左乙拉西坦添加治疗难治性部分性发作癫痫疗效的Meta分析  

Meta-analysis of adjunctive levetiracetam in refractory partial seizures

作　　者：张颖[1] 张雅西 李岱[3] 林慧慧[4] 宋毅军[5] 

机构地区：[1]天津师范大学计算机与信息工程学院,300384 [2]浙江省温州市中心医院神经内科,325000 [3]天津医科大学总医院高干病房,300052 [4]天津医科大学,七年制2006级300070 [5]天津医科大学总医院神经内科,300052

出　　处：《中国现代神经疾病杂志》2012年第5期542-551,共10页Chinese Journal of Contemporary Neurology and Neurosurgery

基　　金：国家自然科学基金资助项目(项目编号:91132722),国家自然科学基金资助项目(项目编号:81071044);天津市自然科学基金资助项目(项目编号:10JCYBJC13800);天津市高等学校科技发展基金项目(项目编号:20090123);天津医科大学新世纪人才支持计划资助项目~~

摘　　要：目的系统评价左乙拉西坦添加治疗难治性部分性发作癫癎的疗效和药物安全性。方法计算机检索1998年1月-2010年12月Cochrane图书馆、MEDLINE、EMbase、社会科学引文索引、维普中文科技期刊、中国知网中国期刊全文数据库和中国生物医学文献数据库,并手工检索相关杂志,由两名研究者独立进行质量评价及数据分析,RevMan 5.0统计软件进行Meta分析。结果根据Cochrane5.0.2版随机对照临床试验质量评价标准,纳入11项随机对照临床试验共1981例受试者(左乙拉西坦组1192例、安慰剂对照组789例)。Meta分析结果显示,左乙拉西坦组每周部分性癫癎发作频率减少≥50%的病例数高于对照组(1000 mg/d:OR=2.990,P=0.000;2000 mg/d:OR=3.870,P=0.000;3000 mg/d:OR=3.440,P=0.000);每周发作频率减少≥75%的病例明显高于对照组(1000 mg/d:OR=3.130,P=0.000;2000 mg/d:OR=5.060,P=0.000;3000 mg/d:OR=4.730,P=0.000);完全不发作病例明显高于对照组(1000 mg/d:OR=5.080,P=0.001;2000 mg/d:OR=4.420,P=0.050;3000 mg/d:OR=4.150,P=0.000)。左乙拉西坦组失访率与安慰剂对照组之间差异无统计学意义(P>0.05)。治疗期间常见药物不良反应包括嗜睡、头晕、乏力、鼻咽炎、精神行为异常等,两组精神行为不良反应方面存在异质性(P=0.360,I^2=8.000%)。结论现有证据显示,左乙拉西坦添加治疗难治性部分性发作癫癎的疗效与安慰剂组相比效果显著,保留率高;药物安全性应注意其所引起的精神行为异常。Objective To evaluate the effects and tolerability of adjunctive levetiracetam （LEV） in refractory partial seizures. Methods Relevant research articles about randomized controlled trials of adjunctive LEV in refractory partial seizures from January 1998 to December 2010 were retrieved from Cochrane Library, MEDLINE, EMbase, Social Sciences Citation Index （SSCI）, VIP, Chinese National Knowledge Infrastructure （CNKI） database, China Biology Medicine （CBM）. Two reviewers independently evaluated the quality of the included articles and abstracted the data. A Meta-analysis was conducted by using RevMan 5.0 software. Results According to the enrollment criteria, eleven prospective, randomized controlled clinical trials with a total of 1192 in LEV group and 789 in placebo group were finally selected. The reduction in three endpoints （a 50% or greater reduction of partial seizure frequency per week, a ？5% or greater reduction of partial seizure frequency per week and seizure free） was significant in LEV group than placebo group. There was no significance between LEV group and placebo group in the withdrawl rate （1000 mg/d： OR = 1.180, 95%CI： 0.690-2.010, P= 0.540; 2000 mg/d： OR = 1.530, 95%Ch 0.770-3.030, P= 0.230; 3000 mg/d： OR -- 1.000, 95% CI： 0.620-1.600, P = 1.000）. The following adverse events were associated with LEV： somnolence （OR---1.720, 95%CI： 1.280-2.310, P = 0.000）, dizziness （OR = 1.490, 95% CI： 1.000-2.220, P = 0.050）, asthenia （OR = 1.670, 95%CI： 1.140-2.240, P = 0.008）, nasopharyngitis （OR = 1.120, 95%CI： 0.710-1.760, P = 0.630）, psychiatric and behavioral abnormalities （OR = 2.120, 95%CI： 1.370-3.280, P--0.000）. Conclusion LEV is effective and well tolerated when added to existing therapy in patients with refractory partial seizures compared with control drugs. Further studies are needed to identify the effects of monotherapv of LEV in partial seizures.

关 键 词：抗惊厥药 癫痫 复杂部分性 META分析 随机对照试验 

分 类 号：R742.1[医药卫生—神经病学与精神病学]