慢性丙型肝炎患者中，非侵入性生物标志物FibroTest和ActiTest与肝活检的对比：中东地区的经验

Noninvasive biomarkers FibroTest and ActiTest versus liver biopsy in chronic hepatitis C patients: the Middle East experience.

作者信息

Yakoob Rafie, Bozom Issam Al, Thandassery Ragesh Babu, Rahman Mohamed Osman Abdel, Derbala Moutaz F, Mohannadi Muneera J Al, John Anil K, Sharma Manik, Wani Hamidulla, Kaabi Saad Al

机构信息

Division of Gastroenterology and Hepatology (Rafie Yakoob, Ragesh Babu Thandassery, Moutaz F. Derbala, Muneera J. Al Mohannadi, Anil K. John, Manik Sharma, Hamidulla Wani, Saad Al Kaabi), Hamad General Hospital, Doha, Qatar.

Department of Laboratory Medicine and Pathology (Issam Al Bozom), Hamad General Hospital, Doha, Qatar.

出版信息

Ann Gastroenterol. 2015 Apr-Jun;28(2):265-270.

PMID:25830472

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4367218/

Abstract

BACKGROUND

The aim of this study was to compare noninvasive biomarkers, FibroTest and ActiTest in predicting fibrosis stage and inflammation grade in chronic hepatitis C (CHC) patients with liver biopsy (LB).

METHODS

In 107 patients with CHC, levels of six serum biomarkers (alanine aminotransferase, γ-glutamyl transpeptidase, total bilirubin, haptoglobin, apolipoprotein, α-2 macroglobulin) were determined at the time of LB. LB was evaluated by Metavir score for fibrosis and inflammation. Voluntary blood donors (n=106) were taken as controls for the study.

RESULTS

Fibrosis estimated by Fibrotest was significantly higher in patients compared to control group. The observed area under the receiver operating characteristic curve (AUROC) for advanced fibrosis (F3, F4) adjusted according to the observed difference between advanced and non-advanced fibrosis prevalence (DANA) was 0.80 (0.69-0.88) and the AUROC for cirrhosis (F4) was 0.94 (0.86-0.98). ActiTest AUROC for moderate to severe activity (A2A3) was 0.72 (0.61-0.81), and for severe activity (A3) was 0.88 (0.78-0.93). The diagnostic values in the group of good quality biopsy (n=41) showed Fibrotest AUROC (DANA-adjusted): for advanced fibrosis 0.90 (0.72-0.99); for cirrhosis 0.93 (0.76-0.98); and ctiTest AUROC: for moderate/severe activity 0.86 (0.67-0.94); and for severe activity 0.90 (0.76-0.93). There was good concordance between FibroTest and LB (with discordance for two or more stages in <20% for advanced fibrosis and <10% for cirrhosis) and between ActiTest and LB. Specificity for FibroTest and ActiTest in the control population were 95% and 100% respectively.

CONCLUSIONS

Fibrotest and ActiTest had high observed and standardized diagnostic values for predicting fibrosis and activity respectively.

摘要

背景

本研究旨在比较非侵入性生物标志物FibroTest和ActiTest在通过肝活检（LB）预测慢性丙型肝炎（CHC）患者纤维化分期和炎症分级方面的作用。

方法

对107例CHC患者在进行肝活检时测定六种血清生物标志物（丙氨酸转氨酶、γ-谷氨酰转肽酶、总胆红素、触珠蛋白、载脂蛋白、α-2巨球蛋白）的水平。肝活检通过Metavir评分评估纤维化和炎症情况。选取106名自愿献血者作为研究对照。

结果

与对照组相比，Fibrotest评估的患者纤维化程度显著更高。根据晚期和非晚期纤维化患病率的观察差异（DANA）调整后的晚期纤维化（F3、F4）的受试者操作特征曲线下面积（AUROC）为0.80（0.69 - 0.88），肝硬化（F4）的AUROC为0.94（0.86 - 0.98）。ActiTest对中度至重度活动（A2A3）的AUROC为0.72（0.61 - 0.81），对重度活动（A3）的AUROC为0.88（0.78 - 0.93）。在高质量活检组（n = 41）中，诊断价值显示Fibrotest的AUROC（经DANA调整）：晚期纤维化为0.90（0.72 - 0.99）；肝硬化为0.93（0.76 - 0.98）；ActiTest的AUROC：中度/重度活动为0.86（0.67 - 0.94）；重度活动为0.90（0.76 - 0.93）。FibroTest与肝活检之间（晚期纤维化两个或更多分期的不一致率<20%，肝硬化<10%）以及ActiTest与肝活检之间具有良好的一致性。FibroTest和ActiTest在对照人群中的特异性分别为95%和100%。