舒眠胶囊联合化学药治疗失眠症的系统评价

目的 系统评价舒眠胶囊联合化学药治疗失眠症的临床疗效与安全性。方法 计算机检索PubMed、中国生物医学文献数据库（CBM）、中国知网（CNKI）、维普数据库（VIP）和万方数据库，收集舒眠胶囊联合化学药（试验组）对比单用化学药（对照组）治疗失眠症的随机对照试验（RCT），并追溯纳入研究的参考文献。检索时限为2000年1月-2017年7月。严格按照纳入与排除标准筛选文献、提取有效数据并对纳入文献进行方法学质量评价，采用RevMan 5.0软件对各效应指标进行Meta-分析。结果 共纳入10个RCT，共计1 051例失眠症患者。Meta-分析结果显示：试验组临床总有效率高于对照组OR=2.23，95% CI（2.18，4.77），P<0.001]，两组比较差异有统计学意义；试验组治疗周期末匹兹堡睡眠质量指数量表（PSQI）评分低于对照组MD=-1.88，95% CI（-2.58，-1.17），P<0.001]，差异有统计学意义；试验组与对照组不良反应发生率相当OR=0.68，95% CI（0.33，1.40），P=0.29]，差异无统计学意义。结论 舒眠胶囊联合化学药治疗失眠症的临床疗效优于单用化学药治疗。由于本系统评价纳入的文献质量较低、且样本量小，尚需更多高质量RCT予以进一步的证实。

Systematic review of Shumian Capsule combined with chemical drugs in treatment of insomnia

Objective To evaluate the efficacy and safety of Shumian Capsule combine with chemical drugs (experimental group) compared with chemical drugs (control group) in treatment of insomnia. Methods The randomized controlled trials (RCT) of Shumian Capsule combined with western medicine in treatment of insomnia were searched from the database including Pubmed, CBM, CNKI, VIP database, and Wanfang by computer from January 2000 to July 2017. References of included studies were also retrieved. Screened studies according to inclusion and exclusion criteria, extracted valid data, and assessed the methodological quality of including literatures. Meta-analysis was performed using RevMan 5.0 software. Results A total of ten RCTs were included, including 1051 patients with insomnia. Meta-analysis results showed that, compared with control group, experimental group improved total effective rateOR=2.23, 95% CI(2.18, 4.77), P<0.001], and reduced the PSQI scoreMD=-1.88, 95% CI(-2.58, -1.17), P<0.001], the difference was statistically; There was no signficant difference between the two group in the incidences of adverse effectOR=0.68, 95% CI(0.33, 1.40), P=0.29]. Conclusion Shumian Capsule combined with chemical drugs showed better efficacy for the insomnia compared with chemical drugs alone. However, due to the low quality and small sample size, the RCTs with high quality were still needed to be further validated.