交泰丸治疗失眠网络Meta分析  

Optimization Ratio between Coptis chinensis and Cinnamo in Jiaotai Pill plus Benzodiazepines for Insomnia in China∶a Network Meta-analysis

作　　者：王群[1,2,3] 孙世光 WANG Qun;SUN Shi-guang(Department of Pharmacy,Second Af-filiated Hospital of Shandong University of Traditional Chinese Medicine,Jinan,250001;Department of Pharmacy,Shan-dong Provincial Hospital of Integrated Medicine,Jinan,250001;Department of Vertigo,Jinan City Central People's Hos-pital,Jinan,250002)

机构地区：[1]山东中医药大学第二附属医院药学部,济南250001 [2]山东省中西医结合医院药学部,济南250001 [3]济南市市中区人民医院眩晕科,济南250002

出　　处：《中国中西医结合杂志》2020年第5期560-566,共7页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：国家自然科学基金项目(No.81302887);山东省科技发展计划项目(No.2014GSF119034);山东省中医药科技发展计划项目(No.2017-115,2019-0222)。

摘　　要：目的系统评价交泰丸(JTW)及其加减方(JTW+)联合苯二氮卓类药物(BDZ)治疗失眠临床疗效,并探讨JTW m∶n(m∶n代表黄连与肉桂配伍比例)治疗失眠的药味配伍比例。方法检索(从建库至2017年12月31日)中国知网数据库(CNKI)、维普数据库(VIP)、万方数据库(Wanfang)以及Medline、Em-base、Cochrane Library数据库有关JTW及JTW+治疗临床失眠随机对照试验文献;采用Cochrane偏倚风险评估工具和Jadad量表评价文献质量,采用Stata 14.0和RevMan 5.0软件进行进行方法学评价、异质性检验、敏感性分析、发表偏倚及经典与网络Meta分析;效应量采用相对危险度(RR)以及95%可信区间或预测区间(95%CI/95%PrI)、累积概率面积(SUCRA)表示。结果最终纳入文献13篇(敏感性分析已排除1篇文献),其中有1篇文献包含2个JTW配伍组,共涉及患者1040例;JTW纳入随机对照试验4个,而JTW+m∶n+BDZ纳入随机对照试验10个;最终整体数据及亚组分析数据均具有较好稳定性,且不存在异质性(P>0.1,I 2≤50%);而Begg秩相关分析和Egger线性回归分析均提示倒置漏斗图不对称,存在一定发表偏倚(Z=2.46,P<0.05;t=5.37,P<0.05)。经典Meta分析提示,与BDZ比较,JTW(RR=1.52,95%CI=[1.28,1.79])、JTW+m∶n+BDZ(RR=1.32,95%CI=[1.22,1.42])以及JTW+2∶1+BDZ(RR=1.33,95%CI=[1.14,1.54])、JTW+5∶1+BDZ(RR=1.22,95%CI=[1.09,1.37])、JTW+6∶1+BDZ(RR=1.44,95%CI=[1.20,1.74])、JTW+10∶1+BDZ(RR=1.36,95%CI=[1.14,1.60])治疗失眠临床有效率均显著提高。网络Meta分析预测区间提示,与BDZ组比较,JTW(RR=1.47,95%PrI=[1.16,1.87])、JTW+m∶n+BDZ(RR=1.28,95%PrI=[1.09,1.51])以及JTW+2∶1+BDZ(RR=1.33,95%PrI=[1.14,1.54])、JTW+6∶1+BDZ(RR=1.44,95%PrI=[1.12,1.85])、JTW+10∶1+BDZ(RR=1.31,95%PrI=[1.06,1.63])治疗失眠临床有效率均显著提高;SUCRA排序提示,JTW及JTW+m∶n+BDZ治疗失眠临床有效率总体排序是BDZ<JTW+m∶n+BDZ<JTW,而JTW+m∶n+BDZ(药味配伍)治疗失眠临床有效率排序是BDZ<JTW+5∶1+BDZ<JTW+10∶1Objective To systematically assess the efficacy of Jiaotai Pill(JTW)and its modified prescriptions(JTW+)plus benzodiazepines(BDZ)for insomnia by systematic review and network Meta-analysis,especially optimization ratio(m∶n)between Coptis chinensis and Cinnamo.Methods Randomized controlled trials(RCTs)regarding JTW and JTW++BDZ for insomina were comprehensively recruited in CNKI,VIP,Wanfang,and PubMed,Cochrane Library,EM-Base databases from their inception to December 31,2017.The risk of bias was assessed by the Cochrane collaboration's tool and Jadad scale.Systematic review and network-Meta analysis were performed to evaluate the relative risk(RR)plus 95%confidence interval(95%CI)or prediction interval(95%PrI),and surface under the cumulative ranking curves(SU-CRA)drawn by Stata 14.0 and RevMan 5.0 Software.Results A total of 13 RCTs(1 RCT was omitted by sensitivity a-nalysis)with 1040 patients included.Of them,one RCT included 2 JTW modified groups.There were 4 randomized control trials(RCTs)with JTW included,while 10 RCTs with JTW+m∶n+BDZ included.Overall heterogeneity were acceptable in both global data and subgroup analysis data(P>0.1,I 2<50%),but Begg's rank correlation analysis and Egger's linear regression analysis both suggested a publication bias(Z=2.46,P<0.05;t=5.37,P<0.05).Classical Meta-analysis showed that JTW(RR=1.52,95%CI=[1.28,1.79])and JTW+m∶n+BDZ(RR=1.32,95%CI=[1.22,1.42]),such as JTW+2∶1+BDZ(RR=1.33,95%CI=[1.14,1.54]),JTW+5∶1+BDZ(RR=1.22,95%CI=[1.09,1.37]),JTW+6∶1+BDZ(RR=1.44,95%CI=[1.20,1.74]),JTW+10∶1+BDZ(RR=1.36,95%CI=[1.14,1.60]),had more efficacy in improving the clinical efficacy of insomnia than BDZ.Network Meta-analysis displayed that JTW(RR=1.47,95%PrI=[1.16,1.87])and JTW+m∶n+BDZ(RR=1.28,95%PrI=[1.09,1.51]),such as JTW+2∶1+BDZ(RR=1.33,95%PrI=[1.14,1.54]),JTW+6∶1+BDZ(RR=1.44,95%PrI=[1.12,1.85]),JTW+10∶1+BDZ(RR=1.31,95%PrI=[1.06,1.63]),had more efficacy in improving the clinical efficacy of insomnia than BDZ;meanwhile,SUCRA suggested the best rank of JTW/JTW+(BDZ<JT

关 键 词：交泰丸 黄连 肉桂 配伍比例 失眠 随机对照试验 系统评价 网络Meta分析 

分 类 号：R256.23[医药卫生—中医内科学]