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

作　　者：李芳 杜小换[1] 尚翔[2] 王文娟 周密 朱增燕[1] LI Fang;DU Xiaohuan;SHANG Xiang;WANG Wenjuan;ZHOU Mi;ZHU Zengyan(Dept.of Pharmacy,Children’s Hospital of Soochow University,Jiangsu Suzhou 215002,China;Dept.of Pharmacy,Suzhou Guangji Hospital,Jiangsu Suzhou 215003,China)

机构地区：[1]苏州大学附属儿童医院药剂科,江苏苏州215002 [2]苏州市广济医院药剂科,江苏苏州215003

出　　处：《中国药房》2024年第11期1369-1373,共5页China Pharmacy

基　　金：苏州市科技计划项目(No.SLJ2021015)。

摘　　要：目的 挖掘和分析伊立替康上市后在成人和儿童群体中的药物不良事件(ADE)信号,为临床安全用药提供参考。方法提取美国FDA不良事件报告系统数据库中2004年第1季度至2023年第1季度的伊立替康ADE报告,采用报告比值比法和比例报告比值比法挖掘该药的风险信号,分别对患者年龄<18岁(儿童)和≥18岁(成人)的ADE报告及信号进行统计分析。结果 共挖掘到8 013份以伊立替康为首要怀疑药物的ADE报告,其中成人与儿童ADE报告分别有7 656、357份,分别挖掘出518、75个ADE信号,主要累及胃肠系统疾病、血液及淋巴系统疾病和全身性疾病及给药部位各种反应等系统器官分类。信号频度排前20位的ADE信号在伊立替康的药品说明书中大部分有记载;周围神经病、口腔黏膜炎、肺栓塞、表皮痣综合征、生殖毒性等是成人中新的ADE信号,而高血压、进展性肿瘤、肿瘤溶解综合征、栓塞等是儿童中新的ADE信号。结论 临床应用伊立替康时应警惕说明书未提及的上述新的可疑高风险信号。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 8013 ADE reports with irinotecan as the primary suspect drug were identified,including 7656 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 

分 类 号：R969.3[医药卫生—药理学]