Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China.
Fudan Institute for Metabolic Disease, Fudan University, Shanghai, China.
Diabetes Metab Res Rev. 2022 Nov;38(8):e3570. doi: 10.1002/dmrr.3570. Epub 2022 Aug 17.
The study aimed to develop a novel noninvasive model to detect advanced fibrosis based on routinely available clinical and laboratory tests.
A total of 309 patients who underwent liver biopsy were randomly divided into the estimation group (n = 201) and validation group (n = 108). The model was developed using multiple regression analysis in the estimation group and further verified in the validation group. Diagnostic accuracy was evaluated using the receiver operating characteristic (ROC) curve.
The model was named NAFLD Fibrosis Index (NFI): -10.844 + 0.046 × age - 0.01 × platelet count + 0.19 × 2h postprandial plasma glucose (PG) + 0.294 × conjugated bilirubin - 0.015 × ALT + 0.039 × AST + 0.109 × total iron binding capacity -0.033 × parathyroid hormone (PTH). The area under the ROC curve (AUC) of NFI was 0.86 (95% CI: 0.79-0.93, p < 0.001) in the estimation group and 0.80 (95% CI: 0.69-0.91, p < 0.001) in the validation group, higher than NFS, FIB4, APRI, and BARD, and similar to FibroScan (NFI AUC = 0.77, 95% CI: 0.66-0.89, p = 0.001 vs. FibroScan AUC = 0.76, 95% CI: 0.62-0.90, p = 0.002). By applying the low cut-off value (-2.756), advanced fibrosis could be excluded among 49.3% and 48% of patients in the estimation group (sensitivity: 93.1%, NPV: 97.9%, specificity: 55.2%, and PPV: 26.0%) and validation group (sensitivity: 81.3%, NPV: 94.2%, specificity: 53.3%, and PPV: 23.2%), respectively, allowing them to avoid liver biopsy.
The study has established a novel model for advanced fibrosis, the diagnostic accuracy of which is superior to the current clinical scoring systems and is similar to FibroScan.
本研究旨在开发一种新的无创模型，基于常规的临床和实验室检查来检测肝纤维化的进展。
共纳入 309 例接受肝活检的患者，将其随机分为评估组（n=201）和验证组（n=108）。在评估组中采用多元回归分析建立模型，并在验证组中进一步验证。采用受试者工作特征（ROC）曲线评估诊断准确性。
该模型命名为非酒精性脂肪性肝病纤维化指数（NFI）：-10.844+0.046×年龄-0.01×血小板计数+0.19×餐后 2 小时血糖（PG）+0.294×结合胆红素-0.015×丙氨酸氨基转移酶（ALT）+0.039×天冬氨酸氨基转移酶（AST）+0.109×总铁结合力-0.033×甲状旁腺激素（PTH）。在评估组中，NFI 的 ROC 曲线下面积（AUC）为 0.86（95%CI：0.79-0.93，p<0.001），在验证组中为 0.80（95%CI：0.69-0.91，p<0.001），高于 NFS、FIB4、APRI 和 BARD，与 FibroScan 相当（NFI AUC=0.77，95%CI：0.66-0.89，p=0.001 与 FibroScan AUC=0.76，95%CI：0.62-0.90，p=0.002）。通过应用低值截断值（-2.756），在评估组中，49.3%和 48%的患者可以排除晚期纤维化（敏感性：93.1%，阴性预测值：97.9%，特异性：55.2%，阳性预测值：26.0%）和验证组（敏感性：81.3%，阴性预测值：94.2%，特异性：53.3%，阳性预测值：23.2%），从而避免肝活检。
本研究建立了一种新的晚期纤维化模型，其诊断准确性优于目前的临床评分系统，与 FibroScan 相似。
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