梁春宏 1张学艳 2周丽娟 2彭评志 1张维权 1肖笛3
作者信息
- 1. 玉林市第一人民医院 药物临床试验机构,广西 玉林,537000
- 2. 玉林市第一人民医院 临床药学科,广西 玉林,537000
- 3. 中南大学湘雅医院 药学部,湖南 长沙,410008
- 折叠
摘要
Abstract
Objective To explore the positive post-marketing adverse drug event(ADE)signals of sacituzumab govite-can,in order to provide a basis for the safety assessment.Methods Sacituzumab govitecan-associated ADE reports from Q2 2020 to Q2 2024 were obtained from the FDA Adverse Event Reporting System(FAERS)for ADE signal mining using the disproportionality method.Furthermore,age and gender differences were investigated in the reporting of ADEs by sub-groups.Results A total of 3 332 ADE reports primarily suspected to be associated with sacituzumab govitecan were includ-ed,with 69 ADE signals detected across 17 system organ classes(SOCs).The majority of reports involved female patients.The median time to ADE occurrence was 14 days after medication.Male patients showed significantly higher proportions of se-rious reports and greater risks of life-threatening ADEs and hospitalization-requiring events compared to female patients(P<0.001).The most frequently affected SOCs included general disorders and administration site conditions(40.56%),blood and lymphatic system disorders(18.83%),investigations(13.01%),and gastrointestinal disorders(12.78%).The most frequently reported ADE signals were disease progression,death,diarrhea,neutropenia and weight fluctuation.The signals with the highest relevance were neutropenic colitis,cholinergic syndrome,weight fluctuation,and vascular device obstruction.26 ADE signals not mentioned in drug labelswere identified,involving SOCs such as vascular and lymphatic vascular disorders,renal and urinary disorders,and eye disorders,as well as specific signals such as accelerated heart rate,perforation of the large intestine,and cholestasis.Conclusion In this study,the gender,age,time of occurrence,and system-organ distribution characteristics of Sacituzumab govitecan-related ADEs were discovered.The results of the study contribute to the drug's safe-ty information and provide a scientific basis for clinical medication decision-making and adverse reaction management.关键词
戈沙妥珠单抗/FAERS/药品不良反应/信号挖掘Key words
Sacituzumab govitecan/FAERS/Adverse drug event/Signal mining分类
医药卫生
