中国临床药学杂志2025，Vol.34Issue(6)：431-436,6.DOI:10.19577/j.1007-4406.2025.06.005
于FAERS数据库的儿童达沙替尼不良事件信号挖掘与分析
Mining and analysis of adverse reaction signals of dasatinib in pediatric patients based on the FDA adverse event reporting system database
摘要
Abstract
AIM To mine and analyze dasatinib-associated adverse drug events(ADEs)of pediatric patients in real-world scenatios,informing clinical strategies for safer pharmacotherapy.METHODS Cases of dasatinib for pediatric patients were retrieved based on the FDA adverse event reporting system(FAERS)data from Q2/2006 to Q2/2024.The reporting odds ratio(ROR)method and the proportional reporting ratio(PRR)from disproportionality analysis were used to detect the signal of ADEs.ADE signals were prioritized through signal frequency and signal intensity.RESULTS A total of 1 060 ADE reports(including 424 pediatric cases)with 50 preferred terms(PT)involving 12 system organ classes(SOCs)were identified.Undocumented ADEs like hyponatremia(9 cases),growth retardation(10 cases)and hydrocephalus(4 cases)were observed.Temporal analysis revealed 31.8％(42/132)of ADEs occurred within the first treatment month,with a median time-to-onset of 53 days.Pharmacovigilance analysis revealed significantly attenuated signal intensity and fewer reported cases for pleural effusion in pediatric populations compared to adults.CONCLUSION During clinical use of dasatinib,attention should be paid to non-labeled ADEs associated with dasatinib therapy,particularly growth retardation parameters.The risk of pediatric ADEs associated with dasatinib increases in the early stages of treatment and requires more attention in clinical treatment.Compared with adults,the incidence of pleural effusion was lower in pediatric patients.关键词
达沙替尼/药物不良事件/FDA不良事件报告系统/真实世界研究Key words
dasatinib/adverse drug event/FDA adverse event reporting system/real-world research分类
医药卫生引用本文复制引用
耿娜,刘博宇,张晓红,黄琳..于FAERS数据库的儿童达沙替尼不良事件信号挖掘与分析[J].中国临床药学杂志,2025,34(6):431-436,6.基金项目
北京市自然科学基金面上项目(编号7242210) （编号7242210）
