Kang Yeo-Wool, Baek Yang-Hyun, Moon Sang-Yi
Department of Internal Medicine, Dong-A University College of Medicine, 32 Daeshingongwonro, Seo-gu, Busan 49021, Republic of Korea.
Diagnostics (Basel). 2024 Nov 11;14(22):2517. doi: 10.3390/diagnostics14222517.
: Multiple non-invasive tests (NITs) for identifying advanced fibrosis in patients with non-alcoholic fatty liver disease (NAFLD) are available, but, due to the limitations of single NITs, the American Association for the Study of Liver Disease (AASLD) guidelines suggest a two-step strategy, combining the Fibrosis-4 Index (FIB-4) score with the Enhanced Liver Fibrosis (ELF) test to improve diagnostic accuracy and minimize unnecessary liver biopsies. However, few real-world studies have used such a sequential approach. We here evaluated the diagnostic accuracy of the ELF test in patients with recently established metabolic dysfunction-associated steatotic liver disease (MASLD) and assessed the clinical utility of applying a two-step strategy, including the ELF test following the FIB-4 score assessment, in patients with MASLD. We enrolled 153 patients diagnosed with MASLD who underwent liver biopsy at the Dong-A University Hospital between June 2018 and August 2023. The degree of fibrosis was determined based on liver biopsy results. Various NITs were used, including the Aminotransferase-to-Platelet Ratio Index (APRI), FIB-4 score, NAFLD Fibrosis score (NFS) and ELF test. The diagnostic efficacy of these NITs was evaluated based on the area under the receiver operating characteristic curve (AUROC). Additionally, the performance of each test was further examined both when applied individually and in a two-step approach, where FIB-4 was used followed by ELF testing. Key metrics such as sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy were used for this analysis. Overall, 153 patients with MASLD (mean age: 46.62 years; 52.3% men; 28.1% with type 2 diabetes) were included. The performance of the NITs in identifying advanced fibrosis was as follows: the AUROC of the APRI, FIB-4, NFS, and ELF tests were 0.803 (95% confidence interval (CI), 0.713-0.863), 0.769 (95% CI, 0.694-0.833), 0.699 (95% CI, 0.528-0.796), and 0.829 (95% CI, 0.760-0.885), respectively. The combination of the FIB-4 score ≥ 1.30 and the ELF score ≥ 9.8 showed 67.86% sensitivity, 90.40% specificity, a PPV of 75.18%, an NPV of 86.78%, an accuracy of 83.64%, and an AUROC of 0.791 for predicting the diagnosis of advanced fibrosis. This approach excluded 28 patients (71.8%) from unnecessary liver biopsies. Our study demonstrated that ELF testing maintained diagnostic accuracy in assessing liver fibrosis in patients with MASLD in real-world practice. This test was used as a second step in the evaluation, reducing clinically unnecessary invasive liver biopsies and referrals to tertiary institutions. This approach allows assessment of MASLD severity in primary care settings without requiring additional equipment.
目前有多种用于识别非酒精性脂肪性肝病（NAFLD）患者中晚期纤维化的非侵入性检测（NITs），但由于单一NITs存在局限性，美国肝病研究协会（AASLD）指南建议采用两步策略，即将纤维化-4指数（FIB-4）评分与增强肝纤维化（ELF）检测相结合，以提高诊断准确性并尽量减少不必要的肝活检。然而，很少有真实世界研究采用这种序贯方法。我们在此评估了ELF检测在近期确诊的代谢功能障碍相关脂肪性肝病（MASLD）患者中的诊断准确性，并评估了在MASLD患者中应用包括在FIB-4评分评估后进行ELF检测的两步策略的临床实用性。我们纳入了2018年6月至2023年8月期间在东国大学医院接受肝活检的153例确诊为MASLD的患者。根据肝活检结果确定纤维化程度。使用了多种NITs，包括天冬氨酸转氨酶与血小板比值指数（APRI）、FIB-4评分、NAFLD纤维化评分（NFS）和ELF检测。基于受试者操作特征曲线下面积（AUROC）评估这些NITs的诊断效能。此外，分别单独应用以及采用FIB-4检测后再进行ELF检测的两步法对每项检测的性能进行了进一步检验。该分析使用了敏感性、特异性、阳性预测值（PPV）、阴性预测值（NPV）和准确性等关键指标。总体而言，纳入了153例MASLD患者（平均年龄：46.62岁；52.3%为男性；28.1%患有2型糖尿病）。NITs在识别晚期纤维化方面的表现如下：APRI、FIB-4、NFS和ELF检测的AUROC分别为0.803（95%置信区间（CI），0.713 - 0.863）、0.769（95%CI，0.694 - 0.833）、0.699（95%CI，0.528 - 0.796）和0.829（95%CI，0.760 - 0.885）。FIB-4评分≥1.30且ELF评分≥9.8的组合在预测晚期纤维化诊断时显示出67.86%的敏感性、90.40%的特异性、75.18%的PPV、86.78%的NPV、83.64%的准确性以及0.791的AUROC。这种方法使[此处可能有误，原文应为28例]28例患者（71.8%）免于不必要的肝活检。我们的研究表明，在真实世界实践中，ELF检测在评估MASLD患者肝纤维化时保持了诊断准确性。该检测作为评估的第二步，减少了临床上不必要的侵入性肝活检以及转至三级医疗机构的情况。这种方法无需额外设备即可在基层医疗环境中评估MASLD的严重程度。
