《中药新药用于慢性胃炎的临床疗效评价技术指导原则(试行)》内容解读  

Details and interpretations of clinical research guidance of new drug of Chinese medicine in chronic gastritis

作　　者：卞立群[1] 王凤云[1] 陈婷[1] 王萍[1] 唐旭东[1] BIAN Liqun;WANG Fengyun;CHEN Ting;WANG Ping;TANG Xudong(Institute of Spleen Stomach Disease,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing,100091,China)

机构地区：[1]中国中医科学院西苑医院脾胃病研究所,北京100091

出　　处：《中国中西医结合消化杂志》2024年第11期961-965,共5页Chinese Journal of Integrated Traditional and Western Medicine on Digestion

基　　金：中国中医科学院科技创新工程(No:CI2021A01006,No:CI2021B005);国家中医药传承创新团队项目(No:ZYYCXTD-202010);第七批全国老中医药专家学术经验继承项目。

摘　　要：慢性胃炎是消化系统常见病之一,关于其新药研发是重要的临床关注点。《中药新药用于慢性胃炎的临床疗效评价技术指导原则(试行)》由国家药品监督管理局于2022年12月发布,本文对该指导原则中的内容进行解读(不含“胃黏膜萎缩、肠化生、上皮内瘤变”部分),为科研提供参考。Chronic gastritis is one of the commonest diseases in digestive system;the research and development of new drugs for chronic gastritis are more and more focused in clinical practice.Clinical research guidance of new drug of Chinese medicine in chronic gastritis was published in December 2022 by National Medical Products Administration.Details and interpretations in this clinical research guidance were specially described in this article in order to provide references for clinical researches.

关 键 词：中药新药 慢性胃炎 指导原则 临床疗效评价 

分 类 号：R256.3[医药卫生—中医内科学]