基于美国FAERS数据库的替罗非班相关药品不良事件信号挖掘与分析  

Signal Mining and Analysis of Tirofiban-Related Adverse Drug Event Based on the U.S.FAERS Database

作　　者：梁皓楠 李中华[1] 王巧云[2] 李祥鹏[2] LIANG Haonan;LI Zhonghua;WANG Qiaoyun;LI Xiangpeng(Dept.of Pharmacy,Rongcheng People’s Hospital,Shandong Rongcheng 264300,China;Dept.of Pharmacy,Affiliated Hospital of Qingdao University,Shandong Qingdao 266003,China)

机构地区：[1]荣成市人民医院药剂科,山东荣成264300 [2]青岛大学附属医院药学部,山东青岛266003

出　　处：《中国医院用药评价与分析》2024年第8期1016-1019,1024,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家卫生健康委医院管理研究所医院药学高质量发展研究项目(No.NIHAYS2308);中国健康促进基金会项目(No.GL-C012)。

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,对替罗非班相关药品不良事件(ADE)信号进行挖掘,为临床合理用药提供参考。方法:利用报告比值比(ROR)法以及英国药品和保健产品管理局(MHRA)的综合标准法,对美国FAERS数据库中2004年第1季度至2023年第4季度上报的替罗非班相关ADE信号进行挖掘。结果:纳入研究的报告共17 307 472份,收集到以替罗非班为主要怀疑药物的报告共2 387份,报告者主要来自中国(1 221份,占51.15%);报告者身份主要为医师(1 466份,占61.42%);涉及适应证共2 444例次,主要为抗血小板治疗(1 428例次,占58.43%);挖掘出有效信号111个,包括出血、血小板减少症、心肌梗死等;涉及13个系统器官分类,主要为心脏器官疾病、血管与淋巴管类疾病、各类神经系统疾病等;发现心源性休克、心室颤动、急性肺水肿、急性呼吸衰竭、肌钙蛋白T升高、心源性死亡、黏膜出血等药品说明书中未提及的ADE信号。结论:通过对美国FAERS数据库中替罗非班相关ADE信号的挖掘分析,提示临床使用该药时除了要关注出血等相关不良反应外,对心血管系统以及呼吸系统的一些药品说明书中未提及的新的潜在不良反应信号也需要多加关注。OBJECTIVE:To analyze and mine tirofiban-related adverse drug event(ADE)signals based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,so as to provide references for clinical rational medication.METHODS:Tirofiban-related ADE signals reported in the U.S.FAERS database from the first quarter of 2004 to the fourth quarter of 2023 were mined by using the reporting odds ratio(ROR)method and the comprehensive standard method of U.K.Medicines and Healthcare Products Regulatory Agency(MHRA).RESULTS:A total of 17307472 reports were enrolled in the study,and 2387 reports with tirofiban as the primary suspected drug were collected,with the reporters mainly from China(1221 cases,51.15%).The identity of the reporters was mainly physicians(1466 cases,61.42%).A total of 2444 cases of indications were involved,mainly were antiplatelet therapy(1428 cases,58.43%);111 valid signals were unearthed,including hemorrhage,thrombocytopenia,myocardial infarction;13 system/organ classifications were involved,mainly were cardiac organ diseases,vascular and lymphatic vessel diseases,and various types of nervous system disease.ADE signals not mentioned in the drug instructions such as cardiogenic shock,ventricular fibrillation,acute pulmonary edema,acute respiratory failure,elevated troponin T,cardiac death,mucosal haemorrhage were detected.CONCLUSIONS:The mining and analysis of tirofiban-related ADE signals through the U.S.FAERS database suggests that,in addition to bleeding and other ADE,new potential ADE signals in the cardiovascular and respiratory systems that are not mentioned in the drug instructions also need to be paid attention.

关 键 词：替罗非班 药品不良事件 药物警戒 比例失衡法 美国食品药品监督管理局不良事件报告系统 

分 类 号：R973.2[医药卫生—药品]