百乐眠治疗失眠的疗效和安全性的Meta分析

Meta analysis of efficacy and safety of Bailemian therapy for insomnia

目的评价百乐眠治疗失眠障碍的疗效、安全性及与疗程的关系。方法检索中国知网(CNKI)、万方数据库、中国优秀硕士/博士学位论文数据库、维普中文科技期刊数据库(VIP)、Cochrane图书馆、Pubmed、EMBASE、中国学术会议论文数据库中截至到2016年12月的百乐眠治疗失眠的文献,用Jadad量表评价文献质量,用Stata 14软件进行Meta分析。结果纳入文献20篇,共计2235例(观察组1284例,对照组951例)。百乐眠组治疗失眠的总有效率显著高于对照组(RR=1.20,95%CI:1.10~1.31),百乐眠治疗失眠的有效率显著高于西药亚组(RR=1.24,95%CI:1.07~1.44)及其他中药亚组(RR=1.13,95%CI:1.03~1.23)。百乐眠组治疗失眠降低匹兹堡睡眠质量指数(PSQI)评分优于对照组[标准化均数差(SMD)=-0.53,95%CI:-0.81^-0.26]。随着用药疗程的增加(第2、3、4周),百乐眠治疗失眠降低PSQI评分较西药亚组的优势逐渐显现(SMD2=-0.50,95%CI:0.83^-0.16;SMD3=-0.60,95%CI:-0.97^-0.24;SMD4=-1.67,95%CI:-0.63^-0.05)。百乐眠组治疗失眠的不良反应事件发生率显著低于对照组(RR=0.25,95%CI:0.16~0.38)。百乐眠组不良反应事件发生率显著低于西药亚组(RR=0.23,95%CI:0.15~0.36)。随着用药疗程的增加(第2、3、4、8周),百乐眠组不良反应事件发生率逐渐低于西药亚组(RR2=0.45,95%CI:0.22~0.92;RR3=0.23,95%CI:0.04~1.33;RR4=0.16,95%CI:0.08~0.33;RR8=0.19,95%CI:0.06~0.59)。结论百乐眠胶囊治疗失眠障碍的总体有效率、降低PSQI评分均优于西药和其他中药,具有较高的安全性,值得在临床上进一步推广使用。但是否随着用药疗程的增加总体有效率及降低PSQI评分优势越显著仍有待进一步研究验证。

Objective To evaluate the relationship among the efficacy,safety and the course of disease of Bailemian therapy for insomnia. Methods Literatures which before Dec,2016 on Bailemian therapy for insomnia were retrieved by China journal full-text database（ CNKI）,Wanfang database,Chinese outstanding master＇s/doctoral dissertation database,VIP science and technology periodical database,Cochrane library,Pubmed,EMBASE and Chinese academic conference papers,and then evaluated by Jadad scale,analyzed with Stata 14 software. Results Twenty articles including 2235 patients（ 1284 cases in Bailemian group,951 cases in control group） were included.Total effective rate of insomnia in Bailemian group was significantly increased than that in control group（ RR = 1. 20,95% CI： 1. 10-1. 31）. Total effective rate of insomnia in Bailemian group was significantly increased than that in western medicine subgroup（ RR = 1. 24,95% CI： 1. 07-1. 44） and Chinese medicine（ TCM） subgroup（ RR =1. 13,95% CI： 1. 03-1. 23）. Reducing Pittsburgh sleep quality index（ PSQI） score in Bailemian group was better than that in control group [standardized mean difference（ SMD） =-0. 53,95% CI：-0. 81--0. 26]. With the prolonged theraputic period（ 2nd,3th and 4th weeks）,the advantage of reducing PSQI score in Bailemian group was highlight gradually than western medicine subgroup（ SMD2 =-0. 50,95% CI： 0. 83--0. 16; SMD3 =-0. 60,95% CI：-0. 97--0. 24; SMD4 =-1. 67,95% CI：-0. 63--0. 05）. The incidence of adverse reaction in Bailemian group was significantly increased than that in control group（ RR = 0. 25,95% CI： 0. 16-0. 38）. The incidence of adverse reaction in Bailemian group was significantly increased than that in western medicine subgroup（ RR = 0. 23,95% CI： 0. 15-0. 36）. With the prolonged theraputic period（ 2nd,3th 4th and 8th weeks）,the incidence of adverse reaction in Bailemian group was highlight gradually than western medicine subgroup（ RR2 =0. 45,95% CI： 0. 22-0. 92; RR3 = 0. 23,95% CI： 0. 04-1. 33; RR4 = 0. 16,95% CI： 0. 08-0. 33; RR8 = 0. 19,95% CI： 0. 06-0. 59）. Conclusions Total effective rate and reducing PSQI score of Bailemian therapy forinsomnia are superior to other TCM and western medicine,and it is safety. It might be worth further popularizing in clinical use. Further studies are still needed to vertify whether the longer the courses are,the more significant of the efficacy on Bailemian therapy for insomnia than other drugs.