摘要
目的分析普拉格雷上市后药品不良事件(ADE)信号,为其临床安全合理用药提供依据。方法收集美国食品药品监督管理局公共数据开放项目(OpenFDA)数据库中普拉格雷上市后(2009年1月1日—2023年1月30日)的ADE报告,采用报告比数比法进行信号挖掘,根据《国际医学用语词典》将各信号映射得到其对应的系统器官分类(SOC),并与药品说明书做出对比与分析。结果共提取普拉格雷相关ADE报告10872例,挖掘到涉及11类SOC的44项有效信号,其中23项为未被药品说明书记录的潜在不良反应信号。结论目前可认为普拉格雷的安全性较好,但需密切关注和评估普拉格雷临床使用过程中患者发生胃肠系统疾病、血管假性动脉瘤、心脏器官疾病与肾脏泌尿系统不良事件的风险。
Objective To detect and analyze the adverse drug event(ADE)signals of prasugrel since its launch,and provide a basis for its clinical rational use.Methods ADE reports of prasugrel from January 1st,2009 to January 30th,2023 were collected from the OpenFDA database.The reporting odds ratio(ROR)method was used for signal detection.According to the Medical Dictionary for Regulatory Activities(MedDRA),each signal was mapped onto its corresponding system organ class(SOC),and compared and analyzed with adverse reactions in the prasugrel package insert.Results A total of 10872 ADE reports of prasugrel were extracted,in which 44 effective signals involving 11 types of SOC were detected.There were 23 potential adverse reaction signals that had been not recorded in the package insert.Conclusion At present,prasugrel was considered safe.However,it was necessary to pay close attention to and evaluate the risk of adverse events such as gastrointestinal disorders,vascular pseudoaneurysm,cardiac diseases,and renal and urinary disorders during the clinical use of prasugrel.
作者
侯梦雨
尹航
李江硕
张美娟
吴竞轩
董瑞华
Hou Meng-yu;Yin Hang;Li Jiang-shuo;Zhang Mei-juan;Wu Jing-xuan;Dong Rui-hua(Department of Research Ward,Beijing Friendship Hospital Affiliated to Capital Medical University,Beijing 100050,China)
出处
《中国药物应用与监测》
CAS
2024年第1期63-67,共5页
Chinese Journal of Drug Application and Monitoring
基金
中国毒理学会临床毒理专项(CST2020CT301)
北京市研究型病房建设示范单位项目(BCRW202010)。
