交通心肾法治疗心肾不交型失眠的有效性和安全性评价

An evaluation on the efficacy and safety of the Jiaotong Xinshen method in the treatment of cardio-renal dissonant insomnia

目的:系统评价交通心肾法治疗心肾不交型失眠的有效性和安全性。方法:计算机检索中国知网、维普、万方数据、中国生物医学文献数据库、PubMed、Cochrane图书馆等数据库,收集中药组方和西药治疗对心肾不交型失眠的疗效和安全性的随机对照试验。由2名研究人员独立筛选文献,获得符合纳入标准的文献。使用Cochrane风险偏倚评估工具评估纳入文献的质量,采用RevMan 5.4软件进行Meta分析。结果:共检索1053篇文献,纳入19项随机对照试验,涉及1440例患者,治疗组725例(采用中药组方治疗),对照组715例(采用镇静催眠类药物治疗)。Meta分析结果显示,两组患者的临床总有效率、治愈率、匹兹堡睡眠质量指数(Pittsburgh Sleep Quality Index,PSQI)评分的差异均有统计学意义(均P<0.001)。结论:中药组方治疗心肾不交型失眠的总有效率、治愈率和对PSQI评分的改善作用优于西药,且安全性良好。

Objective:To systematically evaluate the efficacy and safety of the Jiaotong Xinshen method(交通心肾法)in the treatment of cardio-renal dissonant insomnia.Methods:In CNKI,VIP,Wanfang Data,CBM,PubMed,Cochrane Library and other databases,the randomized controlled trials on the efficacy and safety of TCM prescriptions and Western medicines in the treatment of cardio-renal dissonant insomnia were searched by computer to collect.The literature met the inclusion criteria was screened and selected by two researchers independently.Cochrane Risk Bias Assessment Tool was used to assess the quality of the included literature,and a Meta-analysis was performed by RevMan 5.4 software.Results:A total of 1053 studies were retrieved and 19 randomized controlled trials were included,involving 1440 cases,with 725 cases in the test group(treated with TCM medicine)and 715 cases in the control group(treated with sedative hypnotic medicines).The result of the Meta-analysis showed that there were statistically signifcant differences between the two groups in the total clinical efficiency,cure rate and PSQI score(all P=0.001).Conclusion:TCM prescription on cardio-renal dissonant insomnia is better than Western medicine in the total efficiency,cure rate,and the amelioration of PSQI score,and the safety is good.