中国药物警戒 ›› 2025, Vol. 22 ›› Issue (9): 1034-1039.
DOI: 10.19803/j.1672-8629.20240521

• 安全与合理用药 • 上一篇    下一篇

基于美国FAERS数据库的罗莫单抗不良事件信号分析

王仪1, 任为联2, 杜海涛1, 王平1,*   

  1. 1山东省中医药研究院中药药理研究所,山东 济南 250014;
    2济南市儿童医院儿科,山东 济南 250013
  • 收稿日期:2024-07-26 发布日期:2025-09-22
  • 通讯作者: * 王平,女,博士,研究员,中药药理学。E-mail: wangpingjinan@163.com
  • 作者简介:王仪,女,硕士,主管药师,药学研究。
  • 基金资助:
    山东省重点研发计划（科技示范工程）（2021SFGC1205）; 济南市“新高校20条”资助项目（202228121、202333006）; 泰山学者项目（tstp20231239）

Mining and Analysis of Adverse Drug Event Signals of Romosozumab Based on FAERS Database

WANG Yi1, REN Weilian2, DU Haitao1, WANG Ping1,*   

  1. 1Institute of Pharmacology of Traditional Chinese Medicine, Shandong Academy of Chinese Medicine, Jinan Shandong 250014, China;
    2Department of Pediatrics, Jinan Children's Hospital, Jinan Shandong 250013, China
  • Received:2024-07-26 Published:2025-09-22

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摘要： 目的 检索美国食品药品监督管理局（Food and Drug Administration, FDA）不良事件报告系统（Adverse Event Reporting System, FAERS）数据库,分析罗莫单抗（Romosozumab）相关药物不良事件（Adverse Drug Event, ADE）,为临床用药提供参考。方法 回顾性查询2019年4月1日至2024年1月31日的美国FAERS数据库,提取Romosozumab相关报告。采用报告比值比（Reporting Odds Ratio, ROR）、比例报告比（Proportional Reporting Ratio, PRR）、贝叶斯可信区间递进神经网络（Bayesian Confidence Propagation Neural Network, BCPNN）和多项式伽马泊松分布缩减（Multi-Item Gamma Poisson Shrinker, MGPS）等方法识别和评估Romosozumab相关ADE。结果 共检索到8 432 351例ADE报告,其中7 477例Romosozumab“主要疑似”报告。Romosozumab在16个系统-器官（System Organ Class, SOC）中关联195个ADE信号,主要涉及损伤/中毒、全身性疾病、肌肉骨骼疾病和心脏疾病。常见的ADE包括骨折、骨密度异常、注射部位反应、关节痛、肢体疼痛和心脏事件。此外,一些未在说明书中记载的ADE,如椎体压缩骨折、桡骨骨折、血甲状旁腺素升高和肾功能损害,也显示出较高的信号值。Romosozumab的严重事件包括住院和死亡。结论 本研究确认Romosozumab相关的常见ADE,临床需注意未在药品说明书中记载的ADE,如新的骨折或骨密度异常,并采取相应预防措施。

关键词: 罗莫单抗, 美国食品药品监督管理局不良事件报告系统, 药品不良事件, 信号分析, 药物警戒, 报告比值比, 比例报告比, 贝叶斯可信区间递进神经网络, 多项式伽马泊松分布缩减

Abstract: Objective To investigate romosozumab-related adverse drug events (ADE) in the real world based on the FDA Adverse Event Reporting System (FAERS) in order to contribute to management of safety of clinical drugs. Methods The FAERS database was searched for romosozumab-related articles that were published between April 1, 2019 and January 31, 2024. Romosozumab-related ADE were identified and evaluated using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). Results A total of 8 432 351 reports of ADE were retrieved, 7 477 of which identified romosozumab as the “primary suspect”. Romosozumab was associated with 195 ADE across 16 system organ classes (SOCs), involving injuries and poisoning, general disorders, musculoskeletal and connective tissue disorders, and cardiac disorders. Common ADE included fractures, abnormal bone density, injection site reactions, arthralgia, limb pain and cardiac events. Additionally, some ADE that were not mentioned in the instruction manual, such as vertebral compression fractures, radial fractures, elevated parathyroid hormone and renal dysfunction, showed significant signals. Serious events associated with Romosozumab included hospitalization and death. Conclusion This study has confirmed common ADE associated with romosozumab and identified potential safety risks in actual clinical practices. Physicians and pharmacists should be alert to ADE signals not mentioned in the instructions, such as new fractures or bone density abnormalities, and take precautions.

Key words: Romosozumab, FAERS, Adverse Drug Events, Signal Detection, Pharmacovigilance, Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, Multi-Item Gamma Poisson Shrinker

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