Sezione di Gastroenterologia, PROMISE, University of Palermo, Italy.
Dipartimento di Biomedicina, Neuroscienze e Diagnostica avanzata (BIND), University of Palermo, Palermo, Italy.
Clin Gastroenterol Hepatol. 2023 May;21(5):1293-1302.e5. doi: 10.1016/j.cgh.2022.06.013. Epub 2022 Jul 14.
BACKGROUND & AIMS: We aimed to assess the diagnostic accuracy of AGILE 3+, a recently developed score based on the combination of aspartate aminotransferase/alanine aminotransferase ratio, platelet count, diabetes status, sex, age, and liver stiffness measurement (LSM) by transient elastography, when compared with Fibrosis-4 (FIB-4) and LSM, for the diagnosis of advanced fibrosis and for the prediction of liver-related events (LREs) occurrence in patients with NAFLD.
A total of 614 consecutive patients with biopsy-proven NAFLD or clinical diagnosis of NAFLD-related compensated cirrhosis were enrolled. LREs were recorded during follow-up. FIB-4, LSM by transient elastography (FibroScan device), and AGILE 3+ were measured. The diagnostic performance of noninvasive criteria for advanced fibrosis and for the prediction of LREs was assessed using the area under the receiver operating characteristic curve (AUROC) and decision curve analysis.
In patients with biopsy-proven NAFLD (n = 520), LSM and AGILE 3+ had higher AUROC than FIB-4 (0.88 for LSM and AGILE 3+ vs 0.78 for FIB-4; P < .001) for advanced fibrosis, and AGILE 3+ exhibited a smaller indeterminate area in the test (25.2% for FIB-4 vs 13.1% for LSM vs 8.3% for AGILE 3+). Within the entire cohort of patients, AGILE 3+ had significantly higher AUROC for predicting LREs with respect to LSM (AUROC 36 months 0.95 vs 0.93; P =.008; 60 months 0.95 vs 0.92; P = .006; 96 months 0.97 vs 0.95; P = .001). Decision curve analysis showed that all scores had modest net benefit for ruling-out advanced fibrosis at the risk threshold of 5% to 10% where advanced fibrosis was absent. At the risk threshold of 5% of false negatives or false positives in LRE at 36, 60, 96, and 120 months, AGILE 3+ outperformed both FIB-4 and LSM for ruling out LRE.
Depending on resource availability, clinical setting, and the risk scenarios, AGILE 3+ is an accurate and valid alternative to FIB-4 and LSM for the noninvasive assessment of disease severity and prognosis in patients with NAFLD.
我们旨在评估 AGILE 3+的诊断准确性,AGILE 3+是一种新开发的评分系统,基于天门冬氨酸氨基转移酶/丙氨酸氨基转移酶比值、血小板计数、糖尿病状态、性别、年龄和瞬时弹性成像测量的肝硬度(LSM)组合而成,与 Fibrosis-4(FIB-4)和 LSM 相比,用于诊断晚期纤维化,并预测非酒精性脂肪性肝病(NAFLD)患者的肝脏相关事件(LREs)发生。
共纳入 614 例经活检证实的 NAFLD 或临床诊断为 NAFLD 相关代偿性肝硬化患者。在随访期间记录 LREs。测量 FIB-4、瞬时弹性成像(FibroScan 设备)的 LSM 和 AGILE 3+。使用受试者工作特征曲线(AUROC)和决策曲线分析评估非侵入性标准诊断晚期纤维化和预测 LREs 的性能。
在经活检证实的 NAFLD 患者(n=520)中,LSM 和 AGILE 3+的 AUROC 高于 FIB-4(LSM 和 AGILE 3+的 AUROC 为 0.88,而 FIB-4 的 AUROC 为 0.78;P<0.001),用于诊断晚期纤维化,而 AGILE 3+在测试中具有更小的不确定区域(FIB-4 为 25.2%,LSM 为 13.1%,AGILE 3+为 8.3%)。在整个患者队列中,AGILE 3+在预测 LREs 方面与 LSM 相比具有更高的 AUROC(36 个月 AUROC 0.95 与 0.93;P=0.008;60 个月 AUROC 0.95 与 0.92;P=0.006;96 个月 AUROC 0.97 与 0.95;P=0.001)。决策曲线分析表明,所有评分在 5%至 10%的风险阈值下,在无晚期纤维化的情况下,对于排除晚期纤维化具有适度的净获益。在 36、60、96 和 120 个月时 LRE 的 5%假阴性或假阳性风险阈值下,AGILE 3+在排除 LRE 方面优于 FIB-4 和 LSM。
根据资源可用性、临床环境和风险情况,AGILE 3+是一种准确有效的替代 FIB-4 和 LSM 的方法,可用于评估 NAFLD 患者的疾病严重程度和预后。