百乐眠胶囊治疗睡眠障碍疗效与安全性的系统评价

Efficacy and Safety of Bailemian Capsule in the Treatment of Sleep Disorder:A Systematic Review

目的:系统评价百乐眠胶囊治疗睡眠障碍的疗效与安全性,为临床提供循证参考。方法:计算机检索中国生物医学文献数据库、中国期刊全文数据库、万方数据库和中文科技期刊数据库,收集单独或联合使用百乐眠胶囊(试验组)对比其他药物(对照组)治疗睡眠障碍的随机对照试验(RCT),提取纳入研究的特征信息并按照Cochrane系统评价员手册5.1.0评价质量后,采用Rev Man 5.2统计软件进行Meta分析。结果:共纳入15项RCT,合计1 288例患者。Meta分析结果显示,试验组患者总有效率[OR=3.45,95%CI(2.52,4.71),P<0.001]显著高于对照组,匹兹堡睡眠质量指数(PSQI)评分[MD=-1.92,95%CI(-2.41,-1.44),P<0.001]和不良反应发生率[OR=0.16,95%CI(0.08,0.33),P<0.001]均显著低于对照组,差异均有统计学意义。结论:百乐眠胶囊治疗睡眠障碍疗效较好,可以显著降低患者PSQI评分,安全性亦较好。

OBJECTIVE： To systematically review the efficacy and safety of Bailemian capsule in the treatment of sleep disorder, and provide evidence-based reference for clinic. METHODS： Retrieved from CBM, CJFD, Wanfang Database and VIP Data- base, clinical trials about alone or combined with Bailemian capsule （test group） versus other medicines （control group） in the treatment of sleep disorder were collected. Meta-analysis was performed by using Rev Man 5.2 software after data extraction and quality evaluation using cochrane system evaluation manual 5.1.0 . RESULTS： Totally 15 RCTs were included, involving 1 288 patients. Results of Meta-analysis showed, the total effective rate [OR=3.45,95%CI（2.52,4.71）,P〈0.001] in test group was significantly higher than control group, pittsburgh sleep quality index （PSQI） score [MD=1.92,95%CI（-2.41,- 1.44）,P〈0.001] and the incidence of adverse reactions[OR=0.16,95%CI（0.08,0.33）,P〈0.001] were significantly lower than control group, with statistical significances. CONCLUSIONS： Bailemian capsule shows good efficacy in the treatment of sleep disorder, it can significantly improve PSQI score with good safety, and does not increase the incidence of adverse reactions.