CIOMS《药物性肝损伤国际共识》解读——草药和膳食补充剂(HDS)致肝损伤  

Interpretation on Consensus on drug-induced liver injury by CIOMS Working Group:liver injury attributed to herbal and dietary supplements

作　　者：景婧 王睿林 柏兆方 郭玉明 何婷婷 王伽伯 宋海波 肖小河 JING Jing;WANG Rui-lin;BAI Zhao-fang;GUO Yu-ming;HE Ting-ting;WANG Jia-bo;SONG Hai-bo;XIAO Xiao-he(Fifth Medical Center of Chinese PLA General Hospital,Beijing 100039,China;School of Traditional Chinese Medicine,Capital Medical University,Beijing 100069,China;Center for Drug Reevaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]解放军总医院第五医学中心,北京100039 [2]首都医科大学中医药学院,北京100069 [3]国家药品监督管理局药品评价中心,北京100022

出　　处：《中国中药杂志》2023年第9期2552-2556,共5页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(82104702,81874368,81930110,81673806);国家中医药管理局中医药传承与创新(岐黄学者)项目([2018]288);国家中医药管理局中医药创新团队及人才支持计划项目(ZYYCXTD-C-202005);中国医药教育协会2020重大科学攻关问题和医药技术难题项目(2020KTY001)。

摘　　要：随着医疗水平的提高、药品不良反应监测体系的完善及民众安全用药意识的增强,药物安全性事件被频繁报道,药物性肝损伤(DILI)尤其是草药和膳食补充剂(HDS)相关肝损伤受到国内外的高度关注,给临床用药和药品安全监管带来日益严峻的挑战。国际医学科学组织理事会(CIOMS)DILI工作组于2020年发布了《药物性肝损伤国际共识》,首次将HDS致肝损伤列为专章,围绕HDS致肝损伤的定义、流行病学史、潜在风险因素、相关风险信号收集、因果关系评价以及风险防控与管理等热点问题,从全球视角展开论述。基于前期工作,中国专家受CIOMS邀请,编制该章节的同时,首创基于整合证据链(iEC)法的药源性肝损伤因果关系评价得到国内外专家的广泛认可,并被写入该共识。该文简要介绍了《药物性肝损伤国际共识》的主要内容、制定背景及其特点,同时在此基础上重点对第8章HDS致肝损伤及其要点、亮点予以解读分析,供国内中西医医务人员和科研人员参考。With the increase in the medical level,the improvement of adverse drug reaction(ADR)monitoring systems,and the enhancement of public awareness of safe medication,drug safety incidents have been frequently reported.Drug-induced liver injury(DILI),especially liver injury attributed to herbal and dietary supplements(HDS),has globally attracted high attention,bringing great threats and severe challenges to the people for drug safety management such as clinical medication and medical supervision.Consensus on drug-induced liver injury had been published by the Council for International Organizations of Medical Sciences(CIOMS)in 2020.In this consensus,liver injury attributed to HDS was included in a special chapter for the first time.The hot topics,including the definition of HDS-induced liver injury,epidemiological history,potential risk factors,collection of related risk signals,causality assessment,risk prevention,control and management were discussed from a global perspective.Based on the previous works,some experts from China were invited by CIOMS to undertake the compilation of this chapter.Meanwhile,a new causality assessment in DILI based on the integrated evidence chain(iEC)method was widely recognized by experts in China and abroad,and was recommended by this consensus.This paper briefly introduced the main contents,background,and characteristics of the Consensus on drug-induced liver injury.Significantly,a brief interpretation was illustrated to analyze the special highlights of Chapter 8,"Liver injury attributed to HDS",so as to provide practical references for the medical staff and the researchers who worked on either Chinese or Western medicine in China.

关 键 词：药物性肝损伤 草药和膳食补充剂 因果关系评价 整合证据链 风险防控 

分 类 号：R575[医药卫生—消化系统]