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基于FAERS数据库分析病毒感染者使用A型肉毒毒素的不良事件OA

Analysis of adverse events in virus-infected patients using botulinum toxin type A based on the FAERS Database

中文摘要英文摘要

目的 通过挖掘美国食品药品监管局不良事件呈报系统(FAERS)数据库,探索病毒感染者使用A型肉毒毒素的潜在不良反应,为临床上针对病毒感染者安全使用该药提供依据.方法 提取FAERS数据库2004年第一季度到2025年第一季度共85个季度中相关报告,去除重复数据后使用MedDRA词典对数据进行校正.采用比例失衡法联合报告比值比(ROR)法、比例报告比值比(PRR)法、贝叶斯可信区间递进神经网络(BCPNN)法、多项式伽马泊松分布缩减(MGPS)法进行不良事件信号挖掘.结果 纳入病毒感染者420919例(不良事件1523172例次),其中使用A型肉毒毒素者74例(不良事件331例次).高信号强度的阳性信号的不良事件包括治疗应答缩短、面轻瘫、上睑下垂、产品制备错误、面痛等;高频阳性信号的不良事件包括超说明书使用、上睑下垂、治疗反应减弱、肌无力、治疗应答缩短等.结论 临床应用A型肉毒毒素时需要仔细询问患者病毒感染史,密切关注患者机体免疫状态,警惕患者用药后不良反应发生可能.

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.

赖圳登;王安兵;秦菲菲

深圳市龙岗区第六人民医院 整形外科,广东 深圳,518117||泰州苏王医疗美容门诊部,江苏 泰州,225300泰州苏王医疗美容门诊部,江苏 泰州,225300深圳市龙岗区第六人民医院 整形外科,广东 深圳,518117

FAERS数据库A型肉毒毒素病毒感染者不良事件

FAERS databaseBotulinum toxin type AVirus-infected patientsAdverse events

《中国医疗美容》 2026 (3)

51-56,6

10.19593/j.issn.2095-0721.2026.03.012

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