痫部分性发作,临床疗效优于对照组,耐受性及安全性良好。
Objective To evaluate the efficacy and safety of levetiracetam( LEV) adjunctive treatment for adult patients with refractory partial- onset seizures. Methods Published randomized controlled trials( RCTs) focusing on LEV add- on in treating adult patients with refractory partial- onset seizures were searched from Medline,Em Base,Cochrane Library,CNKI,CBM,Wanfang and VIP databases. Meta- analysis was conducted by Rev Man 5. 3 software. Results Seven RCTs involving748 participants were included. There were 426 participants in LEV treatment group and 322 participants in placebo control group. The results of Meta- analysis revealed that the rate of 50% and 100% responders were significantly higher in treatment group compared with that in control group,while the rate of non- responders were lower in treatment group. No significant differences were detected between treatment and control groups in retention rate and main adverse reaction rate.Conclusion LEV adjunctive treatment,with good tolerance and safety,is more effective in treating adults with refractory partial- onset seizures compared to placebo.