摘要
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 effectiveness of levetiracetam( LEV) added on to usual care,in treating children refractory partial seizure epilepsy. Methods We searched the Cochrane library,EMBASE and PubMed between January 1998-January 2017,We systematically searched CNKI database and Wanfang data,Chinese biology medline and the manual retrieval related magazines. RevMan 5. 3 statistical software for Meta analysis. Results According to the enrollment criteria,fourtrials were included involving 498 participants according to the intent-to-treat,268 for LEV,and 230 for placebo groups. We assessed the following outcomes: 50% or greater seizure reduction,seizure freedom,adverse effects,proportion of dropouts and quality of life. There was no evidence of statistical heterogeneity between trials. We assessed outcomes by using a meta-analysis to calculate odds ratio( OR) with 95% confidence intervals( 95% CI).For the 50% or greater reduction in focal seizure frequency outcome,the OR was significantly in favour of LEV [OR = 2. 94,95% CI( 1. 99,4. 34) ]. Participants were significantly more likely in LEV groups than placebo groups to get seizure free[OR = 5. 31,95% CI( 2. 49,11. 32) ]. There was no significance between LEV groups and placebo groupsin the rate of Treatment withdrawal[OR = 0. 76,95% CI( 1. 32,1. 82) ].Somnolence[OR = 2. 57,95% CI( 1. 36,4. 86) ]and changes in behaviour [OR = 2. 54,95% CI( 1. 56,4. 14) ] were significantly associated with LEV. Other adverse effects were not significantly associated with LEV in children. Conclusion The existing evidence suggests that LEV add in treatment of children refractory epilepsy have definite curative effect,LEV long-term treatment effect is stable,good security,retention rate is higher,can be used in clinical further promotion.
出处
《癫痫杂志》
2017年第2期99-106,共8页
Journal of Epilepsy
基金
国家自然科学基金(81273242)
江苏省自然科学基金(BK20161227)
