El-Haggar Sahar M, Attalla Dina S, Elhelbawy Mostafa, El-Afify Dalia R
Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, El-Gharbia Government, Tanta, Egypt.
Faculty of Pharmacy, Menoufia University, Shebin El-kom, Egypt.
Inflammopharmacology. 2025 Jan;33(1):329-339. doi: 10.1007/s10787-024-01628-3. Epub 2025 Jan 9.
This study aimed to assess the potential antifibrotic impact of zinc sulfate in chronic Hepatitis C Virus (HCV) patients receiving direct-acting antiviral therapy.
This randomized controlled study included 50 chronic HCV-infected patients with fibrosis stage (F1 & F2). Participants were randomly assigned to two groups: Group 1 (Control group, n = 25) received standard direct-acting antiviral therapy for 3 months, while Group 2 (Zinc group, n = 25) received 50 mg/day of zinc sulfate in addition to the standard direct-acting antiviral therapy for the same duration. Baseline and 3-month post-intervention assessments included evaluating serum levels of hyaluronic acid, transforming growth factor beta-1, and fibronectin. Furthermore, indices of liver fibrosis, such as the Fibrosis Index based on the 4 factors (FIB-4) and the Aspartate Transaminase-to-Platelet-Ratio Index (APRI), were calculated during these assessments.
At baseline, the two studied groups had no statistical difference in demographic and laboratory data. After treatment, serum zinc levels significantly increased in the zinc-treated group compared to the control group. Additionally, serum fibronectin and hyaluronic acid levels were significantly reduced in group 2 (zinc group) compared to group 1 (control group). Moreover, zinc group showed lower APRI scores than the control group after a 3-month follow-up period, but there was non-significant difference in FIB-4 scores between the two groups after treatment. Furthermore, total bilirubin levels were reduced after zinc therapy for 3 months.
Administering zinc sulfate could potentially serve as a safe and efficient therapeutic strategy for the management of hepatic fibrosis in individuals with chronic hepatitis C virus.
ClinicalTrials.gov identifier: NCT05465434, On 19/7/2022.
本研究旨在评估硫酸锌对接受直接抗病毒治疗的慢性丙型肝炎病毒（HCV）患者的潜在抗纤维化作用。
本随机对照研究纳入了50例纤维化分期为F1和F2的慢性HCV感染患者。参与者被随机分为两组：第1组（对照组，n = 25）接受标准直接抗病毒治疗3个月，而第2组（锌组，n = 25）除接受相同疗程的标准直接抗病毒治疗外，还每日服用50毫克硫酸锌。基线和干预后3个月的评估包括评估血清透明质酸、转化生长因子β-1和纤连蛋白水平。此外，在这些评估期间计算肝纤维化指标，如基于4项因素的纤维化指数（FIB-4）和天冬氨酸转氨酶与血小板比值指数（APRI）。
基线时，两个研究组在人口统计学和实验室数据方面无统计学差异。治疗后，锌治疗组的血清锌水平与对照组相比显著升高。此外，与第1组（对照组）相比，第2组（锌组）的血清纤连蛋白和透明质酸水平显著降低。此外，随访3个月后，锌组的APRI评分低于对照组，但治疗后两组的FIB-4评分无显著差异。此外，锌治疗3个月后总胆红素水平降低。
对于慢性丙型肝炎病毒感染者，硫酸锌给药可能是一种安全有效的肝纤维化治疗策略。
ClinicalTrials.gov标识符：NCT05465434，于2022年7月19日注册。
