在类风湿性关节炎患者中与托法西提尼布相关的静脉血栓栓塞事件:来自FAERS数据库的现实研究
Jintuo Zhou1, Ruihong Cai1, Peiguang Niu1
1Department of Pharmacy, Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, #18 Daoshan Road, Fuzhou, China.
Naunyn-Schmiedeberg's archives of pharmacology
|October 11, 2025
概括
与TNF抑制剂相比,在类风湿性关节炎患者中使用托法西替尼与静脉血栓栓塞 (VTE) 的风险更高,包括肺栓塞和深静脉血栓症. 在处方这种JAK抑制剂时,仔细的患者选择和风险评估至关重要.
科学领域:
- 药物监督 药物监督 药物监督
- 类风湿病学 类风湿病学
- 心血管安全心血管安全
背景情况:
- 托法西提尼布是一种口服的Janus激酶 (JAK) 抑制剂,用于治疗类风湿性关节炎 (RA).
- 在RA患者中使用托法西提尼布的静脉血栓塞栓症 (VTE) 风险需要进一步调查.
- 将托法西替尼的VTE风险与瘤亡因子抑制剂 (TNFi) 的风险进行比较,对于临床决策很重要.
研究的目的:
- 评估托法西提尼布使用与 RA 患者的 VTE 风险之间的关联.
- 为了比较tofacitinib与TNFi的VTE报告几率比率 (ROR).
- 为了确定与tofacitinib相关的特定VTE事件类型 (PE,DVT).
主要方法:
- 使用FDA不良事件报告系统 (FAERS) 数据 (2012年第一季度 - 2024年第四季度) 的回顾性药监测研究.
- 使用报告几率比率 (ROR) 来比较VTE报告风险的不成比例分析.
- 分析与RA相关的不良事件报告,重点关注托法西替尼和TNFi.
主要成果:
- 与一般的FAERS数据库 (ROR 1.56) 相比,托法西替尼显示VTE的风险明显增加.
- 与TNFi相比,托法西替尼与VTE的ROR较高相关 (ROR 2.20).
- 肺栓塞 (PE) (ROR 1.90) 和深静脉血栓塞 (DVT) (ROR 1.36) 的风险增加.
结论:
- 与TNFi相比,在RA患者中使用托法西提尼布与报告VTE事件的风险更高有关.
- 这些发现突显出需要对tofacitinib进行仔细的患者选择和风险评估.
- 需要进一步的前性研究来证实这些关联并阐明潜在的机制.
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