| 摘要: |
| 目的 基于美国FDA不良事件报告系统（FDA Adverse Event Reporting System，FAERS）数据库，挖掘与分析抗血小板类药物支架内血栓形成不良事件（adverse drug event，ADE）报告，为其临床安全合理用药提供参考。方法 利用OpenVigil 2.1数据平台分析工具，提取从2003年10月1日至2024年12月31日期间与支架内血栓形成事件相关的不良事件报告记录，通过报告比值比法（Reporting odds ratio，ROR）和比例报告比值法（Proportional reporting ratio，PRR）对抗血小板类药物的支架内血栓形成不良事件报告数据进行风险信号挖掘和分析。结果 共检索到以抗血小板类药物为首要怀疑药品的支架内血栓形成不良事件939份，男性549例（58.47%），女性167例（17.78%），男女比例为3.29，不详223例。患者发生ADE的年龄主要集中在40-64岁和65-85岁之间，以美国上报例数最多。其中报告前五位的分别是替格瑞洛426例（45.37%）、氯吡格雷291例（31.00%）、普拉格雷91例（9.70%）、阿司匹林62例（6.60%）和替罗非班47例（5.00%），在支架内血栓形成不良事件上共生成7个可疑信号。结论 抗血小板类药物可能增加支架内血栓形成的风险，目前可认为阿司匹林的安全性较好，而P2Y12受体抑制不全是影响支架内血栓形成的危险因素，临床中还需要进一步的研究来证实我们的发现。 |
| 关键词: 抗血小板类药物 不良反应 支架内血栓形成 信号挖掘 |
| DOI： |
| 分类号: |
| 基金项目:嘉兴市科技计划项目 |
|
| Risk Analysis of Stent Thrombosis Adverse Events Associated with Antiplatelet Drugs Based on the FDA Adverse Event Reporting System (FAERS) Database |
|
chenqianqian, feiaili, zhaoliping, zhangbin
|
|
the Second Hospital of Jiaxing
|
| Abstract: |
| ObjectiveBased on the FDA Adverse Event Reporting System (FAERS) database, this study aims to mine and analyze adverse drug event (ADE) reports related to stent thrombosis caused by antiplatelet drugs, providing a reference for their safe and rational clinical use. Methods Using the OpenVigil 2.1 data platform, adverse event report records associated with stent thrombosis were extracted from October 1, 2003, to December 31, 2024. The Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) methods were employed to identify and analyze risk signals in the adverse event reports of stent thrombosis induced by antiplatelet drugs. Results A total of 939 adverse event reports involving stent thrombosis with antiplatelet drugs as the primary suspected medications were retrieved. Among these, 549 cases (58.47%) were male, 167 cases (17.78%) were female, yielding a male-to-female ratio of 3.29. Gender information was unavailable for 223 cases (23.75%). The age distribution of patients experiencing ADEs primarily concentrated in the 40–64 years and 65–85 years age groups. The majority of reports originated from the United States. The top five drugs associated with stent thrombosis were ticagrelor (426 cases, 45.37%), clopidogrel (291 cases, 31.00%), prasugrel (91 cases, 9.70%), aspirin (62 cases, 6.60%), and tirofiban (47 cases, 5.00%). Seven suspected risk signals for stent thrombosis were identified. Conclusion Antiplatelet drugs may increase the risk of stent thrombosis. Aspirin appears to exhibit relatively better safety compared to other drugs in this class. Incomplete inhibition of the P2Y12 receptor is a potential risk factor contributing to stent thrombosis. Further clinical studies are warranted to validate these findings. |
| Key words: antiplatelet drugs adverse reaction stent thrombosis signal mining |