本次会议中,如何评价已有慢性肝病患者参加临床药物试验时DILI的发生引起了与会者极大的兴趣,现概括如下。一、如何评估慢性肝病患者的临床药物试验?针对新药上市前临床试验过程中可能出现的DILI,美国食品与药物管理局(FDA)已提供了一整套行之有效的评估框架和操作指南,以避免潜在的中毒性肝损伤的发生。但仍需从以下方面更新:(1)必须具备专业的临床医生和系统的实验室 In this meeting, how to evaluate the occurrence of DILI in patients with chronic liver disease who participated in the clinical drug test aroused great interest of the participants and is summarized as follows. How to Assess Clinical Drugs in Patients with Chronic Liver Diseases? The U.S. Food and Drug Administration (FDA) has provided a comprehensive set of proven assessment frameworks and operating guidelines for DILI that may emerge during premarket clinical trials Avoid potential toxic liver damage. But still need to be updated from the following aspects: (1) must have a professional clinician and system lab