Medicine (Baltimore). 2017 Mar;96(12):e6336. doi: 10.1097/MD.0000000000006336.
Evaluation of APRI and FIB-4 for noninvasive assessment of significant fibrosis and cirrhosis in HBeAg-negative CHB patients with ALT ≤ 2 ULN: A retrospective cohort study.
Li Q1, Ren X, Lu C, Li W, Huang Y, Chen L.
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1 Department of Hepatitis, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
Abstract
To evaluate the performance of aspartate transaminase-to-platelet ratio index (APRI) and fibrosis index based on four factors (FIB-4) to predict significant fibrosis and cirrhosis in hepatitis B virus e antigen (HBeAg)-negative chronic hepatitis B (CHB) patients with alanine transaminase (ALT) ≤ twice the upper limit of normal (2 ULN).Histologic and laboratory data of 236 HBeAg-negative CHB patients with ALT ≤ 2 ULN were analyzed. Predicted fibrosis stage, based on established scales and cut-offs for APRI and FIB-4, was compared with METAVIR scores obtained from liver biopsy.In this study, the areas under the receiver operating characteristic curves (AUROCs) of APRI were lower than that of FIB-4 (0.62 vs 0.69; P = 0.019) for diagnosing significant fibrosis; however APRI and FIB-4 were comparable for diagnosing cirrhosis (0.77 vs 0.81; P = 0.374). When the cut-off proposed by WHO HBV guideline for APRI (>2.0) was used, no cirrhotic patients were correctly predicted. For FIB-4, the WHO proposed cut-off of 3.25 correctly identified significant fibrosis 83% of the time; but for APRI, the WHO proposed cut-off of 1.5 identified significant fibrosis 56%. In ruling out significant fibrosis, the WHO proposed APRI cut-off of 0.5 had a predictive value of 39%, and the FIB-4 cut-off of 1.45 correctly identified lack of significant fibrosis in 47% of the patients. In this study, based on ROC analysis, the optimal cut-offs were 0.46 and 0.65 for APRI, and 1.05 and 1.29 for FIB-4, for diagnosing significant fibrosis and cirrhosis, respectively. When the new cut-off of APRI (>0.65) was used, 82% of the cirrhotic patients were correctly predicted. In ruling out significant fibrosis, the new APRI cut-off (<0.46) had a predictive value of 80%, and new FIB-4 cut-off (<1.05) correctly identified lack of significant fibrosis in 84% of the patients.The WHO guidelines proposed cut-offs might be higher for HBeAg-negative CHB patients with ALT ≤2 ULN, and might underestimate the proportion of significant fibrosis and cirrhosis. A new set of cut-offs should be used to predict significant fibrosis and cirrhosis in this specific population.
基于四个因素(FIB-4)评估天冬氨酸转氨酶 - 血小板比指数(APRI)和纤维化指数的表现,以预测乙型肝炎病毒e抗原(HBeAg)阴性慢性乙型肝炎(CHB)中明显的纤维化和肝硬化)丙氨酸转氨酶(ALT)患者≤正常上限的两倍(2 ULN)。对236例ALT≤2ULN的HBeAg阴性CHB患者的组织学和实验室资料进行了分析。将基于APRI和FIB-4的成熟规模和临界值的预测纤维化阶段与从肝活检获得的METAVIR评分进行比较。在本研究中,APRI受试者工作特征曲线(AUROC)下的面积低于的FIB-4(0.62 vs 0.69; P = 0.019)用于诊断显着的纤维化;然而APRI和FIB-4可诊断肝硬化(0.77 vs 0.81; P = 0.374)。世卫组织提出的针对APRI的HBV指南(> 2.0)提出的切断点,没有正确预测肝硬化患者。对于FIB-4,世卫组织提出了截止3.25正确鉴定83%的显着纤维化的时间;但是对于APRI,世卫组织提出的临界值为1.5,确定明显的纤维化56%。在排除显着的纤维化方面,世卫组织提出的APRI临界值为0.5,预测值为39%,FIB-4临界值为1.45,正确确定了47%的患者缺乏明显的纤维化。在本研究中,基于ROC分析,APRI的最佳临界值分别为0.46和0.65,FIB-4分别为1.05和1.29,用于诊断纤维化和肝硬化。当使用APRI(> 0.65)的新截止时,82%的肝硬化患者被正确预测。在排除显着的纤维化方面,新APRI临界值(<0.46)具有80%的预测值,新发的FIB-4临界值(<1.05)正确地确定了84%的患者缺乏明显的纤维化。 HBeAg阴性CHB患者ALT≤2ULN的世界卫生组织准则提案可能会更高,并可能低估明显的纤维化和肝硬化的比例。应该使用一组新的临界点预测这一特定人群中明显的纤维化和肝硬化。