逍遥散加减治疗失眠临床疗效的Meta分析

A meta-analysis clinical efficacy of Xiaoyao powder on insomnia

目的:系统评价逍遥散加减治疗失眠的临床疗效。方法:利用计算机检索数据库有中国知网、中国生物医学文献数据库、万方数据库期刊论文资源、维普期刊全文数据库及PubMed发表的逍遥散及其加减方治疗失眠的中英文随机对照试验,检索日期为自建库以来至2020年4月30日。由两名研究者进行文献筛选、资料提取及质量评价,采用Cochrane协作网的偏倚风险评估工具对纳入研究进行方法学质量评价,采用RevMan 5.3.0软件、Stata 13.0软件进行统计和Meta分析。结果:共有18项研究纳入,共1 573例,纳入研究质量中等居多。Meta分析结果显示,逍遥散加减治疗失眠的总有效率[比值比(Odds Ratio,OR)=2.74,95%置信区间(Confidence Interval,CI)(2.05,3.65),Z=6.86,P=0.000]、痊愈率[OR=2.45,95%CI(1.95,3.06),Z=7.8,P=0.000]、匹兹堡睡眠质量指数(Pittsburgh Sleep Quality Index,PSQI)评分[均数差(Standard Mean Difference,SMD)=-2.250,95%CI(-3.380,-1.120),Z=3.9,P=0.000]。逍遥散加减联合常规治疗失眠的总有效率[OR=4.48,95%CI(1.51,13.33)Z=2.70,P=0.007]。结论:逍遥散加减治疗失眠疗效确切。但基于纳入研究数量较少、质量偏低。结论:临床仍需更多高质量的随机对照试验加以验证。

Objective:To systematically evaluate the clinical efficacy of Xiaoyao powder(逍遥散)on insomnia.Methods:Databases included CNKI,CBM,COJ,VIP and PubMed were searched to collect the chinese and english randomized controlled trials of Xiaoyao powder and its modified prescription in the treatment of insomnia published up to April 30,2020.Literature screening,data extraction and quality evaluation were carried out by two reviewers,and the methodological quality of the included study was evaluated by using the bias risk assessment tool of Cochrane collaboration network.RevMan 5.3.0 and Stata 13.0 software were used for statistics and meta-analysis.Results:A total of 18 studies were included,involving 1573 cases,most of which were of medium quality.The results of meta-analysis showed the total effective rate[OR=2.74,95%CI(2.05,3.65),Z=6.86,P=0.000],cure rate[OR=2.45,95%CI(1.95,3.06),Z=7.8,P=0.000],Pittsburgh sleep quality index score[SMD=-2.250,95%CI(-3.37,-1.12),Z=3.9,P=0.000]of Xiaoyao powder in the treatment of insomnia,and total effective rate of Xiaoyao powder combined with routine treatment of insomnia[OR=4.48,95%CI:1.51-13.33,Z=2.70,P=0.007].Conclusion:Xiaoyao powder is effective in the treatment of insomnia.Due to the small number and low quality of the included studies,more high-quality randomized controlled trials are needed to verify the conclusions.