中国临床药学杂志2024，Vol.33Issue(4)：264-269,6.DOI:10.19577/j.1007-4406.2024.04.006
基于美国FDA不良事件报告系统调研克唑替尼在儿童肿瘤治疗中的安全性
Safety investigation of crizotinib in pediatric oncology therapy based on the FDA Adverse Event Reporting System database
摘要
Abstract
AIM To mine and analyze the adverse event signals of crizotinib for the treatment of pediatric tumors based on the U.S.FDA Adverse Event Reporting System(FAERS)database,providing reference for the safe and rational use of drugs in clinical practice.METHODS Cases of crizotinib for pediatric patients were retrieved based on FAERS data from the third quarter of 2011 to the third quarter of 2022.The reporting odds ratio(ROR)method and the proportional reporting ratio(PRR)from disproportionality analysis were used to detect the signal of adverse drug events(ADE)reports.RESULTS A total of 103 cases of crizotinib in treating pediatric tumors with 312 preferred terminologies(PT)involving 20 system organ classifications(SOC)were obtained.The main focus wss on gastrointestinal diseases,various examinations,systemic diseases and various reactions at the site of administration,infections and infectious diseases,and metabolic and nutritional diseases.New PT such as sepsis,discharge of secretions,hypoxia were uncovered,as well as new SOC such as ear and vagus disorders,endocrine system disorders,immune system disorders with various types of injury,poisoning,and operational complications.The top 5 most frequently reported PT were neutropenia,diarrhea,death,nausea,and decreased neutrophil count.The top 5 PT in terms of signal strength were esophagitis,discharge of secretions,decreased neutrophil count,hypoxia,and visual impairment.CONCLUSION Based on pharmacovigilance studies of the FAERS database,attention should be paid to the high frequency and newly emerged adverse events that occured in children using crizotinib.Prior to initiation of crizotinib,pediatric patients should receive a baseline ophthalmologic examination and be monitored for ocular toxicity during subsequent therapy.关键词
克唑替尼/美国FDA不良事件报告系统/真实世界研究Key words
crizotinib/FAERS database/real-world research引用本文复制引用
李江,毛凯丽,叶清清,邓志辉,赵敏,谢升阳..基于美国FDA不良事件报告系统调研克唑替尼在儿童肿瘤治疗中的安全性[J].中国临床药学杂志,2024,33(4):264-269,6.基金项目
浙江省医师协会临床合理用药专委会临床研究基金项目(编号YS2022-3-013) （编号YS2022-3-013）
