Busuyi Sogo Jide, Ajose Abiodun Olabamiji, Ojo Olusegun Sylvester, Adekanle Olusegun, Smith Olufemi Samuel, Ajala Adetokunbo Oluwafunso, Betiku Omolade Adefolabi
Department of Chemical Pathology, Obafemi Awolowo University Teaching Hospital Complex, Ile-Ife, Nigeria.
Department of Morbid Anatomy and Forensic Medicine, Obafemi Awolowo University Teaching Hospital Complex, Ile-Ife, Nigeria.
Niger Med J. 2025 Apr 3;66(1):156-164. doi: 10.71480/nmj.v66i1.653. eCollection 2025 Jan-Feb.
Hepatitis B virus (HBV) is a major cause of chronic liver disease worldwide. Fibrosis of hepatic parenchyma has been reported as a common pathway to complications of chronic liver disease. There is a need to monitor fibrosis in these patients to abort or delay disease progression following treatment. Liver biopsy is recognized as the gold standard for disease monitoring; however, the procedure is invasive and bedeviled with potential complications. For these reasons, non-invasive biomarkers of fibrosis are now being evaluated as alternatives to liver biopsy. The study aimed to assess the characteristics of laminin, and hyaluronic acid as markers of hepatic fibrosis in patients with chronic hepatitis B.
One hundred participants with HBV-induced chronic liver disease (CLD) were recruited for the study. A liver biopsy was conducted, and the degree of hepatic fibrosis was scored using the Metavir scoring system. Serum levels of the biomarkers were determined using enzyme-linked immunosorbent assay (ELISA) technique. Medians and interquartile ranges were compared using the Mann-Whitney U test. The degree of correlation between continuous variables was determined using Spearman's correlation analysis. Statistical significance was set at p ≤ 0.05.
Serum laminin was significantly higher in participants with hepatic fibrosis: 39.09 (27.6-89.4) ng/ml [median (interquartile range)], vs 24.3 (21.5-31.9) ng/ml, p = 0.001, Hyaluronic acid was significantly higher in participants with hepatic fibrosis: 45.1 (26.9-94.4) ng/ml vs 23.1 (12.7-35.7) ng/ml, p < 0.001. There was a strong significant positive correlation of both serum laminin and hyaluronic acid with Metavir score in the study participants (r=0.766, p<0.001; r=0.708, p<0.001 respectively). At a serum laminin concentration of 44.6 ng/ml, sensitivity and specificity for detecting moderate to severe hepatic fibrosis were 86.8% and 88.7% respectively, with an area under the curve (AUC) of 0.943 on the Receiver Operator Characteristic (ROC) curve. The sensitivity and specificity of hyaluronic acid for detecting moderate to severe hepatic fibrosis were 81.6% and 85.5% at a serum concentration of 53.5 ng/ml. AUC was 0.930 on the ROC curve.
This study underscores the evidence that laminin and hyaluronic acid may be helpful clinically in identifying patients with moderate to severe hepatic fibrosis. Serum laminin had a slightly better diagnostic ability than hyaluronic acid in the study participants. Further studies are needed to elucidate our findings.
乙型肝炎病毒（HBV）是全球慢性肝病的主要病因。肝实质纤维化已被报道为慢性肝病并发症的常见途径。有必要对这些患者的纤维化进行监测，以便在治疗后中止或延缓疾病进展。肝活检被认为是疾病监测的金标准；然而，该操作具有侵入性且存在潜在并发症。由于这些原因，目前正在评估纤维化的非侵入性生物标志物作为肝活检的替代方法。本研究旨在评估层粘连蛋白和透明质酸作为慢性乙型肝炎患者肝纤维化标志物的特征。
招募了100名HBV引起的慢性肝病（CLD）患者参与本研究。进行了肝活检，并使用梅塔维评分系统对肝纤维化程度进行评分。使用酶联免疫吸附测定（ELISA）技术测定生物标志物的血清水平。使用曼-惠特尼U检验比较中位数和四分位间距。使用斯皮尔曼相关分析确定连续变量之间的相关程度。统计学显著性设定为p≤0.05。
肝纤维化患者的血清层粘连蛋白显著更高：39.09（27.6 - 89.4）ng/ml[中位数（四分位间距）]，而无肝纤维化患者为24.3（21.5 - 31.9）ng/ml，p = 0.001。肝纤维化患者的透明质酸显著更高：45.1（26.9 - 94.4）ng/ml，而无肝纤维化患者为23.1（12.7 - 35.7）ng/ml，p < 0.001。在研究参与者中，血清层粘连蛋白和透明质酸与梅塔维评分均呈强显著正相关（分别为r = 0.766，p < 0.001；r = 0.708，p < 0.001）。当血清层粘连蛋白浓度为44.6 ng/ml时，检测中度至重度肝纤维化的敏感性和特异性分别为86.8%和88.7%，受试者工作特征（ROC）曲线下面积（AUC）为0.943。当血清透明质酸浓度为53.5 ng/ml时，检测中度至重度肝纤维化的敏感性和特异性分别为81.6%和85.5%。ROC曲线上的AUC为0.930。
本研究强调了层粘连蛋白和透明质酸在临床上可能有助于识别中度至重度肝纤维化患者的证据。在研究参与者中，血清层粘连蛋白的诊断能力略优于透明质酸。需要进一步的研究来阐明我们的发现。
