基于FAERS数据库的西洛他唑安全信号挖掘OA

Objective To explore the signal of cilostazol adverse events,and to provide the basis for clinical rational drug use.Methods The adverse drug events(ADE)of cilostazol from January 2004 to June 2024 were collected from the US Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database.The ADE were standardized using the latest MedDRA27.0 system organ classification(SOC)and preferred term(PT)and the Risk Signal Mining of ADE was conducted by using the report ratio method(ROR),the proportion report ratio method(PRR),and the Bayesian credible interval incremental neural network(BCPNN)method.Results A total of 307 positive signals were obtained by ROR,PRR and BCPNN combined analysis,involving 24 SOCs such as heart organ diseases,various nervous system diseases,various examinations and gastrointestinal system diseases.The top 10 PTs in terms of reporting numbers were anemia,heart failure,deterioration,palpitations,cerebral infarction,tachycardia,loss of consciousness,atrial fibrillation,cerebral hemorrhage,and hypotension,all of which were ADE listed in the drug's package insert.The top 10 PTs for signal strength were cardiac venous perforation,basal ganglia hematoma,coronary artery bypass grafting,cerebral hyperperfusion syndrome,arterial restenosis,thromboangiitis obliterans,thalamic hemorrhage,aortic dissection,paroxysmal tachycardia,and cerebral thromboembolism,all of which were serious ADE.Conclusion The serious ADE of cilostazol in the cardiovascular and nervous systems should be closely monitored,and clinicians should be vigilant.