基于美国FAERS数据库和日本JADER数据库的恩曲替尼相关药品不良事件的发生时间分析  

Onset Time Analysis of Entrectinib-Induced Adverse Events Based on the U.S.FAERS Database and the Japanese JADER Database

作　　者：白荷荷[1] 聂晓静[1] 王金萍[1] 彭莉蓉[1] BAI Hehe;NIE Xiaojing;WANG Jinping;PENG Lirong(Dept.of Pharmacy,Xi’an Central Hospital,Xi’an 710000,China)

机构地区：[1]西安市中心医院药剂科,西安710000

出　　处：《中国医院用药评价与分析》2025年第4期488-493,共6页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：陕西省自然科学基金资助项目(No.2019JQ-984);西安市卫生健康委员会科研项目(No.2025ms05);陕西省药学会高质量发展项目(No.2024-1-1-3)。

摘　　要：目的:基于美国食品药品监督管理局不良事件报告系统(FAERS)数据库和日本药品不良事件报告系统(JADER)数据库,探讨恩曲替尼相关药品不良事件(ADE)的发生时间,为临床安全用药提供参考。方法:检索FAERS数据库(2019年第3季度至2024年第1季度)和JADER数据库(2019年第2季度至2024年第1季度)中恩曲替尼作为首要怀疑药物的ADE报告,采用国际医学用语词典中的首选术语对ADE进行标准化,采用世界卫生组织不良反应术语集中的系统器官分类(SOC)对ADE进行分类,利用报告比值比(ROR)法计算恩曲替尼相关ADE的信号强度,采用韦伯尔形状参数(WPS)检验分析ADE的发生时间。结果:在FAERS数据库和JADER数据库中均监测到各类神经系统疾病,心脏器官疾病,肾脏及泌尿系统疾病,呼吸系统、胸及纵膈疾病和肌肉骨骼系统疾病的信号;其中,肾脏及泌尿系统疾病信号最强,ROR(95%CI)分别为4.83(4.12~5.66)(FAERS数据库)、8.68(6.61~11.39)(JADER数据库);共有13个ADE未被恩曲替尼的药品说明书记载;恩曲替尼累及5类SOC的中位发生时间分别为14 d(FAERS数据库)、20 d(JADER数据库),大多数ADE发生于治疗后60 d内,各类神经系统疾病发生时间较早(约30 d内),肌肉骨骼系统疾病发生时间较晚(约90 d内);除JADER数据库中呼吸系统、胸及纵膈疾病的发生时间为随机衰竭型,其余均为早期衰竭型。结论:本研究探讨了恩曲替尼累及5类SOC的发生时间,提示用药前2周就应重视ADE的监测,尤其是存在上述系统合并症的患者。OBJECTIVE:To explore the onset time of entrectinib-induced adverse drug events(ADE)based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database and the Japanese Adverse Drug Event Report(JADER)database,so as to provide reference for clinical safety medication.METHODS:The FAERS database(from the third quarter of 2019 to the first quarter of 2024)and JADER database(from the second quarter of 2019 to the first quarter of 2024)were searched for reports of ADE with entrectinib as the primary suspected drug,the preferred terms in the International Dictionary of Medical Terms for regulatory activities were used to standardize ADE,the systemic organ classification(SOC)of the World Health Organization Adverse Reaction Terminology was used to classify ADE,the signal intensity of entrectinib-induced ADE was calculated by the reporting odds ratio(ROR)method,and the onset time of ADE in each system was analyzed by Weber’s shape parameter(WPS)test analysis.RESULTS:Positive signals were detected in both the FAERS and JADER databases for various neurological diseases,cardiac diseases,renal and urological diseases,respiratory chest and mediastinum diseases,and musculoskeletal diseases.Among them,kidney and urinary system disease signals were the strongest,with ROR(95%CI)of 4.83(4.12-5.66)in the FAERS database and 8.68(6.61-11.39)in the JADER database,respectively.A total of 13 ADE were not included in the drug instructions of entrectinib.The median onset time of entramitinib involved 5 types of SOC was respectively 14 d(FAERS database)and 20 d(JADER database).Most ADE occurred within 60 d after treatment,various neurological diseases occurred earlier(within about 30 d)and musculoskeletal system diseases later(within about 90 d).Except for the onset time of respiratory thoracic and mediastinal diseases in the JADER database was random failure type,the rest were early failure types.CONCLUSIONS:This study explore the onset time of ADE in 5 types of SOC induced by entrectinib,suggesting that the monit

关 键 词：恩曲替尼 药品不良事件 发生时间 自发报告系统 药物警戒 

分 类 号：R969.3[医药卫生—药理学] R979.1[医药卫生—药学]