孙坤 1谢吉科 1颜妍 1李芳 1唐婧 1毛乾泰1
作者信息
- 1. 清华大学北京清华长庚医院 药学部,北京,102218
- 折叠
摘要
Abstract
Objective To explore the signals of adverse events(ADE)related to mirvetuximab soravtansine in the real world,and to provide reference for clinical medication safety.Methods Data from Q3,2004 to Q3,2024,in the US Food and Drug Administration Adverse Event Reporting System(FAERS)database were retrieved for disproportionality and Bayesian analysis.Reporting odds ratio method and Bayesian confidence interval progressive neural network method were used to analyze the occurrence of ADE.Results A total of 26 ADE signals were detected,involving 355 ADE reports,in re-lation to 9 system organ classes(SOCs).Among patients with documented gender,females reported more adverse drug events(ADEs)than males.In cases with available age data,the majority of ADEs occurred in individuals aged over 45 years.ADE reports were predominantly concentrated between 2023 and 2024.The predominantly involved SOCs included eye disorders,various nervous system disorders,respiratory/thoracic/mediastinal disorders,and gastrointestinal disorders.High-frequency ADE signals comprised pneumonitis,peripheral neuropathy,blurred vision,abdominal pain,and keratopa-thy.Six new suspected adverse reactions that were not recorded before were found,including pulmonary fibrosis,colitis,ex-travasation,oxygen saturaion decreased,etc.Conclusion The common adverse reactions of mirvetuximab soravtansine in the real world are consistent with the drug instructions,but there are some newly discovered signals with high statistical correla-tion.According to the principle of suspicious report,we should pay attention to such signals in clinical practice.关键词
索米妥昔单抗/FAERS数据库/药物不良事件/信号挖掘Key words
Mirvetuximab soravtansine/FAERS database/Adverse drug events/Signal mining分类
医药卫生
