坤泰胶囊治疗女性更年期失眠伴焦虑抑郁的有效性和安全性的系统评价  

Efficacy and Safety of Kuntai Capsule in the Treatment of the Menopausal Women with Insomnia,Anxiety and Depression:a Systematic Review

作　　者：门晓亮[1] 李博[2,3] 金鸿雁[4] 赵丽萍[1] MEN Xiao-liang;LI Bo;JIN Hong-yan;ZHAO Li-ping(Beijing Daxing District Maternal and Children Health Care Hospital,Beijing 102600,China;Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University,Beijing 100010,China;Beijing Institute of Traditional Chinese Medicine,Beijing 100010,China;Peking University First Hospital,Beijing 100034,China)

机构地区：[1]北京市大兴区妇幼保健院,北京102600 [2]首都医科大学附属北京中医医院,北京100010 [3]北京市中医研究所,北京100010 [4]北京大学第一医院,北京100034

出　　处：《中国合理用药探索》2021年第6期15-21,共7页Chinese Journal of Rational Drug Use

基　　金：北京市大兴区妇幼保健院院级课题项目(2020001)。

摘　　要：目的:系统评价坤泰胶囊治疗女性更年期失眠伴焦虑抑郁的有效性和安全性。方法:检索the Cochrane Library、Pub Med、Embase、Web of Science、中国生物医学文献数据库(Sino Med)、中国知网(CNKI)、维普数据库和万方数据库自建库至2020年7月公开发表的坤泰胶囊治疗女性更年期失眠伴焦虑抑郁的相关随机对照试验,由2名调查人员独立筛选文献、提取资料和评价纳入研究的偏倚风险。应用Rev Man 5.4软件对纳入文献的研究数据和结果进行Meta分析。结果:共纳入4篇符合纳入标准的文献,Meta分析结果显示,干预组睡眠改善总有效率[RR=1.20,95%CI(1.11,1.30),P <0.0001]高于对照组,干预组治疗后焦虑自评量表评分[MD=-10.09,95%CI(-17.12,-3.07),P=0.005]和抑郁自评量表评分[MD=-9.25,95%CI(-16.04,-2.46),P=0.008]低于对照组,均有统计学差异;干预组不良反应[RR=0.50,95%CI(0.16,1.61),P=0.25]低于对照组,但无统计学差异。结论:坤泰胶囊治疗女性更年期失眠伴焦虑抑郁的疗效确切,尤其适用于有西药禁忌症的更年期患者,但因纳入文献的数量和质量有限,上述结论仍需大量高质量的临床试验加以验证。Objective: To systematically evaluate the efficacy and safety of Kuntai capsule in the treatment of the menopausal women with insomnia,anxiety and depression. Methods: Databases including the Cochrane Library,Pub Med,Embase,Web of Science,Sino Med,CNKI,VIP databases and Wanfang databases were searched from establishment to July 2020 to collect randomized controlled trials about Kuntai capsule for the menopausal women with insomnia,anxiety and depression. Two investigators independently screened the literature,extracted the data and evaluated the bias risk of the included studies. Rev Man 5. 4 software was used for Meta-analysis on the research data and results of the included literatures. Results: A total of 4 literatures that met the inclusion criteria were included. Meta-analysis results showed that the total effective rate of sleep improvement in the intervention group[RR = 1. 20,95% CI( 1. 11,1. 30),P < 0. 0001]was higher than that of the control group. After treatment,the scores of self-rating anxiety scale[MD =-10. 09,95% CI(-17. 12,-3. 07),P = 0. 005] and self-rating depression scale [MD =-9. 25,95% CI(-16. 04,-2. 46),P = 0. 008] were lower than those of the control group,and the differences were statistically significant. The adverse reactions in the intervention group [RR = 0. 50,95% CI( 0. 16,1. 61),P = 0. 25]were lower than those in the control group,but there were no statistical differences.Conclusion: Kuntai capsule is effective in the treatment of the menopausal women with insomnia,anxiety and depression,especially for menopausal patients with contraindications to western medicine. However,due to the limited number and quality of included literatures,the above conclusion still needs to be verified by a large number of high-quality clinical trials.

关 键 词：更年期 失眠 焦虑 抑郁 坤泰胶囊 系统评价 

分 类 号：R971[医药卫生—药品]