中医医疗机构在人用经验规范收集整理方面的探索实践与展望  

Exploratory practice and prospect of collecting and collating human experience in TCM medical institutions

作　　者：朱雪琦[1] 程金莲[1] 李博[1] 刘宝利[1] 刘清泉[1] ZHU Xue-qi;CHENG Jin-lian;LI Bo;LIU Bao-li;LIU Qing-quan(Bejing Hospital of Traditional Chinese Medicine,Bejing 100010,China)

机构地区：[1]首都医科大学附属北京中医医院,北京100010

出　　处：《中国新药杂志》2022年第16期1571-1573,共3页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目:创新药物全过程临床评价示范性技术平台建设(2019ZX09734001);北京中医医院院级课题暨两院合作项目:调肝安神颗粒治疗原发性失眠的成药性研究,基于风险评估的临床科研课题全过程质量控制工具的研究(LY201801,LY201807)。

摘　　要：人用经验作为支持中药注册审评证据体系的关键组成是对中医药学实践经验的重视,是尊重中医药学发展规律的体现。如何在中医医疗机构规范收集整理人用经验,并建立人用经验利用的可持续发展机制,是充分利用人用经验使之成为中医药学取之不尽动力源泉的保障。本文结合我院正在开展的国医大师临床经验方的新药研发经验,从学术经验及临床数据梳理收集、临床数据治理评估、整体规划临床及非临床研究等实施过程总结在这方面的实践探索。Human experience as the key component of evidence system supporting traditional Chinese medicine(TCM)registration evaluation is the emphasis on TCM practical experience and the embodiment of respecting the development law of TCM.How to collect and organize the human experience in TCM medical institutions and establish the sustainable development mechanism of the use of human experience is the guarantee to make full use of human experience and make it become the inexhaustible power source of TCM.Based on the new drug development experience of TCM master clinical experience in our hospital,this paper discussed the practical experience in this field from the implementation process of academic experience and clinical data collection,clinical data management evaluation,overall planning of clinical and non-clinical studies.

关 键 词：人用经验 中医医疗机构 中药注册审评 证据体系 

分 类 号：R95[医药卫生—药学]