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血府逐瘀汤加减联合西药治疗子宫肌瘤的系统评价及序贯Meta分析
引用本文:曾蕾,纪树亮,陈惠琪,罗颂平.血府逐瘀汤加减联合西药治疗子宫肌瘤的系统评价及序贯Meta分析[J].中国中药杂志,2021(1):225-236.
作者姓名:曾蕾  纪树亮  陈惠琪  罗颂平
作者单位:广州中医药大学第一附属医院妇儿中心&广州中医药大学岭南医学研究中心;广州中医药大学第一临床医学院;广州中医药大学第二临床医学院;广州中医药大学第一附属医院
基金项目:国家自然科学基金项目(81804135);2019年罗元恺滋肾育胎丸中青年科研基金项目(20190802);中国中西医结合妇产科专项研究基金华润三九专项项目;罗颂平广东省名中医传承工作室建设项目(粤中医办函[2019]5号);国家中医药管理局全国中医学术流派传承工作室“岭南罗氏妇科传承工作室”建设项目(国中医药人教函[2019]62号);邓高丕广东省名中医传承工作室建设项目(粤中医办函[2019]5号)。
摘    要:计算机检索中国知网、PubMed等数据库,提取符合标准的血府逐瘀汤加减联合西药(试验组)对比单用西药(对照组)治疗子宫肌瘤的随机对照试验(RCT),共纳入25项研究,2328例患者。使用Cochrane Handbook 5.1.0中的偏倚风险评估工具进行质量评价。使用Stata 14.0软件对报告指标进行Meta分析,包括总有效率、血清激素水平孕酮(P),促黄体生成素(LH),雌二醇(E2),促卵泡素(FSH)]、子宫体积、子宫肌瘤体积及不良反应发生率。结果显示,试验组患者总有效率(RR=1.21,95%CI1.17,1.25],P<0.05)显著优于对照组;血清激素水平(WMDP=-3.86,95%CI-4.31,-3.41],P<0.05;WMDLH=-3.64,95%CI-4.47,-2.82],P<0.05;WMDE2=-39.99,95%CI-53.45,-26.52],P<0.05;WMDFSH=-3.79,95%CI-4.86,-2.72],P<0.05)、子宫体积(WMD=-50.02,95%CI-55.98,-44.06],P<0.05)、子宫肌瘤体积(WMD=-15.79,95%CI-18.11,-13.46],P<0.05)及不良反应发生率(RR=0.65,95%CI0.48,0.88],P<0.05)均较对照组显著降低,差异均有统计学意义。使用TSA 0.9软件进行序贯分析,结果显示试验组疗效证据可靠。该研究表明,血府逐瘀汤加减联合西药的治疗方案较仅用西药疗效更优,未来尚需更多高质量研究加以验证。

关 键 词:子宫肌瘤  米非司酮  血府逐瘀汤加减  疗效  META分析  序贯分析

Systematic evaluation and sequential Meta-analysis of modified Xuefu Zhuyu Decoction combined with Western medicine in treatment of leiomyoma
ZENG Lei,JI Shu-liang,CHEN Hui-qi,LUO Song-ping.Systematic evaluation and sequential Meta-analysis of modified Xuefu Zhuyu Decoction combined with Western medicine in treatment of leiomyoma[J].China Journal of Chinese Materia Medica,2021(1):225-236.
Authors:ZENG Lei  JI Shu-liang  CHEN Hui-qi  LUO Song-ping
Institution:(Maternity and Child Center,the First Affiliated Hospital of Guangzhou University of Chinese Medcine,Lingnan Medical Research Center,Guangzhou University of Chinese Medicine,Guangzhou 510405,China;the First Clinical College,Guangzhou University of Chinese Medcine,Guangzhou 510405,China;the Second Clinical College,Guangzhou University of Chinese Medcine,Guangzhou 510405,China;the First Affiliated Hospital of Guangzhou University of Chinese Medcine,Guangzhou 510405,China)
Abstract:CNKI,PubMed and other databases were retrieved to extract eligible randomized controlled trial(RCT)about modified Xuefu Zhuyu Decoction(MXZD)combined with Western medicine(trial group)versus Western medicine alone(control group)in the treatment of leiomyoma.Therefore,a total of 25 RCTs were included,involving 2328 patients.Bias risk evaluation tool in Cochrane Handbook 5.1.0 was used for evaluating the quality of these RCTs.Meta-analysis was performed for the reported indicators,including total efficiency,serum hormone levelprogesterone(P),luteinizing hormone(LH),estradiol(E2),follicle stimulating hormone(FSH)],uterine size,fibroids size and adverse reactions by using Stata 14.0 software.Meta-analysis showed that the total efficiency(RR=1.21,95%CI1.17,1.25],P<0.05)of trial group was better than that of control group.Serum hormone level(WMDP=-3.86,95%CI-4.31,-3.41],P<0.05;WMDLH=-3.64,95%CI-4.47,-2.82],P<0.05;WMDE2=-39.99,95%CI-53.45,-26.52],P<0.05;WMDFSH=-3.79,95%CI-4.86,-2.72],P<0.05),uterine size(WMD=-50.02,95%CI-55.98,-44.06],P<0.05),fibroids size(WMD=-15.79,95%CI-18.11,-13.46],P<0.05)and adverse reactions(RR=0.65,95%CI0.48,0.88],P<0.05)of trial group were all lower than those of control group,with statistical significances.Trial sequential analysis(TSA)was performed by using TSA 0.9 software,and showed a reliable therapeutic effect of the experimental group.In short,our study indicated that modified Xuefu Zhuyu Decoction combined with Western medicine had a better therapeutic effect on leiomyoma than Western medicine alone,but more high-quality studies are needed to verify this conclusion in the future.
Keywords:leiomyoma  mifepristone  modified Xuefu Zhuyu Decoction  therapeutic efficacy  Meta-analysis  sequential analysis
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