河北医科大学学报 ›› 2024, Vol. 45 ›› Issue (12): 1380-1386.doi: 10.3969/j.issn.1007-3205.2024.12.004

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基于openFDA数据库老年患者质子泵抑制剂不良事件的信号挖掘与分析

  

  1. 1.河北医科大学药学院临床药学教研室，河北 石家庄 050017；2.河北省秦皇岛市第一医院药学部，河北 秦皇岛 066000

  • 出版日期:2024-12-25 发布日期:2025-01-03
  • 作者简介:常亚男(1997-)，女，满族，河北秦皇岛人，河北医科大学药学院理学硕士研究生，从事临床药学研究。
  • 基金资助:
    河北省药学会医院药学专项科研项目（2022-Hbsyxhqjyxms16）；秦皇岛市科学技术研究与发展计划项目（202301A141）

Mining and analysis of adverse drug event signals of proton pump inhibitors in elderly patients based on openFDA database

  1. 1.College of Pharmacy, Hebei Medical University, Shijiazhuang 050017, China； 2.Department of 
    Pharmacy， the First Hospital of Qinhuangdao City, Hebei Province, Qinhuangdao 066000, China

  • Online:2024-12-25 Published:2025-01-03

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摘要： 目的 对老年患者使用质子泵抑制剂（proton pump inhibitors，PPIs）进行不良事件信号的挖掘，为老年患者PPIs的临床安全合理使用提供参考。
方法 采用报告比值比法（reporting odds ratio,ROR）和综合标准法（Medicines and Healthcare products Regulatory Agency，MHRA）对openFDA数据库2017年1月1日—2022年9月30日收集的不良事件报告进行分析，挖掘其中5种PPIs的不良事件信号。
结果 共检测到177个不良事件信号，涉及15个常用的系统。其中雷贝拉唑共68个信号、兰索拉唑35个、泮托拉唑33个、奥美拉唑22个和埃索美拉唑19个。主要为肾脏及泌尿系统疾病31个信号（36.64%）；胃肠系统疾病涉及25个信号（13.04%）；代谢及营养类疾病19个信号(9.28%)。雷贝拉唑产生的信号种类和个数最多，主要集中在呼吸系统、胸及纵隔疾病。
结论 老年患者使用PPIs时，除说明书已提及的不良反应外，还应监测肾功能、电解质水平、呼吸系统感染等相关风险，并采取一定的预防和治疗措施，或应避免应用于高危人群和更换相对安全的PPIs，以确保患者安全用药。


关键词: 质子泵抑制剂, openFDA, 老年患者, 不良事件信号挖掘

Abstract: Objective To mine adverse drug event(ADE) signals for the use of proton pump inhibitors (PPIs) in elderly patients, and to provide a reference for the safe and rational clinical use of PPIs in elderly patients. 
Methods Adverse event reports collected in the openFDA database from January 1, 2017 to September 30, 2022 were analyzed using both the reporting odds ratio (ROR) method and Medicines and Healthcare products Regulatory Agency (MHRA) to mine adverse event signals of five PPIs. 
Results A total of 177 ADE signals were detected, involving 15 commonly used systems. Of these, there were a total of 68 signals for rabeprazole, 35 for lansoprazole, 33 for pantoprazole, 22 for omeprazole and 19 for esomeprazole. There were mainly 31 signals (36.64%) for renal and urinary disorders,25 signals (13.04%) for gastrointestinal disorders, and 19 signals (9.28%) for metabolic and nutritional disorders.Rabeprazole produced the highest variety and number of signals, mainly involving respiratory, thoracic and mediastinal disorders. 
Conclusion For PPIs used in the elderly, in addition to the ADE already mentioned in the specification, the risks associated with renal function, electrolyte levels, and respiratory infections should be monitored, and certain preventive and therapeutic measures should be taken, or the application of PPIs should be avoided in high-risk populations and replaced by relatively safe PPIs, in order to ensure patientsafety. 


Key words: proton pump inhibitors, openFDA, elderly patients, adverse drug event signal mining

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