归脾汤治疗抑郁症疗效与安全性的系统评价

Systematic Review of Efficacy and Safety of the Treatment of Guipi Decoction for Depression

目的系统评价归脾汤与抗抑郁药比较的治疗抑郁症临床疗效和安全性。方法计算机检索中国知识资源总库(CNKI)、中文科技期刊数据库(VIP)、中国学术期刊数据库(万方数据)、中国生物医学文献数据库(CBM)、Embase、Pub Med、Cochrane Library中归脾汤治疗抑郁症临床随机对照试验相关文献。2名研究者独立筛选文献、提取资料及质量评价后,采用Rev Man 5.2软件进行Meta分析。结果共纳入9篇文献,共计受试者893例。Meta分析结果显示:归脾汤联合抗抑郁药物较单独使用抗抑郁药能显著降低HAMD评分(MD=-4.63,95%CI[-5.95,-3.32];P<0.001),归脾汤降低HAMD评分与抗抑郁药相当(MD=-0.30,95%CI[-4.22,3.62];P=0.88);归脾汤总有效率与抗抑郁药相当(RR=1.09,95%CI[0.82,1.44];P=0.54),归脾汤联合抗抑郁药物较单独使用抗抑郁药物总有效率明显升高(RR=1.26,95%CI[1.14,1.38];P<0.001)。纳入研究中未见严重不良反应报告。Meta分析显示归脾汤(RR=0.48,95%CI[0.40,0.58];P<0.001)及归脾汤联合抗抑郁药(RR=0.51,95%CI[0.30,0.85];P=0.010)不良反应发生率低于单独使用抗抑郁药。结论归脾汤治疗抑郁症有一定的疗效,且相对安全。但纳入研究质量普遍较低,尚需更多大样本、多中心、高质量的临床随机对照试验进一步验证。

Objective To evaluate the efficacy and safety ofGuipi Decoction vs. antidepressants for depression. Methods Articles about the randomized controlled trials (RCTs) ofGuipi Decoction for depression were searched in the databases of CNKI, VIP, Wanfang Data, CMB, Embase, PubMed, and Cochrane Library. Two researchers independently screened the articles, extracted the data, and evaluated the methodological quality. Meta-analyses were performed by using RevMan 5.2 software.Results A total of 9 RCTs articles involving 893 cases were included. Meta-analysis results suggested that as compared with antidepressants only,Guipi Decoction together with antidepressants was associated with a significantly greater reduction in HAMD scores (MD=-4.63, 95%CI [-5.95, -3.32];P<0.001). There was no significant difference in HAMD scores betweenGuipi Decoction used alone and antidepressants (MD=-0.30, 95%CI [-4.22, 3.62];P=0.88). As compared with antidepressants,Guipi Decoction together with antidepressants increased in the rates of total effective events (RR=1.26, 95%CI [1.14, 1.38];P<0.001). No serious adverse reactions were reported. Meta-analysis results suggested that the incidence of adverse reactions of Guipi Decoction(RR=0.48, 95%CI [0.40, 0.58];P<0.001) andGuipi Decoction together with antidepressants (RR=0.51, 95%CI [0.30, 0.85];P=0.010) were lower than that of antidepressants alone.Conclusion The present evidence suggests thatGuipi Decoction is effective and relatively safe for patients with depression. However, because the quality of included research was low, more large-scale RCTs with multicenter and high quality are needed for further verification.