中国药物警戒 ›› 2026, Vol. 23 ›› Issue (3): 355-360.
DOI: 10.19803/j.1672-8629.20250771

• 综述 • 上一篇    

辐射防治药物警戒研究

龙欢, 王凯鑫, 杨悦琦, 安明惠, 梁雨薇, 刘红冉, 高旭, 张丽, 丁佳欣, 宫建*   

  1. 沈阳药科大学药物流行病与临床药物评价课题组,辽宁 沈阳 110016
  • 收稿日期:2025-10-31 出版日期:2026-03-15 发布日期:2026-03-17
  • 通讯作者: *宫建,男,博士,教授,药物流行病学。E-mail: fanxing1230@163.com
  • 作者简介:龙欢,女,在读硕士,药物流行病学。
  • 基金资助:
    沈阳药科大学中青年教师事业发展支持计划立项（ZQN202205）

Pharmacovigilance for Radioprotective Drugs

LONG Huan, WANG Kaixin, YANG Yueqi, AN Minghui, LIANG Yuwei, LIU Hongran, GAO Xu, ZHANG Li, DING Jiaxin, GONG Jian*   

  1. Research Group of (Jian Gong) on Pharmacoepidemiology and Clinical Drug Evaluation, Shenyang Pharmaceutical University, Shenyang Liaoning 110016, China
  • Received:2025-10-31 Online:2026-03-15 Published:2026-03-17

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摘要： 目的 分析辐射防治药物在药物警戒中面临的挑战,并提出系统性优化策略,以促进临床安全合理用药。方法 通过文献调研,系统梳理辐射防治药物的分类及代表药物,归纳其在药物警戒中存在的关键问题,并基于问题提出相应的对策与建议。结果 辐射防治药物可分为辐射防护剂、辐射缓解剂与辐射治疗剂三类;其药物警戒存在针对性的法规指导欠缺、药理与毒理研究不充分、真实世界数据缺乏、不良反应识别困难以及数据收集与共享机制不健全等挑战。结论 需通过健全法规体系、深化非临床与临床研究、建立真实世界数据平台、开发智能化风险识别工具以及推动数据共享与国际合作,多维度完善辐射防治药物的药物警戒体系,以保障用药安全与有效。

关键词: 辐射防治药物, 辐射, 辐射缓解剂, 辐射防护剂, 辐射治疗剂, 药物警戒, 药品不良反应

Abstract: Objective To analyze the challenges facing pharmacovigilance related to radioprotective drugs and propose optimization strategies so as to promote safe and rational clinical use of drugs. Methods Through literature review, radioprotective drugs and the identified representative agents were categorized. Major problems with pharmacovigilance were summarized while corresponding countermeasures were proposed. Results Radioprotective drugs were classified into three major categories: radioprotective agents, radiation mitigators, and radiotherapeutic agents. Five major challenges were identified: inadequate regulatory frameworks, insufficient research on pharmacology and toxicology, the lack of real-world data, difficulties in detecting adverse reactions, and imperfect data collection and sharing mechanisms. Conclusion A multidimensional approach is required to enhance the pharmacovigilance system for radioprotective drugs by strengthening regulatory frameworks, broadening nonclinical and clinical research, establishing real-world data platforms, developing intelligent risk identification tools, and promoting data sharing and international collaboration to ensure medication safety and efficacy.

Key words: Radioprotective Drugs, Radiation, Radiation Mitigators, Radioprotective Agents, Radiotherapeutic Agents, Pharmacovigilance, Adverse Drug Reaction

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