广州医药 ›› 2025, Vol. 56 ›› Issue (1): 106-112.DOI: 10.20223/j.cnki.1000-8535.2025.01.015

• 论著 • 上一篇    下一篇

基于FAERS数据库的美托洛尔不良事件信号挖掘

文立蓉, 段雪玉, 吴广俊, 潘建梅, 刘晓波   

  1. 大理大学药学院(云南大理 671000)
  • 收稿日期:2024-02-24 出版日期:2025-01-20 发布日期:2025-02-13
  • 通讯作者: 刘晓波,E-mail:yndlxb@126.com

Signal data mining of metoprolol adverse events based on FAERS

WEN Lirong, DUAN Xueyu, WU Guangjun, PAN Jianmei, LIU Xiaobo   

  1. College of Pharmacy,Dali University,Dali 671000,China
  • Received:2024-02-24 Online:2025-01-20 Published:2025-02-13

摘要: 目的 挖掘使用美托洛尔后的药物不良事件(ADE),为临床合理用药提供参考意见。方法 对美国食品药品管理局(FDA)FDA药物ADE报告系统(FAERS)数据库进行信号挖掘,采用报告比值比法和比例报告比值法,分析FAERS数据库中2004年第1季度至2023年第2季度关于美托洛尔的ADE报告。结果 在FAERS数据库中收集到美托洛尔相关ADE共24 184例、667个阳性信号,共涉及27个系统器官分类。ADE严重报告共16 766(占69.33%),ADE报告频次排名前3的分别是头晕、心动过缓、呼吸困难。结论 美托洛尔的不良反应主要集中在全身性疾病及给药部位各种反应、心脏器官疾病和各类损伤。在使用美托洛尔过程中发生ADE时,应该及时采取相应的干预措施。

关键词: 美托洛尔, 药物不良事件, 信号挖掘, FDA不良事件报告系统

Abstract: Objective To explore the adverse drug events(ADEs)after the use of metoprolol and provide reference opinions for clinical rational drug use.Methods Signal mining was conducted on the FDA Adverse Event Reporting System(FAERS)database in the United States.The reporting ratio method and proportional reporting ratio method were used to analyze ADEs reports related to metoprolol in the FAERS database from the first quarter of 2019 to the second quarter of 2023.Results A total of 24 184 cases of metoprolol related ADEs were collected in the FAERS database,with 667 positive signals and a total of 27 system organ class involved.Conclusions The adverse reactions of metoprolol mainly focus on systemic diseases,various reactions at the administration site,heart organ diseases,and various injuries.It is recommended that timely intervention measures should be taken when ADE occurs during the use of metoprolol.

Key words: metoprolol, adverse drug events, signal mining, US Food and Drug Administration adverse event reporting system