中医药治疗乳腺增生症随机对照试验结局指标分析  

Outcome Indicators in Randomized Controlled Trials on Treating Hyperplasia of Mammary Glands by Traditional Chinese Medicine

作　　者：张家瑞 武红莉[2] 樊英怡 ZHANG Jia-rui;WU Hong-li;FAN Ying-yi(Department of Breast Surgery,Beijing University of Traditional Chinese Medicine Third Affiliated Hospital,Beijing 100029;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700)

机构地区：[1]北京中医药大学第三附属医院乳腺外科,北京100029 [2]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《世界中西医结合杂志》2025年第3期452-460,共9页World Journal of Integrated Traditional and Western Medicine

基　　金：首都卫生发展科研专项项目(首发2018-3-7031)。

摘　　要：目的分析近五年发表的中医药治疗乳腺增生症(Hyperplasia of mammary glands,HMG)的随机对照试验(Randomized controlled trial,RCT)结局指标,为中医药治疗乳腺增生症的核心指标集的构建奠定基础。方法计算机检索中国知网(CNKI)、万方数据知识服务平台(WanFang)、维普网(VIP)、中国生物医学文献服务系统(Sinomed)、Pubmed、Cochrane Library和Web of Science数据库自2019年1月1日—2024年5月20日期间的中医药治疗乳腺增生症的随机对照试验,根据纳入、排除标准筛选文献,统计文献基本信息及结局指标信息。结果共纳入175项RCTs,包含18499例患者。涉及中医病证、症状/体征、影像学检查、理化检测、安全性事件、生活质量、远期预后、经济学评估及其他共9类105种结局指标。使用频次排名前五的结局指标有:症状疗效(90.86%)、总有效率(90.86%)、最大肿块直径(67.43%)、雌二醇(Estradiol,E2)(51.43%)、不良反应(50.86%)。结论目前中医药治疗HMG的RCT结局指标存在指标数量与组合选择差异大、疗效评价标准模糊不统一、结局指标中医特色不足、相同指标测量方式差异大、指标测量时间点不统一、随访及远期预后缺乏关注以及经济学评估缺乏、安全性事件报告不清晰等问题。需要制订更为完善的指标集,明确最核心指标,以提高中医药研究的质量。Objective To analyze the outcome indicators in randomized controlled trials(randomized controlled trial,RCT)on treating hyperplasia of mammary glands(HMG)by Traditional Chinese Medicine(TCM)published in the past five years,to lay a foundation for the construction of the core outcome set of TCM in the treatment of HMG.Methods Randomized controlled trials on treating HMG by TCM from January 1,2019 to May 20,2024 were searched on China Knowledge Infrastructure(CNKI),Wanfang data(WanFang),VIP Network(VIP),Sinomed,Pubmed,Cochrane Library and Web of Science database.The basic information and outcome indicator information of the literature was selected according to the inclusion and exclusion criteria.Results A total of 175 RCTs involving 1,8499 patients were included,covering TCM syndrome,symptoms/signs,imaging examination,physicochemical examination,safety incidents,quality of life,long-term prognosis,economic evaluation,as well as other 9 categories and 105 outcome indicators.The top five frequently used outcome indicators were:efficacy(90.86%),total effective rate(90.86%),maximum mass diameter(67.43%),estradiol(E2)(51.43%),and adverse reactions(50.86%).Conclusion At present,there are some problems in the RCT outcome indicator of treating HMG by TCM,including great differences in the number of indicators and combination selection,ambiguous and inconsistent evaluation criteria for efficacy,lack of TCM characteristics in outcome indicators,significant difference in measurement method of the same indicator,inconsistent measurement time,lack of attention to follow-up and long-term prognosis,lack of economic evaluation,inadequate reporting of safety incidents.Therefore,it is necessary to formulate a more perfect outcome set and clarify the core indicators to improve the quality of TCM research.

关 键 词：中医药 乳腺增生症 随机对照试验 结局指标 核心指标集 

分 类 号：R655.8[医药卫生—外科学]