目的 构建中医药治疗早发性卵巢功能不全(POI)核心指标集,规范POI中医药临床研究疗效评价指标体系.方法 检索 2017年1月1日至 2021年12月31日PubMed、Embase、Cochrane Library、Web of Science、中国知网(CNKI)、万方数据知识服务平台(WF)、维普资讯中文期刊服务平台(VIP)、中国生物医学文献服务系统(SinoMed)数据库获取文献,检索建库至2021年12月31日中国临床试验注册中心数据库、美国临床试验注册中心数据库获得临床试验注册方案,收集POI临床研究中使用的结局指标,采用半结构化访谈补充患者重视指标,构建结局指标条目池,通过德尔菲调查和共识会议筛选出核心指标.结果 共纳入554篇临床研究及14项临床试验注册方案,对20位患者进行半结构化访谈,指标合并整理后共纳入77种结局指标进入指标池,两轮德尔菲调查后初步纳入20个结局指标,通过专家共识会议最终形成的核心指标集为3个指标域的8个核心结局指标,包括卵巢储备功能(卵泡刺激素、雌二醇、抗苗勒管激素、窦卵泡计数)、月经相关指标(月经症状情况)和生育结局(妊娠率、活产率和获卵数).并通过专家讨论确定核心指标相应的测量方法及测量时间点.结论 本研究形成了中医药治疗POI临床研究核心指标集,实践了核心指标集制定方法,并以此为载体探索了中医药特色核心结局指标集的制定要点.
The Development of Core Outcome Set for Premature Ovarian Insufficiency Treated with Traditional Chinese Medicine
Objective To construct the core outcome set(COS)for premature ovarian insufficiency(POI)treated with traditional chinese medicine(TCM),thereby standardizing the effect evaluation system of POI clinical researches.Methods Databases including PubMed,EMbase,Cochrane Library,Web of Science,CNKI,Wanfang,VIP,SinoMed from January 2017 to December 31,2021,and Chinese Clinical Trials Registry(ChiCTR),ClinicalTrials.gov were searched to collect the outcomes used in clinical studies of POI.Supplemented with the patients preferred out-comes through semi-structured interviews,the outcome pool was then constructed.Finally through the Delphi survey and consensus conference,the COS for POI was obtained.Results A total of 554 clinical researches and 14 regis-tered clinical research protocols were included.A semi-structured interview was conducted within 20 patients.A total of 77 outcomes were included in the pool after consolidation.After two rounds of Delphi surveys,20 outcomes were initially included.The COS,which was finalized through expert consensus conference,consists of 8 outcomes in 3 domains,which were ovarian reserve function(follicle stimulating hormone,estradiol,anti-Mullerian hormone,sinus follicle count),menstruation-related indicators(menstrual symptoms condition)and fertility indicators(pregnancy rate,live birth rate and the numbers of retrieved oocytes).Through expert discussion,the corresponding measure-ment methods as well as the measurement time points of the COS were determined.Conclusion This study formed COS for clinical studies of TCM in the treatment of POI,by practicing the general method of developing COS,and exploring the key points of developing COS with TCM features.
premature ovarian insufficiencycore outcome settraditional Chinese medicine therapyclinical efficacy evaluation
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万方数据
