氯苯唑酸在真实世界中的不良事件：基于2019年至2023年FAERS数据库的药物警戒研究
Adverse Events Associated with Tafamidis in the Real-World: Pharmacovigilance Study of FAERS Database from 2019 to 2023
DOI: 10.12677/acm.2025.15102923, PDF,    科研立项经费支持
作者: 胡 诚, 李 浩, 刘 源, 谭 历, 苏 立*：重庆医科大学附属第二医院心血管内科，重庆
关键词: 氯苯唑酸；FDA不良事件报告系统；不良事件；数据挖掘；Tafamidis； FAERS； Adverse Events； Data Mining
摘要: 目的：本研究旨在利用并分析美国食品药品监督管理局不良事件报告系统，以评估氯苯唑酸在真实世界中的药物安全性。方法：提取2019年第二季度至2023年第三季度期间收录于FAERS数据库的报告，进行描述性分析与非比例分析。采用报告比值比(reporting odds ratio, ROR)在优选术语(preferred term, PT)和系统器官分类(system organ class, SOC)两个层级进行安全性信号检测。通过Weibull形状参数(Weibull Shape Parameter, WSP)检验分析发病时间曲线的特征。采用Kaplan-Meier法评估氯苯唑酸相关不良事件(adverse events, AEs)的累积发生率。并根据报告者是否为医疗专业人员及患者性别进行亚组分析。结果：自2019年第二季度至2023年第三季度，FAERS数据库共收录7568份以氯苯唑酸为主要怀疑药物(primary suspect, PS)的不良事件报告。在报告频次前50位的不良事件中，共识别出16个具有显著信号的不良事件。其中，痛风为ROR值最高的不良事件(ROR = 6.16)。氯苯唑酸相关不良事件的中位发病时间为184天，WSP检验结果显示为早期失效率模式。此外，本研究还发现男性与女性患者在不良事件方面存在差异。结论：本研究不仅识别出已知的显著信号，还发现了多个意料之外的显著信号，并指出氯苯唑酸相关不良事件的风险随时间推移而降低。本研究有助于提升临床专业人员对氯苯唑酸安全性特征的认识。
Abstract: Objective: This study aims to utilize and analyze the FAERS database to investigate the real-world drug safety of tafamidis. Methods: Reports received in the FAERS database between Q2 2019 and Q3 2023 were extracted for descriptive analysis and disproportionality analysis. Safety signal detection was performed using the Reporting Odds Ratio (ROR) at both the Preferred Term level and the System Organ Class level. The characteristics of the time-to-onset curve were analyzed using the Weibull Shape Parameter (WSP) test. The cumulative incidence of tafamidis-related adverse events (AEs) was assessed using the Kaplan-Meier method. Subgroup analyses were conducted based on whether the reporter was a healthcare professional and the patient’s gender. Results: From Q2 2019 to Q3 2023, the FAERS database received 7568 reports of AEs involving tafamidis as the primary suspect (PS). Among the top 50 most frequently reported AEs, 16 were identified as significant signals. Gout was the AE with the highest ROR value (ROR 6.16). The median time to onset for tafamidis-related AEs was 184 days, and the WSP test indicated an early failure-type profile. Additionally, this study provided evidence of differences in AEs between male and female subgroups. Conclusion: The study not only identified known significant signals but also several unexpected significant signals, and found that the risk of tafamidis-related AEs decreases over time. This study helps enhance clinical professionals’ understanding of the safety profile of tafamidis.
文章引用：胡诚, 李浩, 刘源, 谭历, 苏立. 氯苯唑酸在真实世界中的不良事件：基于2019年至2023年FAERS数据库的药物警戒研究 [J]. 临床医学进展, 2025, 15(10): 1580-1595. https://doi.org/10.12677/acm.2025.15102923

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