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  

Master protocol applied to the prevention and treatment of Traditional Chinese Medicine for coronary heart disease: ideas and methods of evidence-based optimization

作　　者：胡嘉元 张晓雨[1] 赵晨 孙杨 陈诗琪[1] 李承羽 刘硕[1] 邱瑞瑾[1] 田贵华[1] 商洪才[1] HU Jiayuan;ZHANG Xiaoyu;ZHAO Chen;SUN Yang;CHEN Shiqi;LI Chengyu;LIU Shuo;QIU Ruijin;TIAN Guihua;SHANG Hongcai(Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Beijing,100700,P.R.China;School of Chinese Medicine,Hong Kong Baptist University,Hong Kong,999077,P.R.China)

机构地区：[1]北京中医药大学东直门医院,北京100700 [2]香港浸会大学中医药学院,中国香港999077

出　　处：《中国循证医学杂志》2019年第1期102-106,共5页Chinese Journal of Evidence-based Medicine

基　　金：国家重点研发计划项目(编号:2017YFC1700402);国家自然科学基金项目(编号:81725024)

摘　　要：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,成为一种临床资源使用少和医学信息获得多的高效率临床试验新模式,其已在临床肿瘤研究中得到一定应用。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,为同证候系疾病的中医临床研究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 highly efficient new model of clinical trials which could obtain 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 on 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 on diseases with similary 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 

分 类 号：R259[医药卫生—中西医结合]