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目的系统评价左乙拉西坦添加治疗儿童难治性部分性癫痫的疗效和耐受性。方法计算机检索1998年1月-2017年1月Cochrane图书馆、PubMed、EMbase、中国知网中国期刊全文数据库和万方及中国生物医学文献数据库,并手工检索相关杂志,RevMan 5.3统计软件进行Meta分析。结果根据Cochrane 5.0.2版随机对照临床试验质量评价标准,纳入4项随机对照临床试验共498例受试者(左乙拉西坦组268例、安慰剂对照组230例)。Meta分析结果显示,左乙拉西坦组部分性癫痫发作频率减少≥50%的病例数高于对照组[OR=2.940,95%CI(1.99,4.34),P<0.000 01];完全不发作病例明显高于对照组[OR=5.310,95%CI(2.49,11.32),P<0.000 01]。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[OR=0.760,95%CI(0.32,1.82),P=0.54]。药物不良反应中嗜睡[OR=2.57,95%CI(1.36,4.86)]及精神行为改变[OR=2.54,95%CI(1.56,4.14)]与左乙拉西坦组显著相关(P<0.05),其他不良反应与左乙拉西坦组无显著相关。结论现有Meta分析显示,左乙拉西坦添加治疗难治性部分性癫痫的疗效与安慰剂组相比效果显著。左乙拉西坦添加治疗儿童难治性癫痫部分性发作有确切的疗效,且长期治疗效果稳定,有良好的安全性,保留率较高,可在临床进一步推广使用。
Objective To evaluate the efficacy and tolerability of levetiracetam in the treatment of refractory partial epilepsy in children. Methods We searched the Cochrane Library, PubMed, EMbase, Chinese Journal Full-text Database and Wanfang and China Biomedical Literature Database from January 1998 to January 2017, and searched the related manuals by hand, RevMan 5.3 statistical software for meta-analysis . Results A total of 498 subjects (268 in the levetiracetam group and 230 in the placebo group) were included in four randomized controlled clinical trials, based on the Cochrane 5.0.2 randomized controlled clinical trial quality assessment criteria. Meta-analysis showed that the number of cases with partial seizure frequency reduction ≥50% in levetiracetam group was higher than that in control group [OR = 2.940, 95% CI (1.99, 4.34), P <0.000 01] Cases were significantly higher than the control group [OR = 5.310, 95% CI (2.49, 11.32), P <0.000 01]. There was no significant difference in the rate of lost between the levetiracetam group and the placebo group [OR = 0.760, 95% CI (0.32, 1.82), P = 0.54]. There were significant correlations between lethargy and adverse reactions (OR = 2.57, 95% CI 1.36, 4.86) and changes in mental behavior (OR 2.54, 95% CI 1.56, 4.14) ), Other adverse reactions and levetiracetam no significant correlation. Conclusions The current meta-analysis shows that the efficacy of levetiracetam in the treatment of refractory partial epilepsy is more effective than placebo. Levetiracetam added treatment of children with intractable epilepsy partial seizures have the exact effect, and long-term treatment of stable, good safety, high retention rate, can be further promoted in clinical use.