酸枣仁汤治疗失眠的有效性与安全性的系统评价和Meta分析  

Systematic Reviews and Meta-analysis on the Effectiveness and Safety of Suanzaoren Decoction in the Treatment of Insomnia

作　　者：张玲[1] 游秋云[2] 方侃[1] 周圆[1] Zhang Ling;You Qiuyun;Fang Kan;Zhou Yuan(TaiHe Hospital Affiliated to Hubei University ofMedicine,Shiyan 442000,China;Hubei University of Chinese Medicine,Wuhan 430065,China)

机构地区：[1]湖北医药学院附属太和医院,十堰442000 [2]湖北中医药大学,武汉430065

出　　处：《中国药事》2021年第11期1291-1301,共11页Chinese Pharmaceutical Affairs

摘　　要：目的:系统评价酸枣仁汤辅助治疗失眠的有效性与安全性,以期为其临床治疗提供循证医学参考。方法:计算机检索中国知网(CNKI)、维普(VIP)、万方(Wanfang)、中国生物医学文献数据库(CBM)、PubMed、EMbase和Cochrane Library等数据库,收集酸枣仁汤联合西药常规治疗(试验组)对比单用西药常规治疗(对照组)对失眠的疗效和安全性的随机对照试验(Randomized Controlled Trial,RCT)。由2位研究者对符合纳入标准的临床研究进行资料提取后,使用Cochrane风险偏倚评估工具对纳入研究质量进行评价,采用RevMan 5.4软件进行Meta分析。结果:共纳入35项研究,涉及3200例患者,其中试验组1604例,对照组1596例。总体上,所纳研究质量偏低。Meta分析结果显示,与西药常规治疗相比,酸枣仁汤辅助治疗失眠可以提高总有效率(RR=1.26,95%CI[1.21,1.30],P<0.00001),改善匹兹堡睡眠质量指数(PSQI)评分(MD=-3.99,95%CI[-4.59,-3.39],P<0.00001)和睡眠状况自评量表(SRSS)评分(MD=-5.17,95%CI[-5.55,-4.79],P<0.00001),以及降低不良反应的发生率(RR=0.35,95%CI[0.25, 0.48],P<0.00001)。结论:酸枣仁汤辅助治疗失眠具有较好的疗效,且安全性良好。但该研究存在一定局限性,纳入研究总体质量较低,影响结果的可靠性,需更多高质量研究予以验证。Objective: To systematically evaluate the effectiveness and safety of Suanzaoren decoction in the treatment of insomnia in order to provide evidence-based references for its clinical treatment. Methods:Databases, such as CNKI, VIP, Wanfang, CBM, PubMed, EMbase, Cochrane Library, etc., were searched to collect the randomized controlled trials(RCT) on the Suanzaoren decoction by comparing integrated Western medicines(the treatment group) with the conventional Western medicine alone(the control group) in the treatment of insomnia. After the data of clinical studies that met the inclusion criteria were extracted by two researchers,the Cochrane risk-of-bias tool was used to evaluate the methodology quality, and RevMan 5.4 was used for Metaanalysis. Results: A total of 35 studies were included, involving 3200 participants with 1604 in the treatment group and 1596 in the control group. The overall quality of the RCTs was relatively low. Meta-analysis showed that Suanzaoren decoction for insomnia, compared with conventional Western medicines could improve the total efficacy rate(RR= 1.26, 95%CI[1.21, 1.30], P<0.00001), PSQI(MD=-3.99, 95%CI[-4.59,-3.39], P<0.00001)and SRSS(MD=-5.17,95%CI[-5.55,-4.79], P<0.00001), as well as reduce the incidence of adverse reactions(RR= 0.35, 95%CI[0.25, 0.48], P<0.00001). Conclusion: Suanzaoren decoction has demonstrated promising therapeutic efficiency and safety in treatment of insomnia. However, this study has certain limitations since the overall quality of included RCTs is relatively low, affecting the reliability of the results, and further high-quality studies are required for verification.

关 键 词：酸枣仁汤 失眠 随机对照试验 系统评价 META分析 

分 类 号：R285.6[医药卫生—中药学]