摘要
Abstract
Objective To investigate the potential adverse reactions associated with the use of botulinum toxin type A in patients with viral infections by mining the FDA Adverse Event Reporting System(FAERS)database,thereby providing evidence to support the safe clinical use of this drug in this patient population.Methods Data spanning 85 quarters from Q1 2004 to Q1 2025 were extracted from the FAERS database.After removing duplicate reports,data were standardized using the MedDRA terminology.Signal detection for adverse events was performed using the disproportionality analysis methods,including the Reporting Odds Ratio(ROR),Proportional Reporting Ratio(PRR),Bayesian Confidence Propagation Neural Network(BCPNN),and Multi-item Gamma Poisson Shrinker(MGPS)algorithms.Results A total of 420,919 patients with viral infections(involving 1,523,172 adverse event instances)were included,among which 74 patients had used botulinum toxin type A(331 adverse event instances).Adverse events with high signal strength included shortened therapeutic response,facial paresis,eyelid ptosis,product preparation error,and facial pain.Frequently reported positive signals involved off-label use,eyelid ptosis,decreased therapeutic response,muscle weakness,and shortened therapeutic response.Conclusion When administering botulinum toxin type A in clinical practice,it is essential to thoroughly inquire about patients'history of viral infections,closely monitor their immune status,and remain vigilant for potential adverse reactions following drug administration.关键词
FAERS数据库/A型肉毒毒素/病毒感染者/不良事件Key words
FAERS database/Botulinum toxin type A/Virus-infected patients/Adverse events
