基于FAERS数据库对布地格福及氟替美维不良事件信号挖掘与分析  

Signal mining and analysis of adverse events of BUD/GLY/FOR and FF/UMEC/VI based on the FAERS database

作　　者：黄桂红 邓丽琳 林云 HUANG Guihong;DENG Lilin;LIN Yun(Office of Drug Clinical Trials Institution,the Second Affiliated Hospital of Guilin Medical University,Guangxi Zhuang Autonomous Region,Guilin 541199,China)

机构地区：[1]桂林医学院第二附属医院药物临床试验机构办公室,广西壮族自治区桂林市541199 [2]林医学院第二附属医院药学部,广西壮族自治区桂林市541199 [3]林医学院第二附属医院呼吸与危重症医学科,广西壮族自治区桂林市541199

出　　处：《临床合理用药》2025年第10期6-12,共7页Chinese Journal of Clinical Rational Drug Use

基　　金：广西壮族自治区卫生健康委员会药品临床综合评价项目(YPPJ017)。

摘　　要：目的分析布地格福与氟替美维的不良事件报告,为临床安全用药提供参考。方法基于美国食品药品监督管理局不良事件报告系统(FAERS)收集布地格福和氟替美维上市后的不良事件报告,利用报告比值比法(ROR)、比例报告比值法(PRR)、贝叶斯置信区间递进神经网络(BCPNN)及多变量伽马—泊松分布缩检法(MGPS)对药物不良事件报告进行信号检测。使用《国际医学用语词典》(MedDRA)(27.1版)对不良事件报告数据进行标准化描述和分类。结果分别检索到以布地格福和氟替美维为主要怀疑对象的不良事件报告18898份和43956份,主要的上报国家为美国,主要的上报人群为消费者,年龄主要分布在65~74岁,女性略多于男性,主要用于治疗慢性阻塞性肺疾病,给药途径多为吸入方式,且在用药后的0~30 d内发生不良事件的比例最高。2种药物的不良事件信号主要集中于“各类损伤、中毒及操作并发症”。咳嗽、发声困难、感染性肺炎、念珠菌感染、尿潴留等不良事件与药品说明书中的不良事件相吻合。此外,还分别发现布地格福和氟替美维17个和15个新的不良事件风险信号,其中死亡、呼吸困难及慢性阻塞性肺疾病是两者共有的新的不良事件风险信号。结论临床实践中必须重视患者是否正确使用这两种药物,特别是布地格福对患者的口手协调能力要求较高。同时应关注新的不良事件风险信号,对长期使用布地格福和氟替美维可能引发的感染和死亡风险应进行密切监测,以确保患者用药安全。Objective To analyze the adverse event reports of BUD/GLY/FOR and FF/UMEC/VI,and to provide reference for clinical safe drug use.Methods Based on the FAERS,the adverse event reports of BUD/GLY/FOR and FF/UMEC/VI after listing were collected,and the signal detection of adverse event reports was carried out by using the reporting odds ratio(ROR),proportional reporting ratio(PRR),bayesian confidence progressive neural network(BCPNN)and multi-item gamma-poisson shrinker(MGPS).The adverse event data were described and classified in a standardized manner using Medical Dictionary for Regulatory Activities(MedDRA,version 27.1).Results A total of 18898 and 43956 adverse event reports with BUD/GLY/FOR and FF/UMEC/VI as the main suspected objects were retrieved respectively.The main reporting country was the United States.The main reporting population was consumers,mainly aged 65-74 years old,slightly more women than men.They were mainly used for the treatment of COPD.The administration route was mostly inhalation,and the highest proportion of adverse events occurred within 0-30 days after medication.Adverse event signals for both drugs were mainly concentrated in"injuries,poisoning,and procedural complications".Adverse events such as cough,dysphonia,infectious pneumonia,candida infection,and urinary retention were consistent with those in the drug instructions.In addition,17 and 15 new adverse event risk signals were found for BUD/GLY/FOR and FF/UMEC/VI,respectively,of which death,dyspnea and COPD were the new adverse event risk signals shared by both.Conclusion Clinicians should ensure patients are using these medications correctly,particularly given the high level of oral coordination required for BUD/GLY/FOR.At the same time,attention should be paid to new adverse event risk signals,and close monitoring should be conducted for the risk of infections and death that may be caused by long-term use of BUD/GLY/FOR and FF/UMEC/VI to ensure the safe medication of patients.

关 键 词：布地格福 氟替美维 美国食品药品监督管理局不良事件报告系统 信号挖掘 感染 死亡 

分 类 号：R95[医药卫生—药学]