拉莫三嗪添加治疗癫痫有效性的系统评价

Systematic Review of the Effectiveness of Lamotrigine as Adjunctive Therapy for Epilepsy

目的:系统评价拉莫三嗪添加治疗癫痫的有效性。方法:以癫痫完全缓解比例、癫痫发作减少50%的比例、第一次发作时间、退出治疗时间、生命质量和认知功能情况等为指标,用系统评价方法评价有关拉莫三嗪添加治疗癫痫的随机对照试验。结果:共检索到20篇符合纳入标准的文献,分别有4项和3项试验比较了拉莫三嗪与安慰剂对照,及拉莫三嗪与其他新型抗癫痫药对照添加治疗难治性癫痫发作完全缓解的有效性。14项试验比较了拉莫三嗪与安慰剂添加治疗难治性癫痫其发作至少减少50%的有效性,对其中6项交叉试验第一阶段的数据进行合并,显示拉莫三嗪与安慰剂有效性的差异有统计学意义,RR=2.251,95% CI:1.146～4.424。3项试验比较了拉莫三嗪与其他新型抗癫痫药对照添加治疗癫痫的有效性,差异无统计学意义。结论:拉莫三嗪添加治疗癫痫发作完全缓解和减少发作50%有优于安慰剂组的趋势。拉莫三嗪添加治疗癫痫的生命质量优于安慰剂组。

Objective： To examine the effectiveness of lamotrigine （LTG） as adjunction therapy for epilepsy. Method： A systematic review was conducted on RCTs to examine the effectiveness of lamotrigine （LTG） as adjunction therapy for epilepsy. The outcome measures were seizure free during the study period, 50% reduction in seizure frequency, time of the first seizure and time of withdrawal during the study period, health-related quality of life and cognitive function. Result： A total of 20 studies were included in the review. Four trials and three trials compared the proportion of seizure free for adjunctive LTG versus placebo and LTG versus other newer AEDs in patients with refractory epilepsy. 14 trials compared the propor- tion of 50% responders for adjunctive trials of LTG versus placebo, the first phase data from six of the crossover studies were pooled, and the pooled RR showed a statistically significant difference, RR=2.251,95% CI： 1.146 -4. 424. Three trials compared the proportion of 50% responders for adjunctive trials of LTG versus other newer AEDs. Condusion： This review indicates that the proportion of seizure free and 50% responders in the lamotrigine group was significantly higher than that of placebo. Lamotrigine has a potential positive influence to the life quality of patients with epilepsy.