药物性肝损伤（drug-induced liver injury，DILI）是急性肝衰竭和药物退出市场的主要原因。大量研究已经从药物的理化性质、体内代谢和作用机制等方面对DILI进行深入研究，为药物研发提供了充分的生物信息。即便如此，DILI尤其是中药诱导肝损伤事件依旧时有发生。机体与药物的相互影响和作用是DILI发生的主要因素。因此，从临床患者和实验动物等角度入手，系统整理和分析不同影响因素，如生活习惯、生理病理状态，年龄、遗传差异、性别等对DILI的影响，评价其与DILI之间的关系，以期为未来中药系统安全性评价技术和方法的完善、中药安全使用提供参考。

Drug-induced liver injury (DILI) is a major cause of acute liver failure and drug withdrawal from the market. Numerous studies have been conducted to investigate DILI in depth in terms of the physicochemical properties, in vivo metabolism and mechanism of action of drugs, providing sufficient biological information for drug development. Even so, incidents of DILI, especially herbal-induced liver injury, continue to occur. The interaction and effect of organism and drug is the main factor in the occurrence of DILI. Therefore, the effects of different influencing factors, such as lifestyle habits, physiopathological status, age, genetic differences, gender, etc. on DILI from the perspectives of clinical patients and experimental animals were systematically collected and analyzed in this paper, and the relationship between them and DILI was evaluated, in order to provide a reference for the improvement of systematic safety evaluation techniques and methods of traditional Chinese medicine and the safe use of traditional Chinese medicine in the future.

R285.53

国家科技重大专项（2018ZX09735005）；公益性行业科研专项（2015070042）；北京中医药大学新教师启动基金资助项目（2020-JYB-XJSJJ-009）