摘要
目的 基于美国食品药品监督管理局(FDA)不良反应事件报告系统(FDA adverse event reporting system, FAERS)对厄达替尼得相关不良反应事件进行数据挖掘,为厄达替尼的临床应用提供参考依据。方法 挖掘FAERS数据库2019年第2季度—2022年第2季度的厄达替尼的药品不良事件数据,并采用报告比值法(ROR)和比例报告比值法(PRR)对挖掘的数据进行分析。结果 共收集到以厄达替尼为首要怀疑药物的不良时间报告593例。其中男性所占比例(50.08%)高于女性所占比例(35.08%)。年龄多集中在46~80岁。上报国家以美国为主(77.07%)。将无效信号排除后,共得到药品不良事件信号71个,依据MedDRA对该71个信号的首选术语(PT)进行分类,共涉及到16个系统器官分类(SOC),排名前5位的依次是全身性疾病及给药部位各种反应、皮肤及皮下组织类疾病、胃肠紊乱疾病、社会环境及感染及侵染类疾病。结论厄达替尼常见的药品不良事件与说明书记载的无较大差异,具有一致性,但涉及到的SOC分类与说明书具有一定的差异性,可为临床安全用药提供参考。
Objective To conduct data mining of adverse events related to erdafitinib based on the FDA adverse event reporting system(FAERS), so as to provide reference for future clinical application of erdafitinib. Methods Adverse drug event data of erdafitinib in FAERS database from second quarter of 2019 to 2022 were mined, and the mined data were analyzed by ROR and PRR methods.Results A total of 593 cases of adverse time reports with erdafitinib as the primary suspected drug were collected. The proportion of males(50.08%) was higher than that of females(35.08%). Most of them are 46 — 80 years old. The United States was the main reporting country(77.07%). After excluding invalid signals, a total of 71 adverse drug event signals were obtained, which were classified according to MedDRA’s preferred term(PT), involving 16 SOC. The top 5 were systemic diseases and reactions at the site of administration, skin and subcutaneous tissue diseases, gastrointestinal disorders, social environment, and infections and infections.Conclusion The common adverse drug event signals of erdafitinib are not significantly different from those recorded in the instructions and are consistent, but the SOC classification involved is somewhat different from the instructions, which can provide a reference for safe clinical use.
作者
杨芝芳
尹小娟
杨沙
刘佩
寇楠
何亚楠
李惠敏
李凤超
温慧敏
YANG Zhi-fang;YIN Xiao-juan;YANG Sha;LIU Pei;KOU Nan;HE Ya-nan;LI Hui-min;LI Feng-chao;WEN Hui-min(Department of Pharmacy,Sichuan Province Orthopedic Hospital,Chengdu 610000,China)
出处
《现代药物与临床》
CAS
2023年第3期709-713,共5页
Drugs & Clinic
关键词
厄达替尼
药品不良事件信号
数据挖掘
身性疾病及给药部位各种反应
皮肤及皮下组织类疾病
erdafitinib
adverse drug event signal
data mining
systemic diseases and reactions at the site of administration
skin and subcutaneous tissue diseases
