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 17 307 472 reports were enrolled in the study,and 2 387 reports with tirofiban as the primary suspected drug were collected,with the reporters mainly from China(1 221 cases,51.15％).The identity of the reporters was mainly physicians(1 466 cases,61.42％).A total of 2 444 cases of indications were involved,mainly were antiplatelet therapy(1 428 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 respiratoryfailure,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
Key words
Tirofiban/Adverse drug event/Pharmacovigilance/Proportional imbalance method/U.S.Food and Drug Administration Adverse Event Reporting System
维普
万方数据