中国药房2024，Vol.35Issue(11)：1369-1373,5.DOI:10.6039/j.issn.1001-0408.2024.11.15
伊立替康在成人和儿童中的ADE信号差异分析
Difference analysis of ADE signal for irinotecan in adults and children
摘要
Abstract
OBJECTIVE To mine and analyze the post-marketing adverse drug event(ADE)signals of irinotecan in adults and children populations,and to provide a reference for clinical safe medication.METHODS ADE reports of irinotecan from the first quarter of 2004 to the first quarter of 2023 in the US FDA adverse event reporting system database were extracted and the risk signals of irinotecan were detected through the reporting odds ratio and proportional reporting ratio.Statistical analysis was performed for ADE reports and signals of patients aged＜18 years(children)and≥18 years(adults).RESULTS A total of 8 013 ADE reports with irinotecan as the primary suspect drug were identified,including 7 656 and 357 ADE reports in adults and children,respectively.A total of 518 and 75 ADE signals were detected in the adults and children,and the mainly involved systems and organs including gastrointestinal disorders,blood and lymphatic system disorders,systemic disorders and various reactions at the administration site,etc.Most of the top 20 ADE signals in terms of frequency were documented in the drug instructions of irinotecan.New ADE signals in adults included peripheral neuropathy,oral mucosal inflammation,pulmonary embolism,epidermal nevus syndrome and reproductive toxicity,while hypertension,progressive neoplasms,tumor lysis syndromes,and embolism were new ADE signals in children.CONCLUSIONS The above new suspected high-risk signals not mentioned in the instructions should raise a high level of alertness in clinical practice of irinotecan.关键词
伊立替康/药物不良事件/FAERS数据库/风险信号/儿童Key words
irinotecan/drug adverse events/FAERS database/risk signals/children分类
医药卫生引用本文复制引用
李芳,杜小换,尚翔,王文娟,周密,朱增燕..伊立替康在成人和儿童中的ADE信号差异分析[J].中国药房,2024,35(11):1369-1373,5.基金项目
苏州市科技计划项目(No.SLJ2021015) （No.SLJ2021015）
