索磷布韦维帕他韦治疗儿童及青少年慢性丙型肝炎患者的疗效和安全性

肝脏 ›› 2026, Vol. 31 ›› Issue (6): 804-807.

索磷布韦维帕他韦治疗儿童及青少年慢性丙型肝炎患者的疗效和安全性

陈铭, 孙洁雨

210003 南京南京市第二医院药学部(陈铭);
210029 南京南京医科大学第一附属医院药学部(孙洁雨)

收稿日期:2025-06-06 出版日期:2026-06-30 发布日期:2026-07-29
通讯作者: 孙洁雨,Email:sunjieyu0706@njmu.edu.cn
基金资助:
南京市卫生科技发展专项资金项目计划(YKK22240)

The efficacy and safety of sofosbuvir/velpatasvir in the treatment of children and adolescent patients with chronic hepatitis C

Chen Ming¹, Sun Jieyu²

1. Department of Pharmacy, Nanjing Second Hospital, Nanjing 210003, China;
2. Department of Pharmacy, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China

Received:2025-06-06 Online:2026-06-30 Published:2026-07-29
Contact: Sun Jieyu,Email:sunjieyu0706@njmu.edu.cn

摘要/Abstract

摘要： 目的分析索磷布韦维帕他韦治疗儿童及青少年慢性丙型肝炎(CHC)患者的疗效和安全性。方法本研究为回顾性分析,纳入2022年3月至2024年1月期间于我院电子病历系统筛选的153例儿童及青少年CHC患者,依据治疗方法差异建立观察组(n=78)与对照组(n=75)。对比两组疗效、肝生化指标及肝纤维化指标变化及不良反应发生情况。结果观察组停药后24周持续病毒学应答(SVR24)(100.00% vs. 82.67%)、治疗结束时病毒学应答(EOT),(100.00% vs. 84%)、治疗4周早期病毒学应答(EVR)(92.31% vs. 81.33%)高于对照组(P<0.05)。治疗后,两组肝生化指标均降低,观察组下降趋势更明显[AST(26.10±2.29)U/L vs. (35.02±3.36)U/L;总胆红素(10.09±1.75)μmol/L vs. (13.20±2.23)μmol/L;ALT(25.04±2.40)U/L vs. (34.21±3.32)U/L ](均P<0.05)。治疗后,两组Ⅲ型前胶原N端肽(PC-Ⅲ)[(35.01±3.25)ng/mL vs. (42.38±4.46)ng/mL]、透明质酸酶(HA)[(84.11±9.13)ng/mL vs. (95.26±11.08)ng/mL]、层黏蛋白(LN)[(44.02±4.19)ng/mL vs. (53.65±7.83)ng/mL]水平均降低,以观察组更低(P<0.05)。两组不良反应总发生率(14.10% vs. 10.67%)对比差异无统计学意义(χ²=0.415,P=0.519)。结论索磷布韦维帕他韦治疗儿童及青少年CHC患者疗效确切,可改善患者肝功能,延缓肝纤维化进程,且安全性良好。

关键词: 索磷布韦, 维帕他韦, 儿童, 青少年, 慢性丙型肝炎, 疗效, 安全性

Abstract: Objective To analyze the efficacy and safety of sofosbuvir/velpatasvir in the treatment of children and adolescent patients with chronic hepatitis C (CHC). Methods A retrospective analysis was conducted on the medical records of 153 children and adolescents with CHC admitted to the hospital from March 2022 to January 2024. They were divided into an observation group (n=78) and a control group (n=75) according to different treatment methods. The efficacy, changes in liver function and liver fibrosis indexes and occurrence of adverse reactions in the two groups were compared. Results The sustained virological response at 24 weeks (SVR24)(100.00% vs. 82.67%), end of treatment response (EOT)(100.00% vs. 84%) and early virological response rate (EVR)(92.31% vs. 81.33%) at the end of treatment were higher in the observation group than those in the control group (P<0.05). After treatment, the levels of liver function index[AST(26.10±2.29)U/L vs. (35.02±3.36)U/L; total bilirubin (10.09±1.75)μmol/L vs. (13.20±2.23)μmol/L;ALT(25.04±2.40)U/L vs. (34.21±3.32) U/L] in both groups were decreased (P<0.05), and the downward trend of the observation group is more obvious. (P<0.05). After intervention, the serum concentrations of type III procollagen N-terminal peptide (PC-Ⅲ)[(35.01±3.25) ng/mL vs. (42.38±4.46) ng/mL], hyaluronidase acid (HA)[(84.11±9.13) ng/mL vs. (95.26±11.08) ng/mL] and laminin (LN)[(44.02±4.19) ng/mL vs. (53.65±7.83) ng/mL] demonstrated significant declines in both cohorts, with the observation group showing greater suppression in the biomarkers′ levels (P<0.05). There was no difference in the total incidence of adverse reactions between the two groups (14.10% vs. 10.67%) (χ²=0.415,P=0.519). Conclusion Sofosbuvir/velpatasvir is effective in the treatment of CHC in children and adolescents. It can improve the liver function and alleviate the progression of liver fibrosis, and is safe and reliable.

Key words: Sofosbuvir, Velpatasvir, Children, Teenagers, Chronic hepatitis C, Curative effect, Security

陈铭, 孙洁雨. 索磷布韦维帕他韦治疗儿童及青少年慢性丙型肝炎患者的疗效和安全性[J]. 肝脏, 2026, 31(6): 804-807.

Chen Ming, Sun Jieyu. The efficacy and safety of sofosbuvir/velpatasvir in the treatment of children and adolescent patients with chronic hepatitis C[J]. Chinese Hepatolgy, 2026, 31(6): 804-807.

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