加巴喷丁治疗不宁腿综合征的系统评价

目的系统评价加巴喷丁治疗不宁腿综合征的临床疗效和安全性。方法计算机检索PubMed、EBMbase、CENTRAL及CBM等数据库,全面收集加巴喷丁治疗不宁腿综合征的随机对照试验(RCT)。按Cochrane系统评价方法对纳入研究进行资料提取和质量评价后,采用RevMan5.1软件进行Meta分析。结果共纳入7个RCT,1 163例患者,包括4个安慰剂平行对照试验和3个安慰剂交叉试验。Meta分析结果显示:①不宁腿综合征改变量(IRLSSG评分),加巴喷丁组明显优于安慰剂组[MD=–3.24,95%CI(–4.40,–2.09),P<0.000 01];②反应率(用研究者评价的CGI-I评分),加巴喷丁组(77%)较安慰剂组(50%)有更高的反应率[RR=1.81,95%CI(1.54,2.11),P<0.000 01];③睡眠质量:加巴喷丁组较安慰剂组能更好地减少睡眠紊乱[MD=–11.31,95%CI(–14.46,–8.16)]、保证睡眠质量[MD=0.27,95%CI(0.10,0.44)]和减轻日间嗜睡[MD=–3.96,95%CI(–6.42,–1.50)];④不宁腿综合征疼痛评分,加巴喷丁组较安慰剂组更好地减轻疼痛[MD=–0.97,95%CI(–1.47,–0.47)]。不良反应主要有嗜睡(3.1%～26.5%)、头晕(2.1%～19.5%),且加巴喷丁组发生率更高(嗜睡:P<0.000 01;头晕:P<0.000 1)。结论加巴喷丁能有效改善不宁腿综合征患者的病情,提升睡眠质量,减轻疼痛,耐受性良好。

Gabapentin for Restless Legs Syndrome:A Systematic Review

Objective To assess the efficacy and safety of gabapentin for restless legs syndrome(RLS).Methods Such databases as PubMed,EMbase,CENTRAL and CBM were searched for collecting the randomized controlled trials(RCTs) on the efficacy and/or tolerability of gabapentin for restless legs syndrome.Methodological quality of the trials was evaluated using the Cochrane risk-of-bias criteria,and meta-analysis was carried out using RevMan 5.1.Results Seven RCTs involving 1 163 patients which met the criteria were included,of which 4 were placebo parallel controlled trials and 3 were placebo cross-over trials.The outcomes of meta-analysis suggested that a) As to the change of RLS severity based on IRLSSG score,gabapentin was superior to placebo in alleviating the severity of RLS(MD= –3.24,95%CI –4.40 to –2.09,P<0.000 01);b) As to the response rate based on investigator-rated CGI-I scale,it was higher in the gabapentin group(77%) compared with that in the placebo group(50%)(RR=1.81,95%CI 1.54 to 2.11,P<0.000 01);c) As to quality of sleep,gabapentin was superior to placebo in reducing sleep disturbance(MD= –11.31,95%CI –14.46 to –8.16),assuring quality of sleep(MD= 0.27,95%CI 0.10 to 0.44) and alleviating daytime somnolence(MD= –3.96,95%CI –6.42 to –1.50);and d) As to the RLS pain score,gabapentin was better in relieving pain compared with placebo(MD= –0.97,95%CI –1.47 to –0.47).In addition,main side effects were somnolence(3.1% to 26.5%) and dizziness(2.1% to 19.5%),and there was a significant difference between two groups.Conclusion Gabapentin can effectively alleviate RLS patients’ condition,improve quality of sleep,relieve pain and show good tolerability.