摘要
目的:通过系统分析中医药治疗急性气管-支气管炎随机对照试验(RCT)结局指标应用现状,为急性气管-支气管炎中医临床试验设计提供参考。方法:计算机检索近10年8个中英文数据库和2个临床试验注册中心收录的中医药治疗急性气管-支气管炎RCT,由2名研究者独立进行文献筛选、资料提取和偏倚风险评估,系统分析结局指标应用情况。结果:共纳入77项研究,涉及57种结局指标,出现频次417次,前5位结局指标依次为临床疗效、不良事件、中医证候积分、咳嗽症状积分和安全性指标。50项报告了西医诊断标准,42项报告了中医辨证参考标准,19项报告了主要结局指标,5项报告了中医证候疗效评价标准。结论:结局指标应用主要存在主要与次要结局指标欠明确、中医辨证参考标准及证候疗效评价标准不统一、安全性与经济学指标报告不充分以及患者报告结局指标关注不足等问题。建议今后开展临床试验时明确区分主要与次要结局指标,合理选择中医辨证标准,科学建立证候疗效评价标准,重视安全性与经济学指标,关注患者报告结局指标。
Objective:To provide a reference for the design of traditional Chinese medicine(TCM) clinical trials for acute tracheobronchitis by systematically analyzing the current application of outcome measures in randomized controlled trials(RCTs) of TCM treatment for this condition.Methods:A computer-based search was conducted across eight Chinese and English databases and two clinical trial registries for RCTs of TCM treatment for acute tracheobronchitis published over the past ten years.Two researchers independently performed literature screening,data extraction,and risk-of-bias assessment,followed by a systematic analysis of the application of outcome measures.Results:A total of 77 studies were included,involving 57 types of outcome measures reported 417 times in total.The top five most frequently used outcomes were clinical efficacy,adverse events,TCM syndrome score,cough symptom score,and safety indicators.Fifty studies reported Western medicine diagnostic criteria,42 studies reported TCM syndrome differentiation criteria,19 studies specified primary outcome measures,and only 5 studies reported standards for evaluating the efficacy of TCM syndromes.Conclusion:The application of outcome measures revealed several issues,including unclear distinction between primary and secondary outcomes,inconsistency in TCM syndrome differentiation and efficacy evaluation standards,insufficient reporting of safety and economic indicators,and inadequate attention to patient-reported outcomes.It is recommended that future clinical trials clearly differentiate primary and secondary outcomes,reasonably select TCM syndrome differentiation standards,establish scientific criteria for evaluating TCM syndrome efficacy,and emphasize the reporting of safety,economic,and patient-reported outcome indicators.
作者
刘梦娟
王佳佳
李春阳
王露
张心怡
李建生
LIU Mengjuan;WANG Jiajia;LI Chunyang;WANG Lu;ZHANG Xinyi;LI Jiansheng(Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province&Education Ministry of P.R.China/Henan Key Laboratory of Chinese Medicine for Respiratory Diseases,Henan University of Chinese Medicine,Zhengzhou 450046,China;Department of Respiratory Diseases,The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450003,China;The First Clinical Medical School,Henan University of Chinese Medicine,Zhengzhou 450003,China)
出处
《世界中医药》
北大核心
2025年第6期966-974,共9页
World Chinese Medicine
基金
国家自然科学基金项目(81830116)
河南省中医药科学研究专项(2023ZY2039)
河南省卫生健康委国家中医药传承创新中心科研专项(2023ZXZX1126)
河南省“双一流”创建学科中医学科学研究专项(HSRP-DFCTCM-2023-4-09)
河南省高等学校重点科研计划项目(25A360010)。
关键词
急性气管-支气管炎
中医药
随机对照试验
主要结局指标
次要结局指标
证候诊断
疗效评价
现状
Acute tracheobronchitis
Traditional Chinese medicine
Randomized controlled trial
Primary outcomes
Secondary outcomes
Syndrome diagnosis
Efficacy evaluation
Current situation
