度洛西汀治疗重性抑郁障碍有效性与安全性的Meta分析

Efficacy and Safety of Duloxetine in the Treatment of Major Depressive Disorder:a Meta-analysis

目的:系统评价度洛西汀治疗重性抑郁障碍(MDD)的疗效与安全性,为临床用药提供循证参考。方法:计算机检索Cochrane图书馆、PubMed、Embase、中国知网、中国生物医学文献数据库、维普数据库,收集度洛西汀(试验组)对比安慰剂(对照组)治疗MDD的随机对照试验(RCT)。筛选文献、提取资料后采用Cochrane系统评价员手册5.1.0偏倚风险工具对纳入研究进行质量评价,采用Rev Man 5.3软件进行Meta分析。结果:共纳入8项RCT,共计2772例。Meta分析结果显示,试验组患者Montgomery-Asberg抑郁评定量表总分减少值[MD=-3.99,95%CI(-4.75,-3.24),P<0.00001]、汉密尔顿焦虑量表总分减少值[MD=-2.12,95%CI(-3.66,-0.57),P=0.007]、临床全球印象-严重程度总分减少值[MD=-0.47,95%CI(-0.73,-0.21),P=0.0004]、临床总体印象改善量表总分减少值[MD=-0.58,95%CI(-0.92,-0.25),P=0.0006]、Sheehan残疾量表总分减少值[MD=-2.82,95%CI(-4.55,-1.09),P=0.001]均显著大于对照组;试验组患者恶心、口干、便秘、呕吐、头晕、嗜睡、失眠、多汗、食欲不振等发生率显著高于对照组(P<0.05),两组患者严重不良反应、腹泻、头痛、消化不良等发生率比较,差异均无统计学意义(P>0.05)。结论:度洛西汀治疗MDD的疗效显著,但会增加常见的轻微不良反应的发生。

OBJECTIVE:To systematically evaluate the efficacy and safety of duloxetine in the treatment of major depressive disorder(MDD),and to provide evidence-based reference for clinical drug use.METHODS:Retrieved from the Cochrane Library,PubMed,Embase,CNKI databases,CBM and VIP databases,randomized controlled trials(RCTs)about duloxetine(trial group)versus placebo(control group)in the treatment of MDD were collected.After literature screening and data extraction,the quality of included studies was evaluated by using Cochrane systematic evaluator manual 5.1.0.Rev Man 5.3 software was used for Meta-analysis.RESULTS:A total of 8 RCTs were included,involving a total of 2772 cases.Meta-analysis showed that the decrease of Montgomery-Asberg Depression Rating Scale[MD=-3.97,95%CI(-4.71,-3.24),P<0.00001],the decrease of Hamilton Anxiety Rating Scale[MD=-2.12,95%CI(-3.66,-0.57),P=0.007],the decrease of Clinical Global Impression-Severity[MD=-0.47,95%CI(-0.73,-0.21),P=0.0004],the decrease of Clinical Global Impression-Improvement Scale[MD=-0.58,95%CI(-0.92,-0.25),P=0.0006]and the decrease of Sheehan Disability Scale[MD=-2.82,95%CI(-4.55,-1.09),P=0.001]in trial group were significantly more than control group.The incidence of nausea,dry mouth,constipation,vomiting,dizziness,drowsiness,insomnia,hyperhidrosis and anorexia in the trial group was significantly higher than control group(P<0.05).There was no statistical significance in the incidence of serious ADR,diarrhea,headache and dyspepsia between 2 groups(P>0.05).CONCLUSIONS:Duloxetine shows significant therapeutic efficacy for the treatment of MDD,but it will increase the occurrence of common mild ADR.