中国药物警戒 ›› 2024, Vol. 21 ›› Issue (7): 752-758.
DOI: 10.19803/j.1672-8629.20240296

• 药源性心脏毒性研究专栏 • 上一篇    下一篇

基于药品不良反应监测数据的心脏器官伤害风险信号挖掘分析

阿拉腾花1,2,3,4, 王振兴3, 张晓朦1,2, 世伟3, 席成伟3, 王聪慧3, 王立群4, 张冰1,2,*   

  1. 1北京中医药大学中药学院,北京 102488;
    2北京中医药大学中药药物警戒与合理用药研究中心,北京 102488;
    3内蒙古自治区药物警戒中心,内蒙古 呼和浩特 010010;
    4内蒙古大学数学科学学院,内蒙古 呼和浩特 010021
  • 收稿日期:2024-05-08 出版日期:2024-07-15 发布日期:2024-07-31
  • 通讯作者: * 张冰,女,博士,教授·博导,主任医师,中药药物警戒与合理用药。E-mail:zhangbing6@263.net
  • 作者简介:阿拉腾花,女,硕士,副主任蒙药师,药物警戒与民族药安全性评价。
  • 基金资助:
    国家中医药管理局中医药创新团队及人才支持计划子项目（ZYYCXTD-C-202005-11）; 少数民族地区专业技术人才特培计划（内人社办发2022[139]号）; 中国民族医药学会科研项目（2023MY139-07）; 内蒙古自治区药品监督管理局药品安全监管科研项目（NMYJ-KJ-202306）; 国家自然科学基金资助项目（82204643）

Mining and analysis of cardiac disorders risk signals based on adverse drug reaction monitoring data

ALATENG Hua1,2,3,4, WANG Zhenxing3, ZHANG Xiaomeng1,2, SHI Wei3, XI Chengwei3, WANG Conghui3, WANG Liqun4, ZHANG Bing1,2,*   

  1. 1School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China;
    2Center for Pharmacovigilance and Rational Use of Chinese Medicine, Beijing University of Chinese Medicine, Beijing 102488, China;
    3Center for Pharmacovigilance of Inner Mongolia Autonomous Region, Hohhot Inner Mongolia 010010, China;
    4School of Mathematical Sciences, Inner Mongolia University, Hohhot Inner Mongolia 010021, China
  • Received:2024-05-08 Online:2024-07-15 Published:2024-07-31

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摘要： 目的 挖掘与分析药品不良反应监测数据库中可能导致心脏器官伤害的药品不良反应（ADR）风险信号,为临床安全合理用药及药品上市后安全性研究提供参考。方法 提取2021年1月1日至2023年12月31日期间某省药品不良反应监测数据库的ADR报告,进行数据清洗,采用报告比值比（ROR）法进行ADR信号检测,计算ADR累及心脏器官系统药品的ROR值及其95%置信区间,对挖掘出的风险信号进行分析与评价。结果 检索近3年ADR报告共72 398例,排除重复报告及不完整报告,最终纳入分析的累及心脏器官系统ADR报告3 697例。女性患者数量多于男性患者,65岁以上的老年患者用药后发生ADR的例数最多,原患疾病为呼吸系统、胸及纵隔疾病,血管与淋巴管类疾病和心脏器官疾病占比近60%,给药疗程1 d以内的报告超过50%,患者用药当天发生ADR的超60%,不良反应转归情况总体良好。263个药品被纳入分析,ROR法挖掘出可能导致心脏器官伤害风险信号共70个,包含62个说明书记载的已知信号和8个说明书未记载的新的信号。结论 ROR法挖掘本省可能导致心脏器官伤害ADR风险信号,初步产生风险信号,但还需要进一步深入研究予以证实。药物警戒除重点关注可能导致心脏器官伤害的药品外,还应注意患者个体差异、临床用药因素的影响,将药源性心脏风险降至最低,确保用药安全。

关键词: 药品不良反应, 药物警戒, 心脏器官伤害, 风险信号, 报告比值比法, 合理用药

Abstract: Objective To mine and analyze the risk signals of adverse drug reactions (ADR) leading to cardiac disorders in the adverse drug reaction monitoring database in order to provide reference for safe and rational drug use and for research on post-marketing drug safety. Methods The ADR reports from the adverse drug reaction monitoring system database of one province collected between 2021 and 2023 were retrieved and subjected to data cleaning. The reporting odds ratio (ROR) method was employed for detection of ADR signals, and the ROR values and their 95% confidence intervals of drugs causing cardiac disorders risks were calculated. The risk signals mined were analyzed and assessed. Results A total of 72 398 ADR reports were retrieved over the past three years. After excluding duplicate and incomplete reports, 3 697 ADR reports involving the cardiovascular system were finally included in the analysis. Female patients outnumbered male ones, and ADR occurred predominantly in patients over 65 years old after medication. Diseases related to the respiratory system, mediastinal diseases, vascular and lymphatic diseases and heart diseases accounted for nearly 60% of the primary diseases. In over half of the reports, ADR occurred within less than one day of medication, and more than 60% of the ADR occurred on the very day of medication. The overall outcome of adverse reactions was favorable. Among the 263 suspected drugs analyzed, 70 risk signals of cardiac disorders were identified using the ROR method, including 62 anticipated signals documented in the package inserts and 8 unanticipated ones not documented in the package inserts. Conclusion The ROR method is generally reliable for mining and analyzing risk signals of cardiac disorders. However, the signals generated by this method are far from conclusive in that their credibility and robustness are influenced by the quantity, quality, and confounding factors of the data. In addition to focusing on drugs that may cause cardiac disorders, pharmacovigilance personnel should also take into consideration the differences between individual patients and clinical medication risk factors to minimize drug-induced cardiac risks and ensure safe medication.

Key words: adverse drug reaction, pharmacovigilance, cardiac disorders, risk signal, reporting odds ratio, rational drug use

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