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作 者:张欣颖 魏嘉茵 潘婕 韩千禧 杨倩 朱文涛[1] ZHANG Xinying;WEI Jiayin;PAN Jie;HAN Qianxi;YANG Qian;ZHU Wentao(School of Management,Beijing University of Chinese Medicine,Beijing 100029)
出 处:《药物评价研究》2024年第1期160-170,共11页Drug Evaluation Research
基 金:中央高校基本科研业务专项资助项目(2020-JYB-ZDGG-072)。
摘 要:目的 系统评价丹莪妇康煎膏治疗子宫内膜异位症及其术后的有效性和安全性。方法 计算机检索中国学术期刊全文数据库(CNKI)、万方数据库(WanfangData)、维普中文科技期刊数据库(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Cochrane Library和Web of Science数据库中,关于丹莪妇康煎膏治疗子宫内膜异位症的随机对照试验(RCT),检索时限为建库起至2023年9月3日。通过Cochrane偏倚风险评估工具评估文献质量,采用RevMan 5.4.1软件进行Meta分析。结果 共纳入21个RCTs,Meta分析结果显示:单独使用丹莪妇康煎膏治疗子宫内膜异位症的临床总有效率[RR=1.07, 95%CI (1.01, 1.13), P=0.01]、疼痛视觉模拟量表(VAS)评分[MD=-1.59, 95%CI (-2.70,-0.47),P=0.005]、血清糖类抗原125(CA125)[MD=-5.91,95%CI(-8.85,-2.97),P<0.000 01]均优于单独使用孕三烯酮,差异均具有统计学意义;单独使用丹莪妇康煎膏治疗子宫内膜异位症的临床总有效率[RR=1.23,95%CI(0.91,1.65),P=0.18]优于单独使用米非司酮,差异无统计学意义。单独使用丹莪妇康煎膏治疗子宫内膜异位症的不良事件发生率[MD=0.18,95%CI(0.10,0.32),P<0.000 001]低于单独使用孕三烯酮,差异具有统计学意义。结论 丹莪妇康煎膏治疗子宫内膜异位症具有较好的有效性和安全性。Objective To evaluate the efficacy and safety of Dan′e Fukang Decoction in the treatment of endometriosis(EMs).Methods Databases such as CNKI,Wangfang Data,VIP,SinoMed,PubMed,Cochrane Library and Web of Science were searched by computer for randomized controlled trials(RCT)of Dan′e Fukang Decoction in the treatment of EMs from database establishment to September 3,2023.After literature screening,evaluate literature quality by Cochrane information extraction and deviation risk included in the evaluation study,Meta-analysis was performed using RevMan 5.4.1 software.Results A total of 21 RCTs were included.Meta-analysis showed that Dan′e Fukang Decoction was superior to gastronome in the clinical response rate of Ems[RR=1.07,95%CI(1.01,1.13),P=0.01],pain visual analogue scale(VAS)score[MD=−1.59,95%CI(−2.70,−0.47),P=0.005],serum cancer antigen CA125 level[MD=−5.91,95%CI(−8.85,−2.97),P<0.00001],and the differences were statistically significant;Dan′e Fukang Decoction was superior to mifepristone in the clinical response rate of Ems[RR=1.23,95%CI(0.91,1.65),P=0.18].The incidence of adverse events in EMs treated with Dan′e Fukang Decoction alone[MD=0.18,95%CI(0.10,0.32),P<0.000001]was lower than that with gestrinone alone,and the difference was statistically significant.Conclusion Dan′e Fukang Decoction has good efficacy and safety in the treatment of EMs.
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