使用JAK抑制剂调查深静脉血栓的风险:使用FDA不良事件报告系统数据库 (FAERS) 进行不成比例分析
Shefin Mytheen1, Anju Varghese1, Jismol Joy1
1Nirmala College of Pharmacy, Kerala University of Health Sciences, Thrissur, India.
Expert opinion on drug safety
|June 9, 2023
概括
雅努斯激酶 (JAK) 抑制剂,如巴里西提尼布,托法西提尼布和乌帕达西提尼布,显示了深静脉血栓 (DVT) 的安全信号. 这些风险在老年人和男性中更高,需要进一步调查.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 免疫学 免疫学 免疫学
背景情况:
- 简氏激酶 (JAK) 抑制剂是一种免疫调节药物,用于各种炎症和骨髓增殖性疾病.
- 这些药物与深静脉血栓形成 (DVT) 的风险增加有关.
研究的目的:
- 调查与JAK抑制剂相关的DVT的潜在安全信号.
- 使用FDA不良事件报告系统 (FAERS) 数据库的不成比例分析.
主要方法:
- 追溯案例/非案例分析从2004Q1到2022Q4.
- 包括JAK抑制剂:巴里西提尼布,托法西提尼布和上达西提尼布.
- 分析了首选术语"深静脉血栓症",使用报告几率比率,比例报告比率和信息组件.
主要成果:
- 在114,005份JAK抑制剂不良事件报告中,确定了647份DVT报告.
- 巴里西丁尼和托法西丁尼在65-100岁的个体中显示出更强烈的DVT信号.
- 在男性中,这三种JAK抑制剂都显示出对DVT的信号强度最高.
结论:
- 这项研究检测出了巴里西提尼布,托法西提尼布和乌帕达西提尼布对DVT的安全信号.
- 为了证实这些发现,需要使用可靠的流行病学数据进行进一步的研究.
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