2020—2024年国家药品不良反应监测年度报告趋势分析

doi:10.19803/j.1672-8629.20250252

摘要/Abstract

摘要： 目的分析近5年我国药品不良反应（ADR）监测年度报告中的数据,并提出改进监测工作的建议,以构建更高效精准的药物警戒体系。方法基于我国国家药品不良反应监测中心发布的2020—2024年度报告数据,对报告数量、报告质量、药品分类、报告主体特点等进行系统梳理与分析。结果近年我国ADR监测在报告数量显著增长和监测网络日趋完善等方面取得积极进展。但在报告主体（尤其是药品上市许可持有人）参与度有待提升、重点人群（如儿童、老年人）用药风险监测待加强、高风险药品（如新型抗肿瘤药、生物制品）安全性评价需深化、信息化与智能化支撑能力建设仍需推进。结论面对当前挑战,持续提升药品安全监测效能的关键在于：①完善ADR相关法规制度体系,着力强化药品上市许可持有人等关键主体的报告责任与能力;②构建儿童、老年等特殊人群用药安全的坚实屏障;③全过程强化高风险药品监管,深化药品不良反应信号挖掘;④大力驱动信息化与智能化技术在监测体系中的融合应用;⑤协同提升公众合理用药素养与药物警戒参与意识。

关键词: 药品不良反应, 药物警戒体系, 高风险药品, 信息化建设, 监测网络, 年度报告

Abstract: Objective To analyze the data from China's Adverse Drug Reaction (ADR) monitoring, explore developments, and propose strategies for building a more efficient and precise pharmacovigilance system. Methods The data from the 2020-2024 annual reports released by the National Adverse Drug Reaction Monitoring Center of China was reviewed and analyzed. Results Substantial progress was made in China's ADR monitoring, such as the huge increases in the number of reports and continuous optimization of the monitoring network. However, challenges persisted, including inadequate participation of reporting entities (especially MAH), insufficient risk monitoring for key populations (e.g., children and the elderly), incomplete safety assessments of high-risk drugs (e.g., novel antitumor agents and biologics), and slow progress in information technology and intelligent capabilities. Conclusion To address these challenges and enhance drug safety surveillance, it is recommended that the regulatory framework for ADR monitoring be updated, responsibilities and abilities for reporting be upgraded in such key entities as MAH, medication safety for vulnerable groups (children/elderly) be prioritized, lifecycle supervision and signal detection for high-risk drugs be enhanced, IT and AI technologies be integrated in monitoring, and literacy about rational medication and awareness of pharmacovigilance be improved.

Key words: Adverse Drug Reaction, Pharmacovigilance System, High-Risk Drugs, Digital System Building, Monitoring Network, Annual Reports

中图分类号:

R951
R994.11

胡骏. 2020—2024年国家药品不良反应监测年度报告趋势分析[J]. 中国药物警戒, 2025, 22(12): 1376-1379.

HU Jun. Takeaways from the National Annual Reports on Adverse Drug Reaction Monitoring (2020-2024)[J]. Chinese Journal of Pharmacovigilance, 2025, 22(12): 1376-1379.

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https://zgywjj.magtechjournal.com/CN/Y2025/V22/I12/1376

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