医疗机构制剂不良反应监测与评价系统构建及初步实践

doi:10.19803/j.1672-8629.20250218

中国药物警戒 ›› 2025, Vol. 22 ›› Issue (9): 1008-1011.
DOI: 10.19803/j.1672-8629.20250218

医疗机构制剂不良反应监测与评价系统构建及初步实践

蒋晓峰¹, 杨淑婷¹, 白丽琴¹, 戚俊¹, 何建雄², 陈文戈³, 梁祖红³, 李渔^1#, 余晓霞^2,*

¹云南省药品评价中心,云南昆明 650106;
²中山大学孙逸仙纪念医院,广东广州 510000;
³广东工业大学机电工程学院,广东广州 510000

收稿日期:2025-04-14 出版日期:2025-09-15 发布日期:2025-09-22
通讯作者: ^*余晓霞,女,硕士,主任药师,治疗药物监测。E-mail: yuxx@mail.sysu.edu.cn。^#为共同通信作者。
作者简介:蒋晓峰,女,本科,主管药师,药品化妆品不良反应监测与评价
基金资助:
云南省药品评价中心项目（Q53A00722001266）; 广州市2024年度市校（院）企联合资助专题项目（2024A03J1199）

Monitoring of Adverse Drug Reactions Caused by Hospital Preparations and Evaluation Systems

JIANG Xiaofeng¹, YANG Shuting¹, BAI Liqin¹, QI Jun¹, HE Jianxiong², CHEN Wenge³, LIANG Zuhong³, LI Yu^1#, YU Xiaoxia^2,*

¹Yunnan Drug Evaluation Center, Kunming Yunnan 650106, China;
²Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou Guangdong 510000, China;
³School of Electromechanical Engineering Guangdong University of Technology, Guangzhou Guangdong 510000, China

Received:2025-04-14 Online:2025-09-15 Published:2025-09-22

摘要/Abstract

摘要： 目的构建智能化不良反应（ADR）监测系统,解决医疗机构制剂ADR监测中存在的漏报、数据碎片化及风险信号滞后等问题,以提升制剂安全管理水平。方法基于Java 2 Platform, Enterprise Edition（J2EE）技术框架,设计多层分布式架构系统,整合医院信息系统（HIS）与中国医院药物警戒系统（CHPS）,实现多源异构数据的实时同步与智能分析。通过云南省与广东省2家医疗机构的实证研究评估该系统性能。结果 3 680例服用活血化瘀制剂病例中精准识别ADR发生率为0.54‰,7 950例服用清热解毒制剂病例中主动监测识别出1例ADR。结论初步研究显示该系统能快速筛查出医疗机构制剂ADR风险信息,但仍然需要通过大规模的实证研究验证其监测效能。

关键词: 医疗机构制剂, 药品不良反应, 监测, 药物警戒, 智能算法, 真实世界证据

Abstract: Objective To construct an intelligent adverse drug reaction (ADR) monitoring system for hospital-made preparations in order to prevent underreporting, data fragmentation, and delayed risk signals. Methods Based on Java 2 Platform and Enterprise Edition (J2EE), a multi-layer and distributed architecture system was designed to integrate the Hospital Information System (HIS) with the China Hospital Pharmacovigilance System (CHPS), making possible real-time synchronization and intelligent analysis of multi-source heterogeneous data. Its performance was evaluated through empirical studies conducted at two healthcare institutions in Yunnan and Guangdong. Results Among the 3,680 cases who had used blood-activating and stasis-resolving preparations, the identified incidence rate of ADR was 0.54 per thousand. In the 7,950 cases administered with heat-clearing and detoxifying preparations, one case of ADR was identified via active monitoring. Conclusion This system can quickly identify ADR risk signals associated with hospital preparations, but its performance needs to be verified by large-scale empirical studies.

Key words: Hospital Preparations, Adverse Drug Reactions, Monitoring, Pharmacovigilance, Intelligent Algorithms, Real-World Evidence

中图分类号:

R951
R994.11

蒋晓峰, 杨淑婷, 白丽琴, 戚俊, 何建雄, 陈文戈, 梁祖红, 李渔, 余晓霞. 医疗机构制剂不良反应监测与评价系统构建及初步实践[J]. 中国药物警戒, 2025, 22(9): 1008-1011.

JIANG Xiaofeng, YANG Shuting, BAI Liqin, QI Jun, HE Jianxiong, CHEN Wenge, LIANG Zuhong, LI Yu, YU Xiaoxia. Monitoring of Adverse Drug Reactions Caused by Hospital Preparations and Evaluation Systems[J]. Chinese Journal of Pharmacovigilance, 2025, 22(9): 1008-1011.

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https://zgywjj.magtechjournal.com/CN/Y2025/V22/I9/1008

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医疗机构制剂不良反应监测与评价系统构建及初步实践

Monitoring of Adverse Drug Reactions Caused by Hospital Preparations and Evaluation Systems

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