在一个大型非酒精性脂肪性肝病真实世界队列中验证一种基于临床风险的分类系统。
Validation of a Clinical Risk-based Classification System in a Large Nonalcoholic Fatty Liver Disease Real-world Cohort.
机构信息
Virginia Commonwealth University, Department of Internal Medicine, Division of Gastroenterology, Hepatology and Nutrition, Richmond, VA.
Target RWE, Durham, NC.
出版信息
Clin Gastroenterol Hepatol. 2023 Oct;21(11):2889-2900.e10. doi: 10.1016/j.cgh.2023.02.024. Epub 2023 Mar 5.
BACKGROUND & AIMS: There is an unmet need to validate simple and easily available methods that can be used in routine practice to identify those at risk of adverse outcomes from nonalcoholic fatty liver disease (NAFLD). A retrospective-prospective analysis of NAFLD patients enrolled in a longitudinal noninterventional study (TARGET-NASH) was performed to validate the prognostic utility of the following risk-categories: (A) Fibrosis-4 (FIB-4) <1.3 and/or liver-stiffness measurement (LSM) measured by Fibroscan <8 kp, (B) FIB-4 1.31‒2.6 and/or LSM 8.1-12.5 kp, and (C) FIB-4 >2.6 and/or LSM >12.5 kp.
METHODS
Those in class A with aspartate transaminase:alanine transaminase ratio >1 or platelets <150,000/mm, or class B with aspartate transaminase:alanine transaminase ratio >1 or platelets <150,000/mm were upstaged by one class. Fine-Gray competing risk analyses were performed for all outcomes.
RESULTS
A total of 2523 individuals (class A = 555, B = 879, C = 1089) were followed for a median duration of 3.74 years. Adverse outcomes increased from class A to C in all-cause mortality (0.07 vs 0.3 vs 2.5/100 person-years [PY], hazard ratio [HR], 3.0 and 16.3 class B and C vs A), liver-associated clinical events (0.2 vs 1 vs 8/100 PY, HR, 4.3 and 36.6 B and C vs A), major adverse cardiovascular events (0.69 vs 0.87 vs 2.02/100 PY, HR, 0.78 and 1.55 B and C vs A), hepatocellular carcinoma (0 vs 0.09 vs 0.88/100 PY, HR, 8.32 C vs B), and chronic kidney disease (1.24 vs 2.48 vs 3.51/100 PY). Those who were upstaged had outcome rates similar to the lower class defined by their FIB-4.
CONCLUSIONS
These data support a FIB-4-based risk-stratification of NAFLD that can be used in routine clinical practice.
CLINICALTRIALS
gov Identifier: NCT02815891.
背景与目的
目前仍需要验证一些简单且易于获得的方法，以便在日常实践中识别出患有非酒精性脂肪性肝病（NAFLD）且有不良预后风险的患者。本研究对纳入一项非干预性纵向研究（TARGET-NASH）的 NAFLD 患者进行了回顾性前瞻性分析，以验证以下风险类别在预测预后方面的效用：（A）Fibrosis-4（FIB-4）<1.3 且/或肝脏硬度测量值（LSM）通过 Fibroscan 测量<8 kPa，（B）FIB-4 为 1.31-2.6 且/或 LSM 为 8.1-12.5 kPa，和（C）FIB-4>2.6 且/或 LSM>12.5 kPa。
方法
A 组中天门冬氨酸氨基转移酶：丙氨酸氨基转移酶比值>1 或血小板<150,000/mm³，或 B 组中天门冬氨酸氨基转移酶：丙氨酸氨基转移酶比值>1 或血小板<150,000/mm³的患者升一级。采用 Fine-Gray 竞争风险分析对所有结局进行分析。
结果
共纳入 2523 名患者（A 组 555 名，B 组 879 名，C 组 1089 名），中位随访时间为 3.74 年。全因死亡率从 A 级到 C 级逐渐升高（0.07 比 0.3 比 2.5/100 人年[PY]，风险比[HR]，B 和 C 级比 A 级分别为 3.0 和 16.3），与肝脏相关的临床事件（0.2 比 1 比 8/100 PY，HR，B 和 C 级比 A 级分别为 4.3 和 36.6），主要不良心血管事件（0.69 比 0.87 比 2.02/100 PY，HR，B 和 C 级比 A 级分别为 0.78 和 1.55），肝细胞癌（0 比 0.09 比 0.88/100 PY，HR，C 级比 B 级为 8.32）和慢性肾脏病（1.24 比 2.48 比 3.51/100 PY，HR，B 和 C 级比 A 级分别为 2.48 和 3.51）。升一级的患者结局发生率与他们的 FIB-4 定义的较低级别相似。
结论
这些数据支持基于 FIB-4 的 NAFLD 风险分层，可用于日常临床实践。
临床试验
gov 注册号：NCT02815891。
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