首页|基于FAERS的普拉替尼上市后不良反应事件信号挖掘与分析

基于FAERS的普拉替尼上市后不良反应事件信号挖掘与分析

Mining and analysis of the adverse event reports signals for Pralsetinib based upon FAERS

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目的 通过普拉替尼不良反应事件进行数据分析,挖掘并探究其致严重不良事件的危险因素.方法 根据美国食品药品监督管理局不良事件报告系统(FAERS)数据库中2020年第3季度至2023年第2季度共12个季度的不良反应数据,采用报告比值法(ROR)和比例报告比值法(PRR)挖掘普拉替尼不良反应风险信号.结果 采用ROR法、PRR法挖掘到普拉替尼不良反应事件1 431例,其中包括一些说明书未提及的潜在不良反应信号,如心肌坏死标志物增加、胸水、认知障碍等,在临床用药过程中需警惕.结论 采用ROR法、PRR法能够有效挖掘出普拉替尼的不良反应风险信号,为临床安全用药提供参考.
Objective Data analysis of Pralsetinib adverse event was conducted to explore the risk factors for serious ad-verse events.Methods According to the adverse reaction data of 12 quarters from the 3rd quarter of 2020 to the 2nd quarter of 2023 in FDA Adverse Event Reporting System(FAERS)database,reporting odds ratio(ROR)and proportional reporting ra-tio(PRR)methods were used to mine the risk signals of Pralsetinib adverse reaction.Results A total of 1 431 cases of ad-verse events of Pralsetinib were found by ROR and PRR methods,including some potential adverse event signals not men-tioned in the instructions,such as increased markers of myocardial necrosis,pleural effusion,cognitive impairment,etc.,which should be vigilant in clinical administration.Conclusion ROR and PRR methods can effectively excavate the risk signal of Pralsetinib's adverse reactions,and provide reference for clinical safe drug use.

PralsetinibAdverse event reports signalReporting odds ratioProportional reporting ratio

陈曦、杜俊楠

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中国航空工业集团公司洛阳电光设备研究所综合门诊部,河南洛阳 471000

普拉替尼 不良事件信号 报告比值比法 比例报告比值法

2024

中国当代医药
中国保健协会 当代创新(北京)医药科学研究院

中国当代医药

影响因子:1.215
ISSN:1674-4721
年,卷(期):2024.31(11)
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