基于JADER数据库的罗沙司他不良事件信号挖掘与分析

Signal mining and analysis of adverse events of roxadustat based on the JADER database

目的基于JADER数据库挖掘罗沙司他的不良事件信号,评价罗沙司他在真实世界中的安全性,以期为临床合理用药提供参考。方法收集JADER数据库自2004年4月—2024年8月的不良事件报告数据,采用报告比值比法和综合标准法进行不良事件信号挖掘。结果共收集到以罗沙司他为“可疑”药物的不良事件报告2997份,男性所占比例略高于女性,年龄集中在65~84岁。共挖掘出101个不良事件信号,其中发生频数居前的不良事件信号与说明书基本一致,包括甲状腺功能减退症、大脑梗死、深静脉血栓形成、高钾血症等。除此之外还发现了一些新的可疑不良反应,如黄疸、高胆红素血症、视网膜出血等。结论临床上应加强监测患者的甲状腺功能指标、心脑血管功能、血钾水平以及感染症状与体征,并警惕说明书未提及的不良事件信号,保障患者用药安全。

Objective To detect adverse event signals of roxadustat based on the JADER database and evaluate its safety in the real world,so as to provide evidence for rational use of medicines.Methods The adverse event reports from April 2004 to August 2024 were collected.The adverse event signal were analyzed using the reporting odds ratio method and comprehensive standard method.Results A total of 2997 adverse event reports related to roxadustat as“suspected”were collected.There was a slightly higher proportion of males.The age was mainly concentrated between 65 and 84 years.A total of 101 adverse event signals were identified.The signals with high frequency were consistent with the instruction basically,including hypothyroidism,cerebral infarction,deep vein thrombosis,hyperkalemia,etc.Additionally,some new suspicious adverse reactions were discovered,such as jaundice,hyperbilirubinemia,retinal hemorrhage,etc.Conclusion In clinical practice,healthcare professionals should pay attention to patients'thyroid function indicators,cardiovascular and cerebrovascular function,blood potassium levels,as well as infection symptoms and signs,and be alter to the adverse event signals not mentioned in the instruction to ensure patient safety.