在使用复合人凝血因子VIIa后发生的血栓栓塞性不良事件
Kathryn A O'Connell1, Jennifer J Wood, Robert P Wise
1Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Md 20852-1448, USA. oconnellk@cber.fda.gov
JAMA
|January 19, 2006
概括
与复合人体凝血因子VIIa (rFVIIa) 报告了严重的血栓栓塞事件,特别是在没有血友病的患者中. 需要进一步的随机试验来确认这些人群的安全性和有效性.
科学领域:
- 药物监督 药物监督 药物监督
- 血液学 血液学 血液学
- 血栓形成的原因之一是血栓形成.
背景情况:
- 重组人凝血因子VIIa (rFVIIa) 于1999年被FDA批准用于服用抑制剂的血友病患者.
- 自从获得许可以来,rFVIIa的非标签使用量有所增加.
研究的目的:
- 审查与rFVIIa相关的严重血栓栓塞不良事件 (AEs),报告给FDA的不良事件报告系统 (AERS).
主要方法:
- 1999年3月至2004年12月对AERS数据库的审查发现了与rFVIIa相关的血栓栓塞性AE.
- 包括批准和未标记用途的自发报告,以及许可证后试验中的严重副作用.
主要成果:
- 在431份rFVIIaAE报告中报告了185起血栓栓塞事件.
- 大多数事件 (151) 发生在未标记的指示下,经常发生在活跃出血的患者中.
- 脑血管事故,心肌梗塞和肺/静脉血栓是常见的副作用,报告中的72%的死亡归因于这些事件.
结论:
- 血栓塞栓性副作用,通常是严重的,与rFVIIa有关,特别是未标记的用途.
- 混杂因素,如同时服用的药物和先前存在的疾病,限制了最终的安全性分析.
- 随机对照试验对于确定rFVIIa在非血友病患者中的安全性和有效性至关重要.
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