稳定型心绞痛中医药临床试验指标测量路径

Outcome measures in clinical trials of traditional Chinese medicine for stable angina pectoris

临床试验的结果对于确定治疗效果非常重要。然而,对于中医药临床试验中结局的选择却知之甚少,本工作旨在对中医药临床试验中用于稳定型心绞痛患者的结局指标进行描述性分析,并为临床研究提供基线数据。为相关临床试验开发核心结果集。检索了医学数据库,确定了2010年发表的关于中医治疗稳定型心绞痛效果的随机试验。总共确定了94项随机试验(涉及9,111名参与者),涉及79种不同的结果。结果的平均数量为5(范围:每次试验1-21)。最常报告的五个结局为心电图有效率、心绞痛有效率、中医证候有效率、空腹血脂指标、硝酸甘油停药率。确定了几个挑战:1)结果的显着异质性以及相同结果的测量技术和时间的差异;2)将连续数据转换为分类数据并在>90%的试验中如此呈现;3)与中医优势和特点相关的结果的试验很少;4)结果的选择性报告。所使用的结果过于异质,并且某些测量结果(时间和技术)的选择令人困惑或不恰当。因此,为了提高一致性,制定和实施核心成果集是必要的。

Objective:This work aimed to present a descriptive analysis of the outcome measures used in clinical trials of traditional Chinese medicine(TCM)for patients with stable angina pectoris,and to provide baseline data for the development of core outcome sets(COSs)for relevant clinical trials.Methods:Medical databases were searched to identify randomized trials of the effects of TCM for the treatment of stable angina pectoris.Outcome measures of each trial were extracted.Descriptive statistics were used to analyze the baseline characteristics of outcomes in clinical trials of TCM.Results:94 randomized trials(with 9,111 participants)involving 79 different outcomes were identified.The mean number of outcomes was 5(1-21 per trial).The 5 most commonly reported outcomes were efficacy rate of electrocardiogram,efficacy rate of angina pectoris,efficacy rate of TCM syndrome,fasting lipid indices,and withdrawal rate of nitroglycerin.Several challenges were identified:(1)significant heterogeneity of outcomes and differences in the technique and timing of the measurement of the same outcome;(2)transformation of continuous data into categorical data and presented as such in>90% of trials;(3)few trials on the outcomes associated with the advantages and characteristics of TCM;and(4)selective reporting of outcomes.Conclusions:The outcomes used are excessively heterogenous,and the choice of some outcomes(timing and techniques)for measurement is confusing or inappropriate.Hence,developing and implementing a COS is necessary for greater consistency.