纤维最大值和炎症标志物不能替代肝活检用于评估非酒精性脂肪性肝病。
Fibromax and inflamatory markers cannot replace liver biopsy in the evaluation of non-alcoholic fatty liver disease.
机构信息
Graduate Program in Medicine, Department of Hepatology, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.
Graduate Program in Medicine, Department of Hepatology, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil -
出版信息
Minerva Gastroenterol (Torino). 2022 Mar;68(1):85-90. doi: 10.23736/S2724-5985.20.02746-4. Epub 2020 Jul 22.
BACKGROUND
To evaluate the performance of a non-invasive test (Fibromax™, Ferring Pharmaceutical, Saint-Prex, Switzerland) and inflamatory markers (IL-1β, IL-6, IL-8, TNF-α, MCP-1) in the diagnosis and staging of patients with non-alcoholic fatty liver disease.
METHODS
Patients older than 18 years with steatosis were prospectively evaluated at a tertiary hospital in southern Brazil. Liver biopsy, Fibromax™ test and inflamatory markers (IL-1β, IL-6, IL-8, TNF-α, MCP-1) were performed. Measures of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were used, considering liver biopsy as the gold standard.
RESULTS
Seventy-three Fibromax™ tests were analyzed. SteatoTest presented a sensitivity of 95.5% and PPV of 97.0% for the diagnosis of steatosis. NashTest obtained a sensitivity of 83.3%, specificity of 37.5%, PPV of 90.9% and NPV of 23.1% for the diagnosis of non-alcoholic steatohepatitis (NASH). FibroTest presented a sensitivity of 38.9%, specificity of 92.7%, PPV of 63.6% and NPV of 82.3% to evaluate advanced fibrosis. In the evaluation of patients with grade 2 and 3 steatosis, ROC analyses showed an area under the curve (AUROC) for SteatoTest of 0.68 (P=0.015). NashTest AUROC was 0.59 (P=0.417) for the evaluation of NASH. FibroTest AUROC was 0.79 (P<0.001) for advanced fibrosis. Kappa coefficient values for SteatoTest, NashTest and FibroTest were not statistically significant. Thirty-seven patients performed also analysis of the inflamatory markers, showing that patients with inflammatory activity grade 2-3 on liver biopsy had significantly higher levels of IL6 (P=0.016) and lower TNF-α (P=0.034), but there was no other difference when analysed fibrosis or steatosis.
CONCLUSIONS
The Fibromax™ test and the inflamatory markers (IL-1β, IL-6, IL-8, TNF-α, MCP-1) did not present a satisfactory performance to be considered a good alternative to replace liver biopsy in the evaluation of non-alcoholic fatty liver disease.
背景
评估一种非侵入性检测（Fibromax™，辉凌制药，圣普雷克斯，瑞士）和炎症标志物（IL-1β、IL-6、IL-8、TNF-α、MCP-1）在诊断和分期非酒精性脂肪性肝病患者中的性能。
方法
在巴西南部的一家三级医院，前瞻性评估年龄大于 18 岁的脂肪变性患者。进行肝活检、Fibromax™检测和炎症标志物（IL-1β、IL-6、IL-8、TNF-α、MCP-1）。考虑肝活检为金标准，使用敏感性、特异性、阳性预测值（PPV）、阴性预测值（NPV）和准确性来评估。
结果
分析了 73 次 Fibromax™测试。SteatoTest 对脂肪变性的诊断具有 95.5%的敏感性和 97.0%的阳性预测值。NashTest 对非酒精性脂肪性肝炎（NASH）的诊断具有 83.3%的敏感性、37.5%的特异性、90.9%的 PPV 和 23.1%的 NPV。FibroTest 对评估晚期纤维化具有 38.9%的敏感性、92.7%的特异性、63.6%的 PPV 和 82.3%的 NPV。在评估 2 级和 3 级脂肪变性的患者时，SteatoTest 的 ROC 分析曲线下面积（AUROC）为 0.68（P=0.015）。NashTest 的 AUROC 为 0.59（P=0.417），用于评估 NASH。FibroTest 的 AUROC 为 0.79（P<0.001），用于评估晚期纤维化。SteatoTest、NashTest 和 FibroTest 的 Kappa 系数值没有统计学意义。37 名患者还进行了炎症标志物的分析，结果显示，肝活检有 2-3 级炎症活动的患者 IL6 水平显著升高（P=0.016），TNF-α水平显著降低（P=0.034），但在分析纤维化或脂肪变性时没有其他差异。
结论
Fibromax™检测和炎症标志物（IL-1β、IL-6、IL-8、TNF-α、MCP-1）的性能不佳，不能替代肝活检来评估非酒精性脂肪性肝病。
Zotero 插件