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

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1431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 adverse 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 ratio(PRR)methods were used to mine the risk signals of Pralsetinib adverse reaction.Results A total of 1431 cases of adverse events of Pralsetinib were found by ROR and PRR methods,including some potential adverse event signals not mentioned 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.