急性心肌梗死患者组织型纤溶酶原激活物的不良反应：真实世界和药物警戒数据库分析。

Adverse events of tissue plasminogen activators in acute myocardial infarction patients: a real-world and pharmacovigilance database analysis.

机构信息

Chongqing Key Laboratory of Emergency Medicine, Chongqing Emergency Medical Center/Chongqing University Central Hospital, School of Medicine, Chongqing University, Chongqing, 400014, China.

Department of Critical Care Medicine, Chongqing University Central Hospital, Chongqing, 400014, China.

出版信息

BMC Cardiovasc Disord. 2024 Aug 23;24(1):441. doi: 10.1186/s12872-024-04121-5.

DOI:10.1186/s12872-024-04121-5

PMID:39179962

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11342586/

Abstract

BACKGROUND

Tissue plasminogen activator (tPA) is recommended as the preferred thrombolytic therapy for acute myocardial infarction (AMI). This study aimed to explore tPA-related adverse events (AEs) reported in the United States Food and Drug Administration Adverse Event Reporting System (FAERS), assess the potential safety of three preferred tPA therapies for treating AMI, and provide guidance for selecting tPA for prehospital thrombolysis.

METHOD

Four algorithms, including ROR, PRR, BCPNN, and MGPS, were used to quantify the signals of Tenecteplase, Reteplase, and Alteplase related AEs and compare the differential degrees of the three tPA-associated AEs in the actual data.

RESULT

We detected 18 signals of Tenecteplase-induced AE, 29 signals of Reteplase-induced AE, and 22 signals of Alteplase-induced AE. Among the three drugs, Tenecteplase had the highest signal intensity for intracranial hemorrhage-related AE, followed by Alteplase. Besides, Reteplase had the highest signal intensity for procedure-related AE and Alteplase had the highest signal intensity for arrhythmia-related AE. The time-onset analysis indicates that we should be vigilant for AEs, especially within the first week and the first 1-2 days after medication.

CONCLUSION

This study identified and compared the signals of AE related to Tenecteplase, Reteplase, and Alteplase in AMI patients.

摘要

背景

组织型纤溶酶原激活剂（tPA）被推荐为急性心肌梗死（AMI）的首选溶栓治疗药物。本研究旨在探讨美国食品和药物管理局不良事件报告系统（FAERS）中报告的与 tPA 相关的不良事件（AE），评估三种治疗 AMI 的首选 tPA 疗法的潜在安全性，并为选择 tPA 进行院前溶栓治疗提供指导。

方法

使用 ROR、PRR、BCPNN 和 MGPS 四种算法对 Tenecteplase、Reteplase 和 Alteplase 相关 AE 的信号进行量化，并比较三种 tPA 相关 AE 在实际数据中的差异程度。

结果

我们检测到 18 个 Tenecteplase 诱导的 AE 信号、29 个 Reteplase 诱导的 AE 信号和 22 个 Alteplase 诱导的 AE 信号。在这三种药物中，Tenecteplase 引起的脑出血相关 AE 信号强度最高，其次是 Alteplase。此外，Reteplase 引起的与操作相关的 AE 信号强度最高，而 Alteplase 引起的心律失常相关 AE 信号强度最高。时间起始分析表明，我们应该警惕 AE，尤其是在用药后第一周和前 1-2 天。