基于FAERS的阿帕他胺相关实验室检查异常信号挖掘  

Data mining for abnormal adverse events signals related laboratory tests of Apalutamide based on FAERS

作　　者：王巧红 林拯 林木土 戴云 WANG Qiaohong;LIN Zheng;LIN Mutu;DAI Yun(Department of Pharmacy,Quanzhou Maternal and Child Health Care Hospital,Children's Hospital,Fujian Province,Quanzhou 362000,China;Department of Pharmacy,Quanzhou First Hospital,Fujian Province,Quanzhou 362000,China)

机构地区：[1]福建省泉州市妇幼保健院·儿童医院药剂科,福建泉州362000 [2]福建省泉州市第一医院药剂科,福建泉州362000

出　　处：《中国当代医药》2025年第2期4-7,共4页China Modern Medicine

摘　　要：目的通过对阿帕他胺的药物警戒信号进行挖掘分析,探讨该药物潜在的不良反应,为临床安全合理用药提供参考。方法检索美国食品药品监督管理局不良事件报告系统(FAERS)数据库中阿帕他胺的相关数据,采用报告比值比法(ROR)检测获得的药物警戒信号。结果共提取到6288例以阿帕他胺为首要怀疑药物的不良事件报告,共检测出255个警戒信号,涉及28个系统器官分类,主要发生在男性及年龄65岁以上的人群。实验室检查相关信号有19个,16个信号未被药品说明书收录。结论本研究共挖掘出有意义的阿帕他胺实验室检查药物警戒信号4个。临床使用阿帕他胺时,医生需要特别关注患者的血脂水平与心脏毒性,一旦出现不良反应,应及时处理并上报。Objective To explore the potential adverse reactions of Apalutamide by mining and analyzing the pharmacovigilance signals of Apalutamide,and to provide reference for clinical safe and rational drug use of apatamide.Methods The data of Apalutamide were retrieved from Food and Drug Administration Adverse Event Reporting System(FAERS)database,and the pharmacovigilance signals were detected by reporting odds ratio method(ROR).Results A total of 6288 cases of adverse drug events with Apalutamide as the primary suspected drug were extracted,and 255 warning signals were detected,involving 28 system and organ class.The reports mainly occurred in males and people over 65 years old.There were 19 signals related to laboratory tests,and 16 signals were not included in the drug instructions.Conclusion A total of four pharmacovigilance signals that are meaningful for laboratory examination of apaltamide were discovered.When using Apalutamide in clinical practice,the doctor need to pay more attention to the level of blood lipid and cardiac toxicity.Once adverse reactions occur,they should be treated and reported in time.

关 键 词：阿帕他胺 实验室检查 美国食品药品监督管理局不良事件报告系统 药品不良事件 报告比值比法 

分 类 号：R979.1[医药卫生—药品]