加减苍附导痰汤联合化学药对比单用化学药治疗多囊卵巢综合征疗效的Meta分析及试验序贯分析  

Meta-analysis and Trial Sequential Analysis of Therapeutic Efficacy of Modified Cangfu Daotan Decoction Combined with Chemical Medicine versus Chemical Medicine Alone in the Treatment of Polycystic Ovarian Syndrome

作　　者：谢蓬蓬[1,2] 谢铱子 纪树亮 孙伟鹏 孙治中 任悦怡 曾蕾 XIE Pengpeng;XIE Yizi;JI Shuliang;SUN Weipeng;SUN Zhizhong;REN Yueyi;ZENG Lei(The First Clinical College,Guangzhou University of TCM,Guangzhou 510405,China;Gynecology Dept.of TCM,Guangzhou Women and Children’s Medical Center,Guangzhou 510405,China;Office of Gynecological Department,the First Affiliated Hospital of Guangzhou University of TCM,Guangzhou 510405,China)

机构地区：[1]广州中医药大学第一临床医学院,广州510405 [2]广州市妇女儿童医疗中心中医妇科,广州510405 [3]广州中医药大学第一附属医院妇科办公室,广州510405

出　　处：《中国药房》2019年第5期698-703,共6页China Pharmacy

基　　金：国家自然科学基金资助项目(No.81804135)

摘　　要：目的:系统评价加减苍附导痰汤联合化学药对比单用化学药治疗多囊卵巢综合征(PCOS)的疗效,为临床决策提供循证参考。方法:计算机检索PubMed、Embase、Cochrane Library、中国期刊全文数据库、万方数据、中文科技期刊数据库和中国生物医学文献数据库,收集加减苍附导痰汤联合化学药[炔雌醇环丙孕酮(达英-35)、克罗米芬、二甲双胍(]试验组)对比单用化学药(对照组)治疗PCOS的随机对照试验(RCT),对符合标准的文献进行资料提取,并采用Cochrane 5.1.0偏倚风险评估工具和改良Jadad量表进行质量评价后,采用Stata 14.0软件对总有效率、血清激素水平[血清卵泡刺激素(FSH)、血清促黄体生成素(LH)、血清促黄体生成素/卵泡刺激素(LH/FSH)、睾酮]、体质量指数(BMI)、排卵率及体征(多毛、痤疮)评分等指标进行Meta分析,并采用TSA0.9软件进行试验序贯分析。结果:共纳入20项RCT,合计1 484例患者。Meta分析结果显示,试验组患者总有效率[RR=1.13,95%CI(1.02,1.24),P<0.05]、血清激素水平{FSH[WMD=-0.59,95%CI(-0.98,-0.20),P<0.05]、LH[WMD=-0.95,95%CI(-1.41,-0.52),P<0.05]、LH/FSH[WMD=-1.04,95%CI(-1.78,-0.33),P<0.05]、睾酮[WMD=-0.93,95%CI(-1.38,-0.28),P<0.05]}、BMI指数[SMD=-1.01,95%C(I-1.76,-0.27),P<0.05]、排卵率[RR=1.17,95%C(I1.02,1.34),P<0.05]及体征{多毛[WMD=-0.48,95%CI(-0.86,-0.10),P<0.05]、痤疮[WMD=-1.16,95%CI(-1.56,-0.75),P<0.05]}评分均优于对照组,差异均有统计学意义;试验序贯分析结果显示,加减苍附导痰汤联合化学药治疗PCOS治疗效果证据可靠。结论:对比单用化学药治疗PCOS,加减苍附导痰汤联合化学药可提高总有效率和排卵率,降低血清激素水平、BMI指数及体征评分。OBJECTIVE:To systematically evaluate therapeutic efficacy of modified Cangfu daotan decoction(MCDD)combined with chemical medicine versus chemical medicine alone in the treatment of polycystic ovarian syndrome(PCOS),and to provide evidence-based reference for clinical decision.METHODS:Retrieved from PubMed,Embase,Cochrane Library,CJFD,Wanfang database,VIP and CBM,randomized controlled trials(RCTs)about MCDD combined with chemical medicine[ethynestradiol cycloprogesterone(Diane-35),clomiphene,metformin](trial group)versus chemical medicine alone(control group)in the treatment of PCOS were collected.After data extraction and quality evaluation with Cochrane 5.1.0 bias risk evaluation tool and Jadad scale,Meta-analysis was conducted for total response rate,serum hormone level(FSH,LH,LH/FSH,testosterone),BMI,ovulation rate and physical signs(hirsutism,acne)by using Stata 14.0 software.Trial sequential analysis(TSA)was conducted by using TSA 0.9 software.RESULTS:A total of 20 RCTs were included,involving 1 484 patients.Results of Meta analysis showed that total response rate[RR=1.13,95%CI(1.02,1.24),P<0.05],serum hormone level{FSH[WMD=-0.59,95%CI(-0.98,-0.20),P<0.05],LH[WMD=-0.95,95%CI(-1.41,-0.52),P<0.05],LH/FSH[WMD=-1.04,95%CI(-1.78,-0.33),P<0.05],testosterone[WMD=-0.93,95%CI(-1.38,-0.28),P<0.05]},BMI[SMD=-1.01,95%CI(-1.76,-0.27),P<0.05],ovulation rate[RR=1.17,95%CI(1.02,1.34),P<0.05]and physical signs{hirsutism[WMD=-0.48,95%CI(-0.86,-0.10),P<0.05],acne[WMD=-1.16,95%CI(-1.56,-0.75),P<0.05]}of trial group were all better than those of control group,with statistical significance.TSA showed that there are reliable evidences for MCDD combined with chemical medicine in the treatment of PCOS.CONCLUSIONS:Versus chemical medicine alone in the treatment of PCOS,MCDD combined with chemical medicine can improve total response rate and ovulation rate,reduce serum hormone levels,BMI and physical signs.

关 键 词：多囊卵巢综合征 化学药 加减苍附导痰汤 疗效 META分析 试验序贯分析 

分 类 号：R286[医药卫生—中药学]