基于FAERS数据库的噻托溴铵心血管不良事件信号挖掘
Signal Mining and Analysis of Cardiovascular Adverse Events of Tiotropium Bromide Based on the FAERS Database
DOI: 10.12677/acm.2024.1482264, PDF,    国家自然科学基金支持
作者: 秦宏花：大理大学药学院，云南 大理；云南省第三人民医院药剂科，云南 昆明；郭海嬿, 王 莹：大理大学药学院，云南 大理；佟晓娜*, 李海峰：云南省第三人民医院药剂科，云南 昆明
关键词: 噻托溴铵；FAERS；信号挖掘；不良事件报告系统；Tiotropium Bromide； FAERS； Signal Mining； Adverse Event Reporting System
摘要: 目的：通过美国FDA不良事件报告系统(FAERS)数据库，挖掘噻托溴铵心血管不良事件信号，为用药监护提供依据。方法：采用报告比值比法(ROR)对FAERS数据库中于2004年第一季度至2023年第三季度上报的噻托溴铵心血管不良事件进行挖掘及分析。结果：共获得噻托溴铵心血管不良事件报告3881例，年龄主要在65~75岁，女性多于男性，报告国家以美国和加拿大为主。采用ROR法共得到噻托溴铵心血管不良事件信号19个，主要表现为心肌梗死、房颤、充血性心力衰竭等。结论：噻托溴铵引发心血管不良事件存在一定的风险，临床使用时应加强早期监测。
Abstract: Objective: To investigate and assess the risk signals of tiotropium bromide cardiovascular adverse events through the US FDA Adverse Event Reporting System (FAERS) database. Methods: To mine and analyze the cardiovascular adverse events reported from the first quarter of 2004 to the third quarter of 2023 using the reported odds ratio (ROR). Results: A total of 3881 cardiovascular adverse events of tiotropium bromide were reported, mainly aged from 65 to 75 years, more women than men, and the reported countries were mainly the United States and Canada. A total of 19 cardiovascular adverse event signals of tiotropium bromide were obtained by ROR method, mainly manifested as myocardial infarction, atrial fibrillation, and congestive heart failure. Conclusion: Tiotropium bromide has a certain risk of cardiovascular adverse events, and early monitoring should be strengthened in clinical use.
文章引用：秦宏花, 郭海嬿, 佟晓娜, 王莹, 李海峰. 基于FAERS数据库的噻托溴铵心血管不良事件信号挖掘[J]. 临床医学进展, 2024, 14(8): 653-659. https://doi.org/10.12677/acm.2024.1482264

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