中国循证医学杂志

中国循证医学杂志

母方案设计用于冠心病中医药防治方案循证优化的思路和实施方法

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母方案(master protocol)的提出与实施是临床试验的一次重大变革,因其完善的试验网络、合理的试验设计和创新的统计分析方法,成为使用更少的临床资源获得更多医学信息的高效率临床试验新模式,其已在临床肿瘤研究中取得不错的成绩。本文结合辨证论治的特点,探讨将母方案试验设计应用于中医药临床研究,以“冠心病、心绞痛-心肌梗死-心力衰竭”的临床试验设计为例,为中医临床研究的同证候系疾病的母方案设计提供新方法和新思路。

Master protocol is a great transformation of clinical trials with complete research network, reasonable design and innovative statistical analysis methods. It is a high-efficiency new model of clinical trials which could get more medical information with less clinical resources. Clinical researches in the field of oncology using master protocol have already made delightful achievements. This paper introduces the design of clinical trials about angina pectoris of coronary heart disease, myocardial infarction and heart failure for instance and discusses the application of master protocol to clinical researches of Traditional Chinese Medicine combined with the differentiation of syndromes and treatments. We expect to provide new ideas and methods for the design of master protocol about diseases with the same syndrome pattern series of Traditional Chinese Medicine.

关键词: 母方案; 临床研究; 冠心病; 中医; 同证候系疾病

Key words: Master Protocol; Clinical research; Coronary heart disease; Traditional Chinese Medicine; Diseases with same syndrome pattern series

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