吡仑帕奈治疗难治性癫痫部分发作的Meta分析

Meta-analysis of efficacy and safety of perampanel in treatment of refractory partial-onset seizures

目的系统评价吡仑帕奈治疗难治性癫痫部分发作的有效性与安全性。方法计算机检索Pub Med、EBSCO、EMbase、Cochrane Library、中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)和万方数据库,收集吡仑帕奈治疗难治性癫痫部分发作的随机对照试验,检索时限从建库至2017年2月,采用Rev Man 5.0软件对各效应指标进行Meta分析。结果共纳入5项研究,计1 500例患者。Meta分析结果显示:吡仑帕奈组癫痫完全不发作率[OR=3.75,95%CI(1.77,7.93),P=0.000 6]、发作频率减少≥50%的患者百分率[OR=2.08,95%CI(1.69,2.56),P<0.001]均高于安慰剂组,差异有统计学意义;吡仑帕奈主要不良反应有眩晕、困倦、头痛、共济失调、鼻咽炎等;吡仑帕奈8 mg和12 mg组总不良反应发生率高于安慰剂组,差异有统计学意义(P<0.05)。结论吡仑帕奈治疗难治性癫痫部分发作能有效减少癫痫发作频率,且不良反应较轻,患者基本耐受。

Objective o evaluate the efficacy and safety ofperampanel in the treatment of refractory partial-onset seizures. Methods The randomized controlled trials ofperampanel in treatment of refractory partial-onset seizures were searched from PubMed, EBSCO, EMbase, Cochrane Library, CBM, CNKI, VIP database, and Wanfang database by computer. Data were collected from establishment of the database to February 2017 and the each index was analyzed by met,a-analysis with RevMan 5.0 software. Results Five RCT were included, including 1 500 patients with refractory partial-onset seizures. Meta-analysis results showed that there was a significant difference between perampanel and placebo in term of seizure-free rate [OR=3.75, 95%CI（1.77, 7.93）, P = 0.000 6] and percentage of patients achieving 50% reduction in seizure frequency [OR=2.08, 95%CI（1.69, 2.56）, P 〈 0.001]. Common adverse reactions of perarnpanel were dizziness, somnolence, headache, ataxia, nasopharyngitis, etc. The total rate of adverse reactions of the two Perampanel groups of 8 mg group and 12 mg group doses were higher than placebo group （P 〈 0.05）. Conclusion The clinical efficacy ofperampanel in the treatment of refractory partial-onset seizures, and the adverse reactions is slight, patient is well tolerated.