舒肝解郁胶囊治疗轻中度抑郁发作的疗效和安全性的荟萃分析

Effi cacy and safety of Shugan Jieyu capsule for the treatment of mild or moderate depression

目的系统评价舒肝解郁胶囊治疗轻中度抑郁发作的临床疗效和安全性。方法检索Pubmed、Embase、Cochrane Database及中国生物医学文献数据库、CNKI数字图书馆、万方数据库、维普数据库收集从建库至2012年3月符合条件的文献资料,并手工检索《临床精神医学杂志》《中华神经精神杂志》等相关杂志,检索截止时间为2012年3月,纳入随机对照试验(RCT),由两位研究者独立进行文献筛选、资料提取和方法学质量评价后,采用Rev Man5.1.0软件进行荟萃分析。结果共纳入13项RCT共计990例患者,其中舒肝解郁胶囊组497例,其他药物治疗组493例。分析结果显示:应用汉密尔顿抑郁量表(HAMD-17或HAMD-24)减分率进行评定,舒肝解郁胶囊在治疗轻中度抑郁发作方面疗效与米氮平、文拉法辛、氟哌噻吨美利曲辛、舍曲林、帕罗西汀、氟西汀和西酞普兰等相当,差异无统计学意义[M-D=0.38,95%CI(-0.22,0.97),P=0.63]。在药物不良反应方面,舒肝解郁胶囊组明显低于其他各组[OR=0.25,95%CI(0.17,0.37),P<0.01]。结论舒肝解郁胶囊治疗轻中度抑郁发作疗效与米氮平、文拉法辛、氟哌噻吨美利曲辛、舍曲林、帕罗西汀、氟西汀和西酞普兰等相当,药物不良反应明显低于后者,是一种较为安全有效的药物。

Objective To evaluate the effi cacy and safety of Shugan Jieyu capsule in the treatment of mild or moderate depression. Methods The randomized controlled trials（RCTs） of Shugan Jieyu capsule in the treatment of mild or moderat depression were collected through following databases： the Cochrane Library, Pubmed, Wan Fang Data, Embase, CBM, CNKI and VIP. The trials selection based on inclusion, exclusion criteria, data extraction and quality assessment were conducted by two reviewers independently. The Meta-analyses was performed with Rev Man5.1.0 software. Results A total of 13 studies involving 990 participants were included. The results of Meta-analyses showed that the effect of the Shugan Jieyu capsule was similar to other antidepressant drugs（mirtazapine, venlafaxinel, fl upentixol and melitracen, sertraline, paroxetine, fluoxetine, and citalopram）in HAMD[M-D=0.38, 95%CI（-0.22,0.97）, P =0.63]. There was significant difference between two groups in side effects incidence [OR=0.25, 95%CI（0.17-0.37）, P〈0.01]. Conclusion The effi cacy of Shugan Jieyu capsule is similar to mirtazapine, venlafaxinel, fl upentixol and melitracen, sertraline, paroxetine, fl uoxetine, and citalopram. But its side effect is less, which is considered to be safe and effective.