逍遥散治疗围绝经期综合征的系统评价和试验序贯分析  

A systematic evaluation and trial sequential analysis of Xiaoyao San on perimenopausal syndrome

作　　者：平丽鑫 俞赟丰 林凡 王颖 尹周安[1] 毛娅男[1] PING Lixin

机构地区：[1]湖南中医药大学,湖南长沙410208

出　　处：《中医临床研究》2022年第1期131-136,共6页Clinical Journal Of Chinese Medicine

基　　金：2018年度湖南中医药大学校级科研基金项目(99820001054);2018年度中医学一流学科课题(2018ZYX23)。

摘　　要：目的:系统评价逍遥散加减对比激素替代疗法治疗围绝经期综合征的有效性和安全性,为临床用药提供循证依据。方法:检索Wanfang、VIP、CNKI、CBM、PubMed、Embase、The Cochrane Library、Web of Science数据库,查找国内外公开发表的关于逍遥散加减治疗围绝经期综合征的随机对照试验,时限从建库至2020年8月。由2位研究员按照要求独立筛选文献,提取资料,评价偏倚风险,运用Revman5.3软件进行Meta分析,TSA 0.9软件进行试验序贯分析,Stata 15.0软件进行发表偏倚评估,GRADE 3.6软件进行证据质量评价。结果:共纳入11项研究,总样本量2 149例,试验组1 100例,对照组1 049例。(1)Meta分析:与激素替代疗法比较,逍遥散能够有效提高围绝经期综合征的临床总有效率[RR=1.17,95%CI=(1.10,1.24),Z=5.12,P <0.000 01],降低不良反应率[RR=0.21,95%CI=(0.17,0.26),Z=14.16,P <0.000 01]。(2)试验序贯分析:临床总有效率的累计Z值在第2项研究时达到了传统界值和TSA界值,不良反应率的累计Z值在第1项研究时穿过传统界值和TSA界值,校正结果与Meta分析结果一致,均可作为确切证据。(3)发表偏倚:Harbord检验显示临床总有效率和不良反应率的指标均不存在显著发表偏倚(P=0.70,P=0.94)。(4)证据质量:临床总有效率和不良反应率的证据质量等级均为中级,推荐强度均为弱推荐。结论:逍遥散加减治疗围绝经期综合征的有效性和安全性均优于激素替代疗法,具有在临床应用推广的价值,尤其适合具有激素治疗禁忌证的患者。Objective:The efficacy and safety of Xiaoyao San(逍遥散)and hormone replacement therapy in treating perimenopausal syndrome was systematically evaluated and compared,in order to provide evidence-based evidence for clinical medication.Methods:In domestic and foreign databases such as Wanfang,VIP,CNKI,CBM,PubMed,Embase,The Cochrane Library and Web of Science,the studies on randomized controlled trials of treating perimenopausal syndrome with Xiaoyao San from the establishment of the databases to August 2020 were retrieved.Two researchers independently screened the literature according to the requirements,extracted the data,and evaluated the risk of bias.Revman5.3 software was used for a meta-analysis,TSA 0.9 software was used to perform a trial sequential analysis,Stata 15.0 software was applied to execute publication bias assessment,and GRADE 3.6 software was used to perform evidence quality evaluation.Results:11 studies were included,with a total sample size of 2149,including 1100 cases in the experimental group and 1049 cases in the control group.The results of the Meta-analysis showed that compared with hormone replacement therapy,Xiaoyao San on perimenopausal syndrome can effectively improve the clinical total efficiency[RR=1.17,95%CI=(1.10,1.24),Z=5.12,P<0.00001],and reduce the adverse reaction[RR=0.21,95%CI=(0.17,0.26),Z=14.16,P<0.00001].The results of the trial sequential analysis showed that the cumulative Z value of the clinical total efficiency in the second study reached the traditional cut-off value and TSA threshold value,and the cumulative Z value of adverse reaction rate in the first study was out of the range of traditional boundary value and TSA boundary value.The correction results were consistent with the results of the meta-analysis,they both can be used as accurate evidence.According to the results of publication bias,the Harbor test showed that there was no significant publication bias in the clinical total efficiency and adverse reaction(P=0.70,P=0.94).The results of the evidence quality

关 键 词：逍遥散 围绝经期综合征 系统评价 META分析 试验序贯分析 

分 类 号：R271.116[医药卫生—中医妇科学]