普瑞巴林治疗不宁腿综合征的Meta分析

Meta-analysis of Pregabalin in the Treatment of Restless Legs Syndrome

目的:系统评价普瑞巴林治疗不宁腿综合征(Restless leg syndrome,RLS)的疗效与安全性。方法:在Pubmed,EMBASE,OVID和中国期刊全文数据库(CNKI)中检索关于普瑞巴林治疗RLS的随机对照研究。分别对普瑞巴林和安慰剂组以国际RLS研究组评分量表(International RLS Study Group Rating Scale,IRLS)、总睡眠时间(Total Sleep Time,TST)、改变的加权均差(Weighted Mean Difference,WMD)和临床总体印象量表-总结改善(Clinical Global Impression-Improvement,CGI-I)显著率的相对危险度(Relative Risk,RR)为疗效评估指标,同时以不良事件的相对危险度为安全性评估指标。结果:最终纳入3项研究,共556位参与者,其中普瑞巴林组326例,安慰剂组220例。Meta分析显示普瑞巴林组相对于对照组的IRLS评分和TST的WMD分别为3.85(Z=5.47,P<0.00001)、44.57(Z=6.07,P<0.00001),CGI-I显著率RR=1.35(Z=4.76,P<0.00001);两组在不良事件RR=1.25(Z=0.93,P=0.35)。结论:普瑞巴林是治疗RLS的有效且安全的药物。

Objective:To systematically evaluate the efficacy and safety of pregabalin in treating restless legs syndrome(RLS).Methods:A search for randomized,placebo-controlled clinical trials of pregabalin in treating RLS in Pubmed,Medline(1966-),EMBASE(1980-,OVID,CNKI and Cochrane library database had been carried out.A meta-analysis of included clinical trials had been performed with RevMan 5.0software.The International RLS Study Group rating scale(IRLS)scores,the weighted mean difference(WMD)of changes in total sleep time(TST)and the relative risk(RR)of response based on the Clinical Global Impression-Improvement(CGI-I)scale scores had been calculated for efficacy evaluation.Safety had been assessed with RR of the adverse events(AE).Results:A total of 3clinical trials were included in this meta-analysis,in which 556patients were randomly assigned(326on pregabalin,220on placebo).Overall WMD for the changes in IRLS scores and TST were 3.85(Z=5.47,P<0.00001)and 44.57(Z=6.07,P<0.00001)respectively,and RR of response based on CGI-I were 1.35(Z=4.76,P<0.00001).The overall RR of pregabalin versus placebo were 1.25(Z=0.93,P=0.35)for AE.Conclusion:Pregabalin is an effective and safety drug for the treatment of RLS.