Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University Medical Center, Palo Alto, California.
Clin Gastroenterol Hepatol. 2023 Apr;21(4):1013-1022.e6. doi: 10.1016/j.cgh.2022.05.015. Epub 2022 May 30.
BACKGROUND & AIMS: Serum-based noninvasive tests (NITs) have been widely used to assess liver fibrosis in patients with nonalcoholic fatty liver disease (NAFLD). However, the diagnostic efficacy of NITs across ranges of age, body mass index (BMI), and presence of type 2 diabetes (T2DM) may vary and have not been well-characterized.
We analyzed 1489 patients with biopsy-proven NAFLD from 6 centers in Japan, Taiwan, and Korea. Using histology as the gold standard, we compared the areas under the receiver operating characteristic (AUROCs) of Fibrosis-4 index (FIB-4), NAFLD fibrosis score (NFS), and the new Hepamet fibrosis score (HFS), with a focus on performance in subgroups as stratified by age, BMI, and the presence of T2DM.
By histology, 44.0% of the overall cohort (655/1489) had F2-4, and 20.6% (307/1489) had F3-4 fibrosis. FIB-4 had the highest AUROCs for both F2-4 (0.701 vs NFS 0.676 and HFS 0.682, P = .001) and F3-4 (0.767 vs NFS 0.736 and HFS 0.752, P = .002). However, for F3-4 fibrosis, the AUROCs of all 3 NITs were generally higher in older (>60 years), nonobese (BMI <25 kg/m), and non-diabetic patients, although overall the best performance was observed with FIB-4 among nonobese (BMI<25) diabetic patients (AUROC, 0.92). The worst performance was observed in younger patients with T2DM for all NITs including FIB-4 (AUROC, 0.63-0.66).
FIB-4 had higher diagnostic efficacy for F3-4 than NFS or HFS, but this varied greatly by age, BMI, and T2DM, with better performance in older, nonobese, and nondiabetic patients. However, all NITs including FIB-4 had unacceptably poor performance in young or obese diabetic patients.
血清无创检测（NITs）已广泛用于评估非酒精性脂肪性肝病（NAFLD）患者的肝纤维化程度。然而，NITs 在不同年龄、体重指数（BMI）和 2 型糖尿病（T2DM）患者中的诊断效能可能存在差异，且尚未得到充分研究。
我们分析了来自日本、中国台湾和韩国 6 家中心的 1489 例经肝活检证实的 NAFLD 患者。以组织学为金标准，我们比较了纤维化 4 指数（FIB-4）、NAFLD 纤维化评分（NFS）和新的 Hepamet 纤维化评分（HFS）的受试者工作特征曲线下面积（AUROCs），重点关注按年龄、BMI 和 T2DM 分层的亚组中的表现。
根据组织学，总体队列中 44.0%（655/1489）存在 F2-4 纤维化，20.6%（307/1489）存在 F3-4 纤维化。FIB-4 在 F2-4（0.701 比 NFS 0.676 和 HFS 0.682，P =.001）和 F3-4（0.767 比 NFS 0.736 和 HFS 0.752，P =.002）的诊断效能最高。然而，对于 F3-4 纤维化，所有 3 种 NIT 的 AUROCs 在年龄较大（>60 岁）、非肥胖（BMI <25 kg/m2）和非糖尿病患者中通常更高，尽管在非肥胖（BMI<25）糖尿病患者中，FIB-4 的整体表现最佳（AUROC，0.92）。在所有 NIT 中，年轻的 T2DM 患者的表现最差（AUROC，0.63-0.66）。
FIB-4 在诊断 F3-4 纤维化方面的诊断效能高于 NFS 或 HFS，但这在很大程度上取决于年龄、BMI 和 T2DM，在年龄较大、非肥胖和非糖尿病患者中表现更好。然而，所有 NIT，包括 FIB-4，在年轻或肥胖的糖尿病患者中表现不佳。
