三种静脉用溶栓药物在真实世界的不良反应药物警戒研究

A pharmacovigilance study of adverse effects of three intravenous thrombolytic drugs in the real world

关键词:  注射用溶栓药  ROR法  MHRA法  FAERS数据库  不良事件信号挖掘

Key words:  thrombolytic drugs for injection  ROR method  MHRA method  FAERS database  adverse event signal mining

摘要:

摘要：目的 本研究根据FDA不良事件上报（FAERS）数据库中注射用溶栓药物阿替普酶，替奈普酶和瑞替普酶的药物不良反应数据，通过数据挖掘，为临床合理用药提供指导，并优化患者治疗方案。方法 本研究在 Openvigil 药物警戒数据分析网站使用 OpenVigil 2.1-MedDRA-v26.1(data 2004Q1-2023Q3)在线分析系统，对美国 FDA 不良事件报告系统 2004年第1季度—2023第3季度的数据进行分析：提取首选语 PT 为“alteplase”，“tenecteplase”，“reteplase”的数据。然后采用了报告比值法（ROR），综合标准法（MHRA）来进行阿替普酶，替奈普酶和瑞替普酶不良反应报告的数据挖掘。我们使用MedDRA术语集对阳性信号进行汉化和系统分类。结果 阿替普酶和替奈普酶均出现感染性肺炎和骨筋膜室综合征的新信号，并且阿替普酶出现血管性水肿的强信号，瑞替普酶出现马-魏二氏综合征的强信号。结论 三种溶栓药物均有新的不良反应信号，医务人员在进行溶栓治疗时，除关注各部位出血等药品说明书中已有的不良事件外，还应密切关注说明书中未收录但信号值较强的不良事件，保证患者用药的安全性和有效性。

Abstract:

ABSTRACT: OBJECTIVE This study utilizes adverse event data of intravenous thrombolytic agents—Alteplase, Tenecteplase, and Reteplase—from the FDA Adverse Event Reporting System (FAERS) database. Through data mining, it aims to offer guidance for clinical rational drug use and optimize patient treatment plans. METHODS This study utilized the OpenVigil 2.1-MedDRA-v26.1 (data from 2004Q1 to 2023Q3) online analysis system on the Openvigil drug surveillance data analysis website to analyze data from the U.S. FDA Adverse Event Reporting System for the first quarter of 2004 through the third quarter of 2023. The analysis involved extracting data related to Preferred Terms (PT) with the names "alteplase," "tenecteplase," and "reteplase." Afterwards, the Reporting Odds Ratio (ROR) and Medicines and Healthcare products Regulatory Agency (MHRA) methods were employed to conduct data mining on adverse reaction reports associated with alteplase, tenecteplase, and reteplase. We utilized the MedDRA terminology set for the translation and systematic classification of positive signals. RESULTS Both Alteplase and Tenecteplase exhibited new signals for i[1]nfectious pneumonia and compartment syndrome, while Alteplase demonstrated a strong signal for vascular edema, and Reteplase displayed a strong signal for Marfan syndrome.CONCLUSION All three thrombolytic drugs present new adverse event signals. Medical practitioners administering thrombolytic therapy should not only focus on known adverse events such as bleeding in various sites, as indicated in the drug's manual, but also closely monitor adverse events with strong signals that are not documented in the manual. This ensures the safety and efficacy of patient medication.