中医药治疗围绝经期失眠症的系统评价

摘要

目的:系统评价中医药治疗围绝经期失眠症的临床疗效与安全性.方法:计算机检索维普数据库(VIP)、中国知识资源总库(CNKI)、万方数据库,纳入中医药治疗围绝经期失眠症的随机对照试验或半随机对照试验,检索时限均从建库至2015年6月,对纳入研究的方法学质量进行评价,用RevMan 5.3软件进行统计分析.结果:共纳入11篇文献,合计866例患者.Meta分析结果显示:与对照组相比,治疗组在总有效率[OR=0.37,95％CI(0.24,0.57)]、用药后匹兹堡睡眠质量指数(PSQI)评分改善[OR=-0.98,95％CI (-1.61,-0.35)]、不良反应[OR=0.08,95％CI (0.03,0.18)]、复发率[OR=0.17,95％CI(0.05,0.59)]方面具有一定的优势,其差异均有统计学意义.结论:现有研究文献表明中药组对围绝经期失眠的总有效率、匹兹堡睡眠质量指数评分改善优于西药组,同时在不良反应发生率、复发率方面中药组低于西药组.但鉴于纳入研究文献数量和质量有限,上述结论尚需开展大样本、高质量、多中心的研究进一步验证,为临床和科研工作者提供更加科学、准确的参考依据.%Objective:To evaluate systematically the clinical efficacy and safety of traditional Chinese medicine in the treatment ofperi menopausal insomnia.Methods:Date on were retrieved by computers from the VIP database (VIP),China knowledge resources database (CNKI),Wanfang database,the randomized controlled trials or semi randomized controlled trials of traditional Chinese medicine in the treatment ofperi menopausal insomnia.The retrieval time-limit was from the start of the establishment of the database to June 2015.Meanwhile,the method ological quality of the included studies was evaluated,and the statistical analysis was performed with RevMan 5.3 soft vare.Results:A total of 11 articles were included,with a total of 866 patients.Meta analysis results showed that compared with the control group,the treatment group showed the advantages in the total effective rate [OR=0.37,95％CI(0.24,0.57)],Pittsburgh sleep quality index (PSQI) score [OR=-0.98,95％CI(-1.61,-0.35)] after medicine improved.Adverse reactions [OR=0.08,95％CI (0.03,0.18)],recurrence rate [OR=0.17,95％CI),(0.05,0.59)],and the difference was statistically significant.Conclusion:The existing research literatures show that the herb groups is su perior to western medicine group in total effective rate and PSQI score improvements,lower than western medicine group in the inicidence of adverse reaction and recurrence.But in view of the limited quantity and quality of the research literature,the conclusion still needs to be further validated by large sample,high quality and multi center studies to provide more scientific and accurate reference for clinical and scientific research workers.