NAFLD/NASH新药研发关键因素分析

Analysis of key factors affecting on the drug development for NAFLD/NASH

非酒精性脂肪性肝病(nonalcoholic fatty liver disease,NAFLD)是最常见的慢性肝病之一,现已成为全球性健康问题,但目前仍没有针对该疾病的药物上市。本文讨论了专家共识中对疾病的最新定义,归纳了造成疾病异质性的多个因素,讨论了该疾病临床前动物模型的研究进展,对模型的类型、特征和应用进行分析,同时针对临床试验方案设计中的关键点,探讨如何提高新药开发的成功率。

Nonalcoholic fatty liver disease(NAFLD)is one of the most common chronic liver diseases.It has become a global health problem.However,there is still no drug for the disease.This article discusses the latest definition of disease in the expert consensus and summarizes the multiple factors that contribute to disease heterogeneity.This research discusses the progress of preclinical animal models of the disease,and further analyzes the types,characteristics and applications of the models.At the same time,based on the key points in the design of clinical trial protocols,how to improve the success rate of new drug development is discussed.