NAFLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California San Diego, La Jolla, CA, United States; Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
NAFLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California San Diego, La Jolla, CA, United States; Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.
J Hepatol. 2022 Dec;77(6):1482-1490. doi: 10.1016/j.jhep.2022.07.020. Epub 2022 Aug 13.
BACKGROUND & AIMS: Patients with non-alcoholic fatty liver disease (NAFLD) and significant fibrosis (fibrosis stage ≥2) are candidates for pharmacological trials. The aim of this study was to perform a head-to-head comparison of the diagnostic test characteristics of three non-invasive stiffness-based models including MEFIB (magnetic resonance elastography [MRE] plus FIB-4), MAST (magnetic resonance imaging [MRI]-aspartate aminotransferase [AST]), and FAST (FibroScan-AST) for detecting significant fibrosis.
This prospective study included 563 patients with biopsy-proven NAFLD undergoing contemporaneous MRE, MRI proton density fat fraction (MRI-PDFF) and FibroScan from two prospective cohorts derived from Southern California and Japan. Diagnostic performances of models were evaluated by area under the receiver-operating characteristic curve (AUC).
The mean age of the cohort was 56.5 years (51% were women). Significant fibrosis was observed in 51.2%. To detect significant fibrosis, MEFIB outperformed both MAST and FAST (both p <0.001); AUCs for MEFIB, MAST, and FAST were 0.901 (95% CI 0.875-0.928), 0.770 (95% CI 0.730-0.810), and 0.725 (95% CI 0.683-0.767), respectively. Using rule-in criteria, the positive predictive value of MEFIB (95.3%) was significantly higher than that of FAST (83.5%, p = 0.001) and numerically but not statistically greater than that of MAST (90.0%, p = 0.056). Notably, MEFIB's rule-in criteria covered more of the study population than MAST (34.1% vs. 26.6%; p = 0.006). Using rule-out criteria, the negative predictive value of MEFIB (90.1%) was significantly higher than that of either MAST (69.6%) or FAST (71.8%) (both p <0.001). Furthermore, to diagnose "at risk" non-alcoholic steatohepatitis defined as NAFLD activity score ≥4 and fibrosis stage ≥2, MEFIB outperformed both MAST and FAST (both p <0.05); AUCs for MEFIB, MAST, and FAST were 0.768 (95% CI 0.728-0.808), 0.719 (95% CI 0.671-0.766), and 0.687 (95% CI 0.640-0.733), respectively.
MEFIB was better than MAST and FAST for detection of significant fibrosis as well as "at risk" NASH. All three models provide utility for the risk stratification of NAFLD.
Non-alcoholic fatty liver disease (NAFLD) affects over 25% of the general population worldwide and is one of the main causes of chronic liver disease. Because so many individuals have NAFLD, it is not practical to perform liver biopsies to identify those with more severe disease who may require pharmacological interventions. Therefore, accurate non-invasive tests are crucial. Herein, we compared three such tests and found that a test called MEFIB was the best at detecting patients who might require treatment.
患有非酒精性脂肪性肝病（NAFLD）和显著纤维化（纤维化分期≥2）的患者是药物临床试验的候选者。本研究的目的是对头对头比较三种基于硬度的非侵入性模型的诊断试验特征，包括 MEFIB（磁共振弹性成像[MRE]加 FIB-4）、MAST（磁共振成像[MRI]-天冬氨酸氨基转移酶[AST]）和 FAST（FibroScan-AST），以检测显著纤维化。
这项前瞻性研究纳入了来自南加州和日本的两个前瞻性队列中 563 名经活检证实的 NAFLD 患者，同时进行 MRE、MRI 质子密度脂肪分数（MRI-PDFF）和 FibroScan。通过接受者操作特征曲线下面积（AUC）评估模型的诊断性能。
队列的平均年龄为 56.5 岁（51%为女性）。观察到 51.2%的患者存在显著纤维化。为了检测显著纤维化，MEFIB 优于 MAST 和 FAST（均 p<0.001）；MEFIB、MAST 和 FAST 的 AUC 分别为 0.901（95%CI 0.875-0.928）、0.770（95%CI 0.730-0.810）和 0.725（95%CI 0.683-0.767）。使用规则纳入标准，MEFIB（95.3%）的阳性预测值显著高于 FAST（83.5%，p=0.001），并且数值上高于但无统计学意义上高于 MAST（90.0%，p=0.056）。值得注意的是，MEFIB 的规则纳入标准涵盖了比 MAST 更多的研究人群（34.1% vs. 26.6%；p=0.006）。使用规则排除标准，MEFIB（90.1%）的阴性预测值显著高于 MAST（69.6%）或 FAST（71.8%）（均 p<0.001）。此外，为了诊断定义为 NAFLD 活动评分≥4 和纤维化分期≥2的“风险”非酒精性脂肪性肝炎，MEFIB 优于 MAST 和 FAST（均 p<0.05）；MEFIB、MAST 和 FAST 的 AUC 分别为 0.768（95%CI 0.728-0.808）、0.719（95%CI 0.671-0.766）和 0.687（95%CI 0.640-0.733）。
MEFIB 优于 MAST 和 FAST 用于检测显著纤维化和“风险”NASH。这三种模型均为 NAFLD 的风险分层提供了实用性。
非酒精性脂肪性肝病（NAFLD）影响着全球超过 25%的普通人群，是慢性肝病的主要原因之一。由于如此多的个体患有 NAFLD，对其进行肝脏活检以确定可能需要药物干预的更严重疾病患者并不实际。因此，准确的非侵入性检测至关重要。在此，我们比较了三种此类检测方法，发现一种名为 MEFIB 的检测方法在检测可能需要治疗的患者方面效果最好。
