首页|基于美国数据库的P2Y12受体拮抗剂不良事件信号检测与分析

基于美国数据库的P2Y12受体拮抗剂不良事件信号检测与分析

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目的 挖掘噻氯匹啶、氯吡格雷、普拉格雷和替格瑞洛4个P2Y12受体拮抗剂的不良事件(ADE)信号,为临床安全用药提供参考。方法 在美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)中提取4个P2Y12受体拮抗剂在2004年1月1日至2022年12月31日的报告数据,采用比例失衡法中的报告比值比(ROR)和贝叶斯置信度递进神经网络法(BCPNN)对所提取的数据进行挖掘与分析。结果 4个P2Y12受体拮抗剂共得到1 512个有效信号,其中噻氯匹啶101个,普拉格雷257个,氯吡格雷771个,替格瑞洛383个。ADE信号累及系统器官分类(SOC)22个。噻氯匹啶ADE信号数最多的SOC是血液及淋巴系统疾病,占28。71%;普拉格雷ADE信号数最多的SOC是心脏器官疾病,占18。36%;氯吡格雷ADE信号数最多的SOC是胃肠系统疾病,占23。75%;替格瑞洛ADE信号数最多的SOC是全身性疾病及给药部位各种反应,占22。86%。结论 经挖掘FAERS数据库,发现噻氯匹啶、氯吡格雷、普拉格雷和替格瑞洛4个P2Y12受体拮抗剂均存在ADE信号累及的SOC以及常见的不良事件,故临床需密切关注这些ADE,以避免出现其累及的SOC,防范风险事件发生。
Detection and analysis of P2Y12 receptor antagonists-related adverse event signals based on the FAERS database
Objective To explore the adverse drug events(ADE)signals of four P2Y12 receptor antago-nists(Ticlopidine,Clopidogrel,Prasugrel,and Ticagrelor)to provide reference for the safe clinical medication.Methods The ADE data of four P2Y12 receptor antagonists were collected from the FAERS database from Jan-uary 1,2004 to December 31,2022.The proportional report ratio(ROR)method and Bayesian confidence pro-gressive neural network(BCPNN)method within the proportional imbalance method were used to mine and ana-lyze the extracted data.Results A total of 1 512 valid signals were obtained for the four P2Y12 receptor antago-nists,including 101 signals for ticlopidine,257 signals for prasugrel,771 signals for clopidogrel,and 383 signals for ticagrelor.The ADE signals involve 22 different System Organ Class(SOC)categories.For ticlopidine,the SOC with the highest number of ADE signals was hematologic and lymphatic system diseases,accounting for 28.71%.For prasugrel,the SOC with the highest number of ADE signals was cardiac organ diseases,accounting for 18.36%.For clopidogrel,the SOC with the highest number of ADE signals was gastrointestinal system diseases,accounting for 23.75%.For ticagrelor,the SOC with the highest number of ADE signals was systemic diseases and various reactions at the administration site,accounting for 22.86%.Conclusions After mining the FAERS database,it was found that four P2Y12 receptor antagonists,namely ticlopidine,clopidogrel,pragrel and ticagrelor,all had ADE signal-involved SOCs and common adverse events.Therefore,clinical attention should be closely paid to these ADEs to avoid the occurrence of SOC involvement and prevent the occurrence of risk events.

Durg-related side effects and adverse reactionsSignal detectionFAERS databaseP2Y12 receptor antagonist

张舒宁、徐艳艳、骆松梅、汤文玲、叶淳

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浙江中医药大学药学院,浙江杭州 310000

丽水市中心医院药学部,浙江丽水 310000

药物相关性副作用和不良反应 信号检测 FAERS数据库 P2Y12受体拮抗剂

浙江省丽水市科技计划软科学研究计划

2022RKX29

2024

中国药物与临床
中国医院协会

中国药物与临床

影响因子:0.846
ISSN:1671-2560
年,卷(期):2024.24(7)