Zhou Mi, Li Jieyun, Xiao Xinang, Lim Jiekee, Xu Zhaoxia
School of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
Shanghai Key Laboratory of Health Identification and Assessment, Shanghai, People's Republic of China.
Int J Gen Med. 2024 Aug 16;17:3575-3590. doi: 10.2147/IJGM.S473899. eCollection 2024.
To analyse the current status of outcome indicators in randomised controlled trials (RCTs) of traditional Chinese medicine (TCM) for the treatment of coronary heart disease (CHD) with deficiency of qi and yin, and to provide a basis for constructing a core indicator set (COS) for TCM treatment of CHD.
We searched the database of China National Knowledge Infrastructure (CNKI), PubMed,etc. 8 databases in the last 5 years. RCTs of TCM for CHD included in core journals were evaluated for the risk of bias of the included studies, and the current status of the selection of outcome indicators was statistically analysed.
A total of 39 RCTs with a sample size of 44~398 cases were included, and 164 outcome indicators were reported, with a frequency of 383 applications. The outcome indicators were categorised into 6 indicator domains according to their functional attributes, which were, in descending order, safety indicators, physicochemical examination, effective rate, economic assessment, disease evidence score, and quality of life. The top 3 indicators in terms of frequency of application of outcome indicators were safety indicators, physical and chemical examination indicators, and efficiency, among which electrocardiogram, inflammation indicators, and clinical efficacy were the most frequently used; there were many different types of measurement tools for outcome indicators, among which total efficiency and TCM symptom points were the most frequently used; the time point of measurement was not the same.
The RCTs of TCM for CHD in the last 5 years have many shortage in the selection of outcome indicators, and should actively promote the construction of the COS of TCM for CHD.
分析中医药治疗冠心病气阴两虚证随机对照试验（RCT）中结局指标的现状，为构建中医药治疗冠心病的核心指标集（COS）提供依据。
检索中国知网（CNKI）、PubMed等8个数据库近5年的文献。对核心期刊收录的中医药治疗冠心病的RCT进行纳入研究的偏倚风险评价，并对结局指标的选取现状进行统计分析。
共纳入样本量为44~398例的39项RCT，报道结局指标164个，应用频次383次。结局指标按功能属性分为6个指标领域，依次为安全性指标、理化检查、有效率、经济学评价、疾病证据评分、生活质量。结局指标应用频次前3位的是安全性指标、理化检查指标、疗效，其中心电图、炎症指标、临床疗效应用最为频繁；结局指标测量工具类型多样，其中总有效率和中医症状积分应用最为频繁；测量时间点不一。
近5年中医药治疗冠心病的RCT在结局指标选取方面存在诸多不足，应积极推进中医药治疗冠心病COS的构建。
