实用性临床试验在中医疗效评价中的应用-中国中西医结合杂志.PDF

中国中西医结合杂志 2010 年 12 月第 30 卷第 12 期 CJITWM December 2010 Vol. 30 No. 12 • • , , , 1241 •  临床试验方法学  • 实用性临床试验在中医疗效评价中的应用 武轶群  胡永华 摘要 循证医学提出后，寻找并产生合适的证据成为中医疗效评价的关键。随机对照试验（RCT ） 是目前公认的医学干预评价的金标准，但传统随机对照试验（解释性临床试验，ECT ）并不适合中医个性 化治疗的特点。中医学理论形成和发展基于大量临床经验，评价其临床效果和安全性是首要任务。由于 中医治疗措施的复杂性和个体化，中医疗效所体现的是一个受到环境影响的复杂体系。实用性临床试验 （PCT ）的特点正适合于中医药这种复杂医疗干预体系的评价。本文将讨论PCT在中医疗效评价中的可行 性，探索一种中医疗效评价的新思路。 关键词 实用性临床试验；中医疗效；临床试验 Application of Pragmatic Clinical Trials in Clinical Evaluation of Chinese Medicine WU Yi-qun and HU Yong-hua Department of Epidemiology and Biostatistics, Health Science Center, Peking University, Beijing (100191) ABSTRACT Since the evidence-based medicine (EBM) being evoked widely, to seek out the best evidence is becoming the pivotal step for the development of Chinese medicine (CM), and randomized controlled trial (RCT, at most times, it means explanatory clinical trial—ECT) has been accepted as the general golden standard for the evaluation of clinical intervention. However, it is noted that the traditional RCT (ECT) is unsuitable for the special characteristics of individual treatment in CM. The formation and development of CM theory is found on large amount of clinical experiences, and to evaluate its clinical efficacy and safety is the most primary task. Because the CM intervention measures are complex and individualized, the clinical effectiveness of CM is embodied as a complex system, which impacted greatly by the environment factors. It is deemed that the pragmatic clinical trial (PCT) has the character just fitting for the evaluation. The feasibility of PCT in CM clinical evaluation is discussed in this paper in order to raise a new issue for the evaluation of CM effectiveness. KEYWORDS pragmatic