加巴喷丁添加治疗难治性癫痫的系统评价

A Systematic Review of Efficacy and Safety of Gabapentin as Add-on Therapy for Refractory Epilepsy

目的：系统评价加巴喷丁（gabapentin,GBP）添加治疗难治性癫痫的有效性及安全性。方法：使用计算机检索Pub Med、EMbase、MEDLINE（Ovid）、Cochrane图书馆、中国期刊全文数据库（CNKI）、维普数据库、万方数据库等,查找GBP添加治疗难治性癫痫的随机对照试验（RCT）,检索时间均从建库至2013年6月。对符合纳入标准的RCT,由2位评价员按Cochrane系统评价的方法,独立进行资料提取、质量评价并交叉核对后,采用Rev Man 5.2软件进行文献荟萃分析（Meta分析）。结果：共纳入9个研究,合计1 498例患者。Meta分析结果显示,与安慰剂相比,GBP添加治疗可以提高难治性癫痫治疗的有效率（RR=1.90,95%CI=1.45-2.48,P〈0.000 01）;2组因不良反应而退出研究的患者所占比例比较,差异无统计学意义（RR=1.03,95%CI=0.72-1.47,P=0.88）;嗜睡、头晕、疲劳、共济失调等不良反应发生率方面,GBP添加治疗组高于安慰剂组,差异有统计学意义（P〈0.05）;头痛、恶心、呕吐、复视、体质量增加、鼻炎、抽搐、震颤等不良反应发生率方面,2组相近,差异无统计学意义（P〉0.05）。在阳性对照研究中,GBP添加治疗难治性癫痫的有效性和安全性与氨己烯酸、拉莫三嗪相近。结论：目前的研究结果表明,GBP添加治疗难治性癫痫,明显有效,且安全性较好。

OBJECTIVE： To assess the effectiveness and safety of Gabapentin（ GBP） as add-on therapy for refractory epilepsy. METHODS： Randomized controlled trials（ RCTs） on GBP treating refractory epilepsy were searched from the following data-bases as Pub Med,EMbase,MEDLINE（ Ovid）,the Cochrane Library,CNKI,VIP and WANFANG from the date of their establishment to June 2013. The data of RCTs meeting the inclusive criteria were extracted according to Cochrane methods by two reviewers independently,and after the quality was evaluated and crosschecked,meta-analyses were conducted using Rev Man 5. 2 sotware. RESULTS： A total of nine studies involving 1 498 patients were included. The results of Meta-analyses showed that： compared with placebo,GBP was more effective（ RR = 1. 90,95% CI = 1. 45-2. 48,P〈0. 000 01）; The withdrawal proportion because of adverse drug reaction（ ADR）,both groups were no statistically significant difference（ RR = 1. 03,95% CI = 0. 72-1. 47,P = 0. 88）; The incidences of ADR such as somnolence,Dizziness,fatigue,ataxia etc,were higher in the GBP group than the placebo group; the incidences of nausea,diplopia,weight increase,rhinitis,convulsions and tremor were alike between the two groups. In the positive control studies,the efficacy and safety of GBP were similar to Vigabatrin,lamotrigine.CONCLUSIONS： The present study shows that GBP is effective and safe as add-on therapy for refractory epilepsy.