摘要
近年来,为推进精准医学创新药物的发展,美国食品药品监督管理局推出了“篮子试验”和“雨伞试验”;开始批准依照生物标志物而不是肿瘤来源区分的抗肿瘤药物和适应症;并开始在药物临床评价中引用“真实世界证据”。显然,现代医学摒弃了以基于疾病分类的“随机对照试验”为金标准的理念,开始建构适应个性化医学的临床评价体系。中医辨证论治具备了个性化医学的全部特征,完全适用于这个临床评价体系。基于科学规范对辨证体系的标准化,将大数据技术用于临床的“真实世界”,并根据个性化原则进行疗效评价,将形成适合中医学的科学而经济的临床评价体系。
In recent years,in order to promote the development of innovative medicines for precision medicine,the US Food and Drug Administration(FDA)launched"basket trials"and"umbrella trials".It approved anti-tumor drugs and indications that do not differentiate by tumor source but by biomarkers;and cited evidences from"real-world studies"in clinical evaluations.This means that modern medicine has abandoned the traditional concept of"randomized controlled trials based on disease classification"as the gold standard and has begun to establish a clinical evaluation system that is compatible with personalized medicine.The treatment system based on syndrome differentiation of Traditional Chinese Medicine(TCM),has all the characteristics of personalized medicine,so its clinical evaluation is fully applicable to this evaluation system.On the basis of standardization of TCM syndrome differentiation system according to scientific principles,the application of big data analysis technology to the"real world"of TCM clinical practice,and efficacy evaluation based on the principles of personalized medicine,will constitute a scientific and economical clinical evaluation system suitable for TCM.
作者
袁冰
YUAN Bing(Hong Kong Modern Chinese Medicine R&D Center, Hong Kong 999077, China)
出处
《医学与哲学》
2020年第10期56-63,共8页
Medicine and Philosophy
关键词
临床试验
个性化医学
精准医学
疗效评价
真实世界
中医学
clinical trial
personalized medicine
precision medicine
efficacy evaluation
real world
Traditional Chinese Medicine
作者简介
袁冰(1959-),男,研究员,研究方向:中医发展战略、中医现代化、中西医结合方法论,E-mail:greenisland@vip.163.com。
