中药临床研究的传承与创新  

Inheritance and innovation of clinical research of traditional Chinese medicine

作　　者：凌霄 王盼盼 马静[1] 孟菲[1,2] 李学林 LING Xiao;WANG Pan-pan;MA Jing;MENG Fei;LI Xue-lin(Henan Province Engineering Laboratory for Clinical Evaluation Technology of Chinese Medicine,Pharmaceutical Department,The First Affiliated Hospital of Henan University of CM,Zhengzhou 450003,China;Co-construction Collaborative Innovation Center for Traditional Chinese Medicine Prevention and Treatment of Respiratory Diseases by Henan and Education Ministry of China,Zhengzhou 450001,China;School of Pharmacy,Henan University of Chinese Medicine,Zhengzhou 450046,China)

机构地区：[1]河南中医药大学第一附属医院药学部,中药临床评价技术河南省工程实验室,郑州450003 [2]呼吸疾病中医药防治省部共建协同创新中心,郑州450001 [3]河南中医药大学药学院,郑州450046

出　　处：《中华中医药杂志》2021年第4期1801-1804,共4页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家重点研发计划(No.2017YFC1703400);中国博士后65批面上项目(No.2019M652549)。

摘　　要：目前的中药临床研究方法,无法充分凸显中药临床优势和特点,导致中医药普遍缺乏高水平临床循证依据,也阻碍了中药新药的研发。文章对中药临床研究进行横向和纵向比较,通过梳理中药临床研究的古今差异,中西差异,药学和医学临床研究的差异,分析传统与现代中药临床研究的不足,总结中药临床研究应具备的特点和内容,并以此为基础,对中药Ⅰ、Ⅱ、Ⅲ期临床试验的创新要点进行凝练,对中药传统临床研究方法的传承与创新提出建议,为中药临床研究方法体系的构建提供思路。Current clinical research methods of traditional Chinese medicine cannot fully highlight the clinical advantages and characteristics of traditional Chinese medicine,leading to the general lack of high-level clinical evidence-based basis of traditional Chinese medicine,and also hindering the research and development of new traditional Chinese medicine.A horizontal and vertical comparison on clinical research of traditional Chinese medicine,analyzes the shortcomings of clinical research of modern traditional Chinese medicine,summarizes the characteristics and contents of clinical research of traditional Chinese medicine was made in this paper,and on the basis of combing the ancient and modern differences in clinical research of traditional Chinese medicine,the differences between Chinese and Western medicine,the differences between pharmaceutical and clinical research of medicine,and summarizes the innovative points of clinical trials of traditional Chinese medicine in phases I,II and III suggestions are put forward for the inheritance and innovation of traditional Chinese medicine clinical research methods,which provide ideas for the construction of Chinese medicine clinical research method system.

关 键 词：中药 临床研究 传统临床研究方法 临床试验 

分 类 号：R24[医药卫生—中医临床基础]