肝组织学评估在非酒精性脂肪性肝病临床研究及实践中的作用

Role of histological evaluation of the liver in clinical practice and research on nonalcoholic fatty liver disease

肝活组织检查是非酒精性脂肪性肝病(NAFLD),尤其是非酒精性脂肪性肝炎(NASH)诊断的"金标准",尽管肝穿刺检查存在有创性、取样和评价误差等局限性,但在NAFLD/NASH临床试验研究及新药临床试验中,肝组织学评价是研究队列患者入组、主要治疗终点和(或)次要治疗终点评价的主要评价指标,具有其他方法目前尚不可替代的作用。NAFLD/NASH的组织学评价系统主要包括Brunt系统、美国NASH临床研究网络评分系统、欧洲SAF/FLIP评分系统和儿童NAFLD组织学评分系统,在临床实践和研究中应选择适合的组织学评分系统。

Liver biopsy is currently the gold standard for the diagnosis of nonalcoholic fatty liver disease（ NAFLD）,especially nonalcoholic steatohepatitis（ NASH）. Although liver biopsy has the limitations such as invasiveness,sampling error,and evaluation error,in clinical trials of NAFLD/NASH and related new drugs,it is still used to evaluate the enrollment of patients into a cohort and primary and/or secondary endpoints and cannot be replaced by other methods. The histological evaluation systems of NAFLD/NASH mainly include Brunt system,NASH-CRN scoring system,European SAF/FLIP scoring algorithm,and pediatric NAFLD histological scoring system,and an appropriate histological scoring system should be selected in clinical practice and research.