Nonalcoholic Fatty Liver Disease Adult Database 2

Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions that can progress to significant fibrosis and cirrhosis. There are an estimated 40-90 million individuals within the United States with NAFLD, 10- 30% of whom have NASH and may develop NASH-related cirrhosis. Identifying through non- invasive means those individuals who are at risk for progressive liver disease remains challenging.

The Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) was initiated by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002 to conduct multicenter, collaborative studies on the etiology, contributing factors, natural history, complications and treatment of NASH.

The NAFLD Adult Database 2 continued the longitudinal follow-up of participants enrolled in earlier NASH CRN studies and recruited new participants with recent liver biopsies. Comprehensive data, including demographics, medical history, symptoms, medication use, alcohol use and routine laboratory studies were collected on all participants at entry and at annual visits for up to 10 years after enrollment. A liver biopsy was collected at baseline if not collected in a prior NASH CRN study. Study questionnaires administered at enrollment included Skinner Lifetime Drinking history, Alcohol Use Disorders Identification Test (AUDIT) and Beverage Questionnaire (BEVQ-15).

Specimens were collected every 48 weeks during follow-up. If liver biopsies were obtained as part of routine patient care, they were scored using the NASH CRN NAFLD Activity Score (NAS) and fibrosis score. The Interim drinking history (AUDIT-C) and BEVQ-15 were collected at follow-up visits.

非酒精性脂肪性肝病（Nonalcoholic fatty liver disease, NAFLD）是一类可进展为显著纤维化及肝硬化的肝脏病症谱系。据估算，美国现有4000万至9000万成年人罹患非酒精性脂肪性肝病，其中10%至30%会进展为非酒精性脂肪性肝炎（Nonalcoholic Steatohepatitis, NASH），并可能发展为NASH相关性肝硬化。通过无创手段识别进展性肝病高风险人群仍是当前的一大挑战。

非酒精性脂肪性肝炎临床研究网络（Nonalcoholic Steatohepatitis Clinical Research Network, NASH CRN）由美国国立糖尿病、消化和肾脏疾病研究所（National Institute of Diabetes and Digestive and Kidney Diseases, NIDDK）于2002年发起，旨在开展多中心合作研究，探索NASH的病因学、致病因素、自然病程、并发症及治疗方案。

非酒精性脂肪性肝病成人数据库2（NAFLD Adult Database 2）延续了此前NASH CRN研究入组受试者的纵向随访工作，并新招募了近期接受过肝活检的受试者。研究在入组时及入组后最长10年内的年度随访中，收集所有受试者的人口统计学资料、病史、症状、用药情况、饮酒史及常规实验室检查等多维度数据。若受试者此前未参与过NASH CRN研究，则需在基线时采集肝活检样本。入组时填写的研究问卷包括：斯金纳终生饮酒史问卷、饮酒障碍识别测试（Alcohol Use Disorders Identification Test, AUDIT）及饮料摄入问卷（Beverage Questionnaire, BEVQ-15）。

随访期间每48周采集一次样本。若受试者在常规诊疗过程中获取了肝活检样本，则采用NASH CRN制定的非酒精性脂肪性肝病活动评分（NASH CRN NAFLD Activity Score, NAS）及纤维化评分进行评估。随访就诊时还需填写临时饮酒史问卷（AUDIT-C）及BEVQ-15问卷。