普瑞巴林治疗广泛性焦虑障碍的疗效与安全性的系统评价

目的系统评价普瑞巴林治疗广泛性焦虑障碍(GAD)的临床疗效和安全性。方法电子检索CENTRAL、Pubmed、EMbase和中国生物文献数据库文献(CBM),全面收集普瑞巴林治疗GAD的随机对照试验(RCTs),采用Cochrane系统评价方法评价纳入RCTs的方法学质量后,采用RevMan 5.1.4软件对提取的数据进行分析。结果纳入7个RCTs,共2 410例患者。与安慰剂相比,普瑞巴林150 mg·d~(-1)治疗GAD有效率无统计学差异[RR=1.32,95%CI(0.98,1.79),P=0.07],普瑞巴林固定剂量200～450 mg·d~(-1)[RR=1.60,95%CI(1.34,1.93),P<0.01]、600 mg·d~(-1)[RR=1.42,95%CI(1.18,1.70),P=0.000 2]以及可变剂量组[RR=1.25,95%CI(1.06,1.49),P=0.01]有效率差异均有统计学意义。与安慰剂组相比,普瑞巴林固定剂量组150～450 mg·d~(-1)以及可变剂量组因不良反应退出试验人数差异无统计学意义(分别为P=0.26,P=0.12);而普瑞巴林600 mg·d~(-1)组因不良反应退出试验人数差异有统计学意义[RR=1.76,95%CI(1.16,2.68),P=0.008]。结论普瑞巴林200～450 mg·d~(-1)治疗GAD有效且安全性好。

Efficacy and safety of pregabalin in treatment of generalized anxiety disorder:a systematic review

AIM To evaluate the efficacy and safety of pregabalin monotherapy for treating generalized anxiety disorder(GAD).METHODS The randomized controlled trials(RCTs) of pregabalin monotherapy for treating GAD were searched in CENTRAL,Pubmed,EMbase and the Chinese Biomedical Literature Database (CBM).The quality of the included RCTs was evaluated by using methods recommended by the Cochrane Collaboration.Meta-analyses were performed with RevMan 5.1.4 software.RESULTS Seven RCTs with 2 410 participants were included.Compared with placebo,there were not significant differences in pregabalin 150 mg·d~(-1) in responder rate(RR = 1.32,95%CI(0.98,1.79),P = 0.07).But the results showed significant differences in pregabalin fixed-dose 200 - 450 mg·d~(-1)(RR = 1.60,95%CI(1.34,1.93),P<0.01),600 mg·d~(-1)(RR = 1.42,95%CI(1.18,1.70),P= 0.000 2) and flexible-does group(RR = 1.25,95%CI(1.06, 1.49),P - 0.01) in responder rate.Compared with the placebo group,there were not significant differences in the fixed-dose 150 - 450 mg·d~(-1) group(RR = 0.78,95%CI(0.51,1.20),P = 0.26) and the flexible - does group(RR = 1.56,95%CI(0.89,2.73),P=0.12) in withdrawals due to adverse events.But the results showed significant differences in pregabalin 600 mg ? d~(-1) in withdrawals due to adverse events compared with placebo(RR = 1.76,95%CI(1.16,2.68),P= 0.008).CONCLUSION Pregabalin 200 - 450 mg·d~(-1) is an efficacious and safety therapy for GAD.