Sezione di Gastroenterologia, DiBiMIS, University of Palermo, Palermo, Italy.
Liver Int. 2015 May;35(5):1566-73. doi: 10.1111/liv.12584. Epub 2014 May 20.
BACKGROUND & AIMS: The accuracy of noninvasive tools for the diagnosis of severe fibrosis in patients with nonalcoholic fatty liver disease(NAFLD) in clinical practice is still limited. We aimed at assessing the diagnostic performance of combined noninvasive tools in two independent cohorts of Italian NAFLD patients.
We analysed data from 321 Italian patients(179 Sicilian-training cohort, and 142 northern Italy-validation cohort) with an histological diagnosis of NAFLD. Severe fibrosis was defined as fibrosis ≥ F3 according to Kleiner classification. The APRI, AST/ALT, BARD, FIB-4, and NFS scores were calculated according to published algorithms. Liver stiffness measurement(LSM) was performed by FibroScan. Cut-off points of LSM, NFS and FIB-4 for rule-in or rule-out F3-F4 fibrosis were calculated by the reported formulas.
In the Sicilian cohort AUCs of LSM, NFS, FIB-4, LSM plus NFS, LSM plus FIB-4, and NFS plus FIB-4 were 0.857, 0.803, 0.790, 0.878, 0.888 and 0.807, respectively, while in the northern Italy cohort the corresponding AUCs were 0.848, 0.730, 0.703, 0.844, 0.850, and 0.733 respectively. In the training cohort, the combination of LSM plus NFS was the best performing strategy, providing false positive, false negative and uncertainty area rates of 0%,1.1% and 48% respectively. Similar results were obtained in the validation cohort with false positive, false negative and uncertainty area rates of 0%,7.3% and 40.8%.
The combination of LSM with NFS, two complementary, easy-to-perform, and widely available tools, is able to accurately diagnose or exclude the presence of severe liver fibrosis, also reducing of about 50-60% the number of needed diagnostic liver biopsies.
在临床实践中，非侵入性工具诊断非酒精性脂肪性肝病（NAFLD）患者严重纤维化的准确性仍然有限。我们旨在评估联合非侵入性工具在两个意大利 NAFLD 患者独立队列中的诊断性能。
我们分析了 321 名意大利患者（179 名西西里培训队列和 142 名意大利北部验证队列）的组织学诊断为 NAFLD 的数据。严重纤维化定义为根据 Kleiner 分类纤维化≥F3。根据已发表的算法计算 APRI、AST/ALT、BARD、FIB-4 和 NFS 评分。通过 FibroScan 进行肝硬度测量（LSM）。通过报告的公式计算 LSM、NFS 和 FIB-4 的截断值，用于规则内或规则外 F3-F4 纤维化。
在西西里队列中，LSM、NFS、FIB-4、LSM 加 NFS、LSM 加 FIB-4 和 NFS 加 FIB-4 的 AUC 分别为 0.857、0.803、0.790、0.878、0.888 和 0.807，而在意大利北部队列中的 AUC 分别为 0.848、0.730、0.703、0.844、0.850 和 0.733。在培训队列中，LSM 加 NFS 的组合是表现最好的策略，假阳性、假阴性和不确定性区域的发生率分别为 0%、1.1%和 48%。在验证队列中也得到了类似的结果，假阳性、假阴性和不确定性区域的发生率分别为 0%、7.3%和 40.8%。
LSM 与 NFS 的结合，两种互补、易于实施且广泛可用的工具，能够准确诊断或排除严重肝纤维化的存在，同时减少约 50-60%的所需诊断性肝活检数量。
