基于FAERS数据库的4种LAMA药物不良事件信号挖掘与分析  

Signal mining and analysis of adverse events of four LAMA drugs based on the FAERS database

作　　者：秦宏花 郭海嬿 杨柳 王莹 佟晓娜 李海峰 QIN Honghua;GUO Haiyan;YANG Liu;WANG Ying;TONG Xiaona;LI Haifeng(School of Pharmacy,Dali University,Dali 671000,Yunnan Province,China;Department of Pharmacy,the Third People’s Hospital of Yunnan Province,Kunming 650011,China)

机构地区：[1]大理大学药学院,云南大理671000 [2]云南省第三人民医院药剂科,昆明650011

出　　处：《药物流行病学杂志》2024年第10期1081-1090,共10页Chinese Journal of Pharmacoepidemiology

基　　金：国家自然科学基金地区科学基金项目(81860017)。

摘　　要：目的挖掘与分析阿地溴铵、格隆溴铵、乌美溴铵、噻托溴铵4种长效抗胆碱能药物(LAMA)上市后的不良事件(ADE)信号,为临床安全用药提供参考。方法检索美国食品药品管理局不良事件报告系统2004年第1季度到2024年第1季度数据,将阿地溴铵、格隆溴铵、乌美溴铵、噻托溴铵进行药名标准化后以“主要怀疑药物”作为限制条件,获得与其有关的ADE记录。采用报告比值比(ROR)法、综合标准(MHRA)法和贝叶斯置信区间递进神经网络(BCPNN)法挖掘潜在的ADE信号,并通过《国际医学用语词典》26.1版对ADE信号挖掘结果进行系统分类。结果共收集到80680份与4种LAMA药物有关的ADE报告,其中阿地溴铵4287份、格隆溴铵3584份、乌美溴铵3084份、噻托溴铵69725份;ADR报告涉及患者中,女性(47725例,59.15%)多于男性(27525例,34.11%)。上报国家主要是美国,报告者多为消费者、药师、医师;ADE报告的严重结局涉及危及生命、住院、残疾、死亡等。共挖掘到902个信号,涉及27个系统/器官分类,其中阿地溴铵、格隆溴铵、乌美溴铵、噻托溴铵的信号数分别为180、210、142、370。4种LAMA药物ADE信号主要集中在呼吸系统、胸及纵膈疾病,各类检查,各类损伤、中毒及操作并发症,眼器官疾病,胃肠系统疾病等方面。结论临床使用LAMA药物治疗呼吸系统疾病时应做好相关预防措施,监测是否出现呼吸系统、胸及纵膈疾病,眼器官变化及实验室各类检查指标等,减少用药风险。Objective To investigate and assess the risk signals of adverse drug events(ADEs)associated with the post-marketing 4 long-acting anticholinergic antagonists(LAMA),including adionium bromide,glycopyrronium bromide,umeonium bromide,and tiotropium bromide,to provide references for clinically safe prescribing practices.Methods Four LAMA drugs-related ADE records were selected by searching the FAERS database from the first quarter of 2004 to the first quarter of 2024 and standardizing the drug name of adionium bromide,glycopyrronium bromide,umeonium bromide,and tiotropium bromide,with the primary suspected drug as a restriction.Potential ADE signals were mined using the reporting odds ratio(ROR)method,medicines and healthcare products regulatory agency(MHRA)method and Bayesian confidence propagation neural network(BCPNN)method,and Medical Dictionary for Drug Regulatory Activities 26.1 was used to classify the results systematically.Results A total of 80680 reports of four LAMA drugs-related ADE were collected,including 4287 reports for aclidinium bromide,3584 reports for glycopyrronium bromide,3084 reports for umeclidinium bromide and 69725 reports for iotropium bromide.The reports predominantly involved female patients(47725 cases,59.15%)over male patients(27525 cases,34.11%).The United States emerged as the principal reporting country,with consumers,pharmacists,and physicians as the primary reporters.Serious ADE outcomes included life-threatening conditions,hospitalizations,disabilities,deaths.A total of 902 signals were identified,mainly affecting 27 systems or organs.Specifically,aclidinium bromide(180 signals),glycopyrronium bromide(210 signals),umeclidinium bromide(142 signals),and tiotropium bromide(370 signals)exhibited signals predominantly in the respiratory,thoracic and mediastinal disorders,investigations,injury,poisoning and procedural complications,eye and organ diseases cgastrointestinal disorders.Conclusion When using LAMA drugs for respiratory conditions,clinicians should implement preventive measure

关 键 词：阿地溴铵 格隆溴铵 乌美溴铵 噻托溴铵 药品不良事件 信号挖掘 药物警戒 FAERS数据库 

分 类 号：R969[医药卫生—药理学]