中国药物警戒 ›› 2026, Vol. 23 ›› Issue (1): 115-119.
DOI: 10.19803/j.1672-8629.20250483

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慢性乙型肝炎抗病毒治疗安全性研究进展

王媛慧1, 张清1, 李歆2#, 苏钰文1,2,*   

  1. 1南京医科大学附属逸夫医院临床药理研究中心,江苏 南京 211100;
    2南京医科大学药学院,江苏 南京 211166
  • 收稿日期:2025-09-13 出版日期:2026-01-15 发布日期:2026-01-15
  • 通讯作者: *苏钰文,男,博士,副教授,临床药理学。E-mail: suyuwen@njmu.edu.cn; #为共同通信作者。
  • 作者简介:王媛慧,女,硕士,主治医师,临床医学。
  • 基金资助:
    国家自然科学基金资助项目（72574107、72074123）; 江苏省卫生健康委医学科研项目（M2022076）; 中国毒理学会临床毒理专项项目（CST2020CT111）

Research Progress in Safety of Antiviral Therapy for Chronic Hepatitis B

WANG Yuanhui1, ZHANG Qing1, LI Xin2#, SU Yuwen1,2,*   

  1. 1Department of Clinical Pharmacology, Sir Run Run Hospital, Nanjing Medical University, Nanjing Jiangsu 211100, China;
    2School of Pharmacy, Nanjing Medical University, Nanjing Jiangsu 211166, China
  • Received:2025-09-13 Online:2026-01-15 Published:2026-01-15

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摘要： 目的 通过对慢性乙型肝炎抗病毒治疗药物的临床安全性分析,为此类适应证的临床合理用药与药物研发提供参考。方法 基于PubMed、中国知网和万方数据库2020年1月至2025年6月的相关文献,对已上市品种和临床研发阶段相关药物的研究进展进行分析,并对其单独用药和联合用药的安全性进行探讨。结果 已上市的核苷（酸）类似物在安全性方面表现尚可,但长期使用时需对肾毒性、骨代谢影响、妊娠不良事件,以及血脂异常等方面保持警惕;干扰素治疗需要额外关注对血液系统、神经精神和自身免疫性疾病的影响。对于临床研发过程中的试验用药物,需特别关注肝功能异常、免疫相关不良反应、注射部位的不良反应等。结论 核苷（酸）类似物在抑制病毒复制、改善肝脏组织学、降低肝细胞癌的发生率方面获益显著,虽然不良事件涉及多个系统,但整体发生率较低且严重程度较轻。鉴于其长期使用的特性,仍需持续关注其安全性问题。干扰素治疗应在有资质的医生的指导下进行,并密切监测不良反应。未来药物研发聚焦于靶向病毒生命周期关键环节或宿主免疫调控,为疾病完全治愈提供更多安全且高效的选择。

关键词: 慢性乙型肝炎, 抗病毒药物, 核苷（酸）类似物, 干扰素, 药品不良反应

Abstract: Objective To summarize the research progress in the clinical safety of antiviral drugs used for chronic hepatitis B and to provide references to related clinical applications and drug development. Methods Based on literature available in PubMed, the China National Knowledge Infrastructure (CNKI), and Wanfang Data over the past five years (between January 2020 and June 2025), this study traced the research progress in marketed drugs as well as agents under clinical development. The safety profiles of both monotherapies and combination therapies were assessed. Results Marketed nucleoside analogues proved to be relatively safe, but long-term use called for vigilance on potential nephrotoxicity, disturbances in bone metabolism, adverse pregnancy outcomes, and dyslipidemia. During interferon therapy, special attention needed to be paid to its potential impacts on the hematopoietic system, neuropsychiatric function, and autoimmune disorders. For investigational drugs under clinical development, hepatic dysfunction, immune-related adverse events, and injection-site reactions were worthy of attention. Conclusion Nucleoside analogues can play a pivotal role in suppressing viral replication, improving liver histology, and reducing the incidence of hepatocellular carcinoma. Despite the multiple systems in adverse events, the overall incidence is low and symptoms are mild. For long-term users, safety is a big concern. Interferon treatment should proceed under the supervision of qualified physicians, with constant monitoring of adverse reactions. Future development of novel pharmaceuticals is to revolve around key stages in the viral life cycle or modulation of host immunity in order to offer safer and more effective options for a complete cure.

Key words: Chronic Hepatitis B, Antiviral Drugs, Nucleoside Analogues, Interferon, Adverse Drug Reactions

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