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.
Zhongguo Zhong Yao Za Zhi. 2023 May;48(9):2552-2556. doi: 10.19540/j.cnki.cjcmm.20230123.501.
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.
随着医学水平的提高、药品不良反应(ADR)监测系统的完善以及公众安全用药意识的增强,药品安全事件屡有报道。药物性肝损伤(DILI),尤其是由草药和膳食补充剂(HDS)引起的肝损伤,在全球范围内备受关注,给临床用药和医疗监管等药品安全管理工作带来了巨大威胁和严峻挑战。国际医学科学组织理事会(CIOMS)于2020年发布了关于药物性肝损伤的共识。在这份共识中,由HDS引起的肝损伤首次被纳入一个专门章节。从全球角度讨论了包括HDS所致肝损伤的定义、流行病学史、潜在危险因素、相关风险信号的收集、因果关系评估、风险预防、控制和管理等热点话题。基于以往的工作,CIOMS邀请了一些中国专家参与该章节的编撰。同时,一种基于整合证据链(iEC)方法的DILI新因果关系评估方法在国内外得到了专家的广泛认可,并被该共识所推荐。本文简要介绍了《药物性肝损伤共识》的主要内容、背景和特点。重要的是,对第8章“由HDS引起的肝损伤”的特别亮点进行了简要解读,以便为中国从事中西医工作的医务人员和研究人员提供实际参考。