药物性肝损伤研究概述

Drug-induced liver injury: a brief overview

药物性肝损伤(DILI)是造成药物研发失败、药物限制使用甚至撤出市场的主要原因之一,也是引发肝病的重要原因之一。然而,由于DILI症状的多样化和诊断金标准的缺乏,临床上很难将其确诊,也没有针对DILI的有效治疗方案,只能靠停药和对症支持治疗来缓解。应对DILI的最佳措施是在病发早期识别危害,以便能做到危害评价和危害回避,因此,开发新的DILI生物标志物是一条有效的应对途径,虽然目前并没有确定出新的标准,但有一些潜在的生物标志物已经得到认可。本文就DILI的危险因素、引发方式、临床分类、诊断和处理及生物标志物做一简要综述。

Drug-induced liver injury （DILI） has become an increasingly important entity and a major cause for failures of drug development programs, drug withdrawals from market and use restrictions. Unfortunately, varied clinical manifestations, and lack of a gold diagnostic criterion have made DILI very difficult to manage or cure. By far, available treatment of DILI consists of rapid drug dis- continuation and supportive care targeted to alleviate unwanted symptoms. To prevent the progression to liver disease and acute liver failure, early hazard identification, risk assessment and avoidance strategies are essential for scientists to address the gaps in hepatic biomarkers faced during drug development. Although there are no breakthroughs, several novel biomarker candidates have been identi- fied. A brief overview is made on the risk management, pathogenesis, clinical classification, diagnosis, treatment and biomarker of DILI.