舒肝解郁胶囊治疗轻、中度抑郁的疗效与安全性的系统评价

A Systematic Review of Therapeutic Efficacy and Safety of Shugan Jieyu Capsules in the Treatment of Mild to Moderate Depression

目的:系统评价舒肝解郁胶囊治疗轻、中度抑郁症的疗效及安全性。方法:计算机检索Cochrane图书馆、EMbase、PubMed、中国期刊全文数据库、中国生物医学文献数据库、维普数据库、万方数据库中关于舒肝解郁胶囊治疗轻、中度抑郁症的随机对照试验(RCT)。由两名数据员按纳入与排除标准独立筛选试验,并对纳入研究的方法学质量进行评价,提取资料;用RevMan5.14统计学软件对数据进行Meta分析。结果:共纳入15项RCT,包括1240例患者。Meta分析结果显示,舒肝解郁胶囊治疗轻、中度抑郁症的总有效率高于对照组,但两组比较差异无统计学意义[OR=1.35,95%C(I0.89,2.07),P=0.16];改善汉密尔顿抑郁量表(HAMD)评分值优于对照组[MD=-1.39,95%C(I-2.52,-0.26),P=0.02],不良反应发生率低于对照组[OR=0.44,95%C(I0.26,0.73),P<0.01],两组比较差异有统计学意义。结论:舒肝解郁胶囊治疗轻、中度抑郁症疗效和安全性均较好。由于纳入研究质量不统一,本结论尚需要更多大样本、高质量的RCT予以证实。

OBJECTIVE：To evaluate the effectiveness and safety of Shugan jieyu capsules in the treatment of mild to moderate depression.METHODS：Retrieved from Cochrane library,EMbase,PubMed,CNKI,CBM,VIP,Wanfang database,RCT about Shugan jieyu capsules in the treatment of mild to moderate depression were collected.2 reviewers independently retrieved the literatures according to the inclusion and exclusion criteria,evaluated the methodological quality of included trials,and extracted data.The data analysis was performed by Rev Man 5.14 software.RESULTS：A total of 15 RCT were included,involving 1 240 patients.Results of Meta-analysis showed that total effective rate of Shugan jieyu capsule group was higher than control group in the treatment of mild to moderate depression,there was no statistical significance between 2 groups [OR=1.35,95%CI（0.89,2.07）,P=0.16];HAMD score of Shugan jieyu capsule group was better than that of control group [MD=-1.39,95%CI（-2.52,-0.26）,P=0.02],and the incidence of ADR in Shugenjieyu capsule group was also better than in control group [OR=0.44,95%CI（0.26,0.73）,P0.01].There was statistical significance.CONCLUSIONS：Shugan jieyu capsule is effective and has good safety in the treatment of mild to moderate depression.However,due to the quality of included studies,more large-scale high-quality RCT are needed.