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基于美国FDA不良事件报告系统数据库的艾多沙班风险信号挖掘 被引量:6

Study on the risk signal mining related to edoxaban based on the US FDA Adverse Event Reporting System
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摘要 目的挖掘艾多沙班相关不良反应风险信号,为该药临床安全使用提供参考。方法检索美国FDA不良事件报告系统数据库,收集2011年第2季度至2022年第1季度以艾多沙班为怀疑药物的不良事件(AE)报告,采用报告比值比(ROR)法和比例报告比值比(PRR)法进行艾多沙班不良反应风险信号挖掘,报告数>3、ROR的95%CI下限>1和PRR>2且χ^(2)>4的AE定义为阳性信号。采用国际医学用语词典25.0版的首选术语(PT)和系统器官分类对AE进行分类统计,选取AE报告数和信号强度排名前50位的PT进行分析。结果共收集到艾多沙班为怀疑药物的AE报告4113例,涉及PT 996个。采用ROR法和PRR法进行计算,获得158个阳性PT信号,涉及AE报告1898例。以报告数和信号强度排名前50位的PT合并筛重后获得PT 89个,涉及AE报告1468例。报告数居前5位的PT依次为呼吸困难、贫血、房颤、黑便、心力衰竭;信号强度居前5位的PT依次为血管发育异常、泌尿生殖道出血、心脏淀粉样变性、舞蹈病、缺血性脑梗死/强心药水平升高。药品说明书中未收录的PT有45个,其中急性肾损伤、肾功能损害、间质性肺疾病等报告数较多、信号较强。结论出血相关事件仍为使用艾多沙班期间需重点监测的药物AE;艾多沙班还可能导致肾损伤和间质性肺疾病,需重点关注。 Objective To explore the risk signals of edoxaban-related adverse reactions and provide reference for the clinical safety of edoxaban.Method The US FDA adverse Event Reporting System database was searched and the adverse event(AE)reports on edoxaban as the suspicious drug from the second quarter of 2011 to the first quarter of 2022 were collected.An AE with reports>3,95%confidence interval(CI)lower limit of ROR>1,PRR>2,andχ^(2)>4 was defined as a positive signal.AEs were counted and classified using the preferred term(PT)and system organ class of Medical Dictionary for Regulatory Activities 25.0.The PTs of top 50 in AE report amount and signal intensity were selected and analyzed.Results A total of 4113 AE reports on edoxaban as the suspicious drug were collected and 996 PTs were involved.After calculation using ROR and PRR methods,158 positive risk signals were obtained,involving 1898 AE reports.PTs of the top 50 in AE report amount and signal intensity were merged 89 PTs were selected after screening out duplicates,involving 1468 AE reports.The top 5 PTs in report amount were dyspnea,anemia,atrial fibrillation,melena,and cardiac failure;the top 5 PTs in signal intensity were angiodysplasia,urogenital haemorrhage,cardiac amyloidosis,chorea,and ischaemic cerebral infarction/cardioactive drug level increased.Fourty-five PTs were not included in the drug labels.Of them,acute renal injury,renal impairment,and interstitial lung disease were with more AE reports and stronger signals.Conclusions Bleeding-related events are still the key AEs that need to be monitored during the use of edoxaban.Edoxaban may also lead to renal injury and interstitial lung disease,which requires special attention.
作者 王钰 李佳 潘韵妍 郑逸凡 陈攀 陈杰 Wang Yu;Li Jia;Pan Yunyan;Zheng Yifan;Chen Pan;Chen Jie(Department of Pharmacy,the First Affiliated Hospital,Sun Yat-sen University,Guangzhou 510080,China)
出处 《药物不良反应杂志》 CSCD 2022年第7期347-352,共6页 Adverse Drug Reactions Journal
基金 广东省临床用药研究基金(2020ZJ08)。
关键词 抗凝药 药物不良反应报告系统 美国食品药品管理局 信号处理 计算机辅助 艾多沙班 Anticoagulants Adverse drug reaction reporting systems United States Food and Drug Administration Signal processing,computer-assisted Edoxaban
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