Mining of adverse reaction signal of aflibercept intraocular injection based on FDA adverse event reporting system database
Objective To explore the extraction adverse drug reaction(ADR)signals of aflibercept intravenous injection,using the FDA adverse event reporting system(FAERS)database,and provide a reference for the safe and rational medication.Methods The reporting odds ratio(ROR),proportional reporting ratio(PRR)and Bayesian confidence propagation neural network(BCPNN)were used to detect the adverse drug events(ADEs)of aflibercept intravenous injection from the first quarter of 2004 to the third quarter of 2020 in the FAERS.Results Among 10 500 309 ADE reports retrieved related to aflibercept in-travenous injection,including 15 658 ADE reports after filter and duplication.A total of 429 ADR signals were detected,in-cluding ocular organ diseases,systemic diseases and reactions at the administration site,various injuries,poisoning and opera-tional complications,various neurological diseases,various surgical and medical procedures,infectious diseases,ear and lab-yrinth diseases.The top 5 ADR signals by frequency were noninfectious endophthalmitis,endophthalmitis,vitrectomy,vitre-ous inflammation,and transient blindness.Meanwhile,suspicious ADR signals such as dementia,hypoacusis,and sudden hearing loss,which not been mentioned in the drug labels,were also detected.Conclusion This study suggests that we should pay more attention to the ADR of aflibercept intravenous injection mentioned in the drug instructions and literature,and strengthen pharmaceutical care.Further research should be conducted on the unreported suspicious ADR signals discovered in this study.In addition,the use of aflibercept intravenous injection requires high operation proficiency of ophthalmologist,and relevant training should be done.
intravitreal afliberceptFDA adverse event reporting system databaseadverse drug eventsadverse reaction signaldata mining
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