摘要
《证候类中药新药临床研究技术指导原则》(简称《指导原则》)的颁布使证候类中药新药的研发有了规范性指导文件。但在证候类中药新药研发实践中,仍面临着一些棘手的问题,制约着该类药物的研发进程。本文从证候类中药新药特点、研发面临的问题、真实世界研究实践出发,探讨基于真实世界开展证候类中药新药研究的可行性、相应的解决措施及研究设计等,将真实世界研究与证候类中药新药研究相融合,运用真实世界研究从中医药临床数据中挖掘有价值的信息,提出基于真实世界数据开展证候类中药新药的设计思路,为证候类药的研究提供参考。
The promulgation of Technical Guidelines for the Clinical Research of Syndrome-type TCM New Drugs(referred to as the Guiding Principles)has resulted in standardized guidance documents for the development of syndrome-type traditional Chinese drugs,which treat the diseases according to TCM theory of differentiation of syndromes.However,there are still some difficult problems in the research and development of new syndrome-type traditional Chinese drugs,which may restrict the development process of these drugs.From the following aspects:the characteristics of new syndrome-type traditional Chinese drugs,the problems in the research and development of these drugs,and the real-world researches on them,this paper explored the feasibility of researches,the solutions to difficulties and research design,etc.,in the research and development of new syndrome-type traditional Chinese drugs based on the real world,and provided the design ideas for the research of new syndrome-type traditional Chinese drugs based on real-world data.
作者
陈秋平
邵明义
赵瑞霞
毕倩
崔鸿雁
吕兰青
Chen Qiuping;Shao Mingyi;Zhao Ruixia;Bi Qian;Cui Hongyan;lv Lanqing(Henan University of Chinese Medicine,Zhengzhou 450000;First affiliated Hospital,Henan University of Chinese Medicine,Zhengzhou 450000;Henan traditional Chinese Medicine evidence-based Medicine Center,Zhengzhou 450000)
出处
《中药药理与临床》
CAS
CSCD
北大核心
2021年第6期171-174,共4页
Pharmacology and Clinics of Chinese Materia Medica
基金
河南省科技厅项目(编号:202102310169)
河南省特色骨干学科中医学学科建设项目(编号:STG-ZYXKY-2020011)
关键词
证候类中药新药
真实世界研究
真实世界数据
研究模式
New syndrome-type traditional Chinese drugs
Real world research
Real world data
Research model
作者简介
通信作者:邵明义,主任医师,博士研究生导师,主要研究方向:中医药临床疗效评价及消化系统疾病临床研究,E-mail:shmy1016@163.Com;陈秋平,硕士在读,主要研究方向:中西医结合防治消化疾病研究,E-mail:2065586237@qq.com。
