针刺治疗多囊卵巢综合征随机对照试验的结局指标现状分析

Analysis of status quo on the outcome indexes in randomized controlled trials of acupuncture for polycystic ovary syndrome

目的:分析针刺治疗多囊卵巢综合征(PCOS)随机对照试验(RCT)结局指标的应用情况及现状,为核心结局指标集的构建提供有益参考。方法:检索中国期刊全文数据库(CNKI)、万方数据知识服务平台(Wanfang)、维普资讯中文期刊服务平台(VIP)、中国生物医学文献数据库(Sino Med)、PubMed、EMbase、Cochrane Library及Web of Science数据库2018年1月1日至2023年6月28日收录的针刺治疗PCOS的临床研究,提取、归纳和分析相关结局指标,整理针刺治疗PCOS的指标域。结果:共纳入60篇文献,涉及123个结局指标。结局指标以理化检测(65.79%)使用频次最高,其次是症状/体征(23.37%)、安全性事件(4.02%)、中医病证(3.10%)、生活质量(1.86%)、远期预后(1.86%),所有文献均未纳入经济学评估指标。结局指标现状存在无主次要结局指标之分、种类繁多、疗效评定标准不一、忽视生活质量评价及安全性评价等问题。结论:针刺治疗PCOS的RCT结局指标的现状不利于将不同研究数据及结果进行汇总和比较。建议构建符合中医治疗特色的核心指标集,以提高针灸临床研究设计的规范性和证据质量。

Objective To analyze the application and status quo of the outcome indexes in randomized controlled trials(RCTs)of acupuncture for polycystic ovary syndrome(PCOS)so as to provide a favorable reference for the construction of the core outcome set.Methods RCTs of acupuncture for PCOS were searched in databases,i.e.CNKI,Wanfang,VIP,SinoMed,PubMed,EMbase,Cochrane Library and Web of Science,from January 1st,2018 to June 28th,2023.The relevant outcome indexes were extracted,collected and analyzed to collate the index domains of acupuncture for PCOS.Results A total of 60 articles were included,involving 123 outcome indexes.The outcome indexes of the physical and chemical detection were the highest in frequency(65.79%),followed by the symptoms/signs(23.37%),safety events(4.02%),TCM syndrome(3.10%),quality of life(1.86%)and the long-term prognosis(1.86%).None of the RCTs included the indexes for the economic evaluation.Regarding the status quo of outcome indexes,the primary outcome index was not distinguished from secondary one,the types of outcome indexes were various,the effect evaluation was not specified,and the assessment of quality of life and safety was ignored.Conclusion The status quo of the outcome indexes in RCTs of acupuncture for PCOS is not conducive to pooling and comparing the data and the results among the different trials.It is recommended to structure the core outcome index set consistent with the therapeutic characteristics of TCM so as to improve the standardization of the clinical design of acupuncture and the quality of evidence in the trials.