摘要
[目的]通过分析评价中医药治疗痛风性关节炎(GA)的随机对照试验(RCT)的结局指标现状,为临床开展高质量研究和构建核心结局指标集提供参考与帮助。[方法]全面检索8个数据库,包括4个中文数据库(中国知网、维普资讯中文期刊服务平台、万方数据知识服务平台、中国生物医学文献服务系统);4个英文数据库(Cochrane Library、EMbase、PubMed、Web of Science),检索时限为建库至2024年7月16日,根据纳入排除标准筛选相关RCT,依据Cochrane偏倚风险评估工具对纳入研究进行偏倚风险评价。[结果]最终纳入77项RCTs,样本量40~474例,涉及123种结局指标,总频数668次,包括理化检测类320次(46.51%)、症状/体征类202次(30.24%)、安全性事件类96次(14.37%)、中医症状/证候类25次(3.74%)、远期预后类12次(1.80%)、其他类10次(1.50%)、生活质量类3次(0.45%)、经济学评价指标缺乏。[结论]目前的临床研究在结局指标方面存在试验设计不完善,未明确设定主要结局指标,结局指标种类繁多且缺乏系统性,对多项关键指标的关注不足以及中医药特色指标未能规范化等问题。建议提升研究设计的科学性,融合中医药的独特疗效与临床研究需求,以建立一套符合中医药特色的核心指标体系。
[Objective]This study evaluates the current status of outcome indicators in randomized controlled trial(RCT)for traditional Chinese medicine treatment of gouty arthritis(GA)and provides reference for clinical research and the construction of a core outcome set reference and support.[Methods]Eight databases were comprehensively searched,including four Chinese-language databases(CNKI,VIP,Wanfang Data,SinoMed)and four English databases(Cochrane Library,EMbase,PubMed,Web of Science)up to July 16,2024.Relevant RCTs were screened according to the inclusion and exclusion criteria,and the quality of the included trials was evaluated by the Cochrane risk-of-bias tool.[Results]Seventy-seven RCTs were finally included,with sample sizes ranging from 40 to 474 cases.There were 123 types of outcome indicators,with a total frequency of 668 times,including 320 for laboratory tests(46.51%),202 for symptoms/signs(30.24%),96 for safety events(14.37%),25 for traditional Chinese medicine symptoms/syndromes(3.74%),12 for long-term prognosis(1.80%),10 for others(1.50%),and 3 for quality of life(0.45%),but economic evaluation indicators were lacking.[Conclusion]The current clinical research on outcome indicators had a variety of problems,such as imperfect trial design,unclearly defined primary outcome indicators,has a wide variety of outcome indicators but lack of systematicity,lack of attention to a number of key indicators,and failure to standardize the traditional Chinese medicine-specific indicators.It is recommended to enhance the scientific nature of research,integrate the unique efficacy of traditional Chinese medicine with clinical research needs,and establish a set of key indicator systems that align with the characteristics of traditional Chinese medicine.
作者
张雯
刘涵驰
孙天昊
单心觉
吴深涛
ZHANG Wen;LIU Hanchi;SUN Tianhao;SHAN Xinjue;WU Shentao(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China;National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China;Graduate School,Beijing University of Chinese Medicine,Beijing 100029,China;China Academy of Chinese Medical Science Guang’anmen Hospital,Beijing 100053,China)
出处
《天津中医药》
2025年第8期1011-1019,共9页
Tianjin Journal of Traditional Chinese Medicine
基金
国家中医药管理局全国名老中医药专家传承工作室建设项目(国中医药人教函[2022]75号)
天津市南开区中医药传承创新发展示范试点项目(20240206002)。
关键词
痛风性关节炎
中医药
随机对照试验
结局指标
核心指标集
gouty arthritis
traditional Chinese medicine
randomized controlled trial
outcome measures
core outcome set
作者简介
张雯(1999-),女,硕士研究生在读,主要从事内分泌代谢性疾病相关临床研究;通讯作者:吴深涛,E-mail:shtaowu@163.com。
