用重组激活因子VII治疗的严重产后出血中的血栓栓塞事件:系统性文献综述和元分析
Johanna G van der Bom1, Frédéric J Mercier2, Damaris Bausch-Fluck3
1Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.
Research and practice in thrombosis and haemostasis
|September 12, 2024
概括
这次审查发现,与未接受治疗的女性相比,在接受复合激活因子VII (rFVIIa) 治疗产后出血 (PPH) 的女性中,发生血栓栓塞事件 (TEs) 的比例相似,较低. 需要更多的研究才能充分理解PPH管理中的RFVIIa安全性.
科学领域:
- 产科和妇科 产科和妇科
- 血液学 血液学 血液学
- 临床药理学 临床药理学
背景情况:
- 产后出血 (PPH) 是孕产妇发病的一个重要原因.
- 重组激活因子VII (rFVIIa) 是当子宫激素无效时,严重的PPH的治疗选择.
- 对PPH的rFVIIa进行的大型试验的可靠安全数据有限.
研究的目的:
- 系统地审查和分析患有PPH的女性中血栓栓塞事件 (TE) 的发生率.
- 为了比较接受rFVIIa治疗的女性和不接受rFVIIa治疗PPH的女性的试验体验.
主要方法:
- 对同行评审出版物和会议摘要的系统审查 (1996-2022年).
- 包括研究报告的TEs在妇女的PPH,治疗或不用rFVIIa治疗.
- 使用通用线性混合模型估计TE比例的元分析.
主要成果:
- 包括55篇出版物,分析了611名接受rFVIIa治疗的妇女和32,488名未接受治疗的妇女的数据.
- 在rFVIIa治疗组中,预计TEs的比例为1.82%,在未治疗组中为0.72%.
- 估计的TE比例很小,并且表现出广泛的,重叠的预测间隔.
结论:
- 在患有严重PPH的妇女中,TEs的发病率似乎同样低,无论她们是否接受了rFVIIa治疗.
- 目前的数据表明,TEs的风险概况相似,但由于预测间隔很长,存在相当大的不确定性.
- 需要进一步进行精心设计的临床试验,以最终评估rFVIIa在PPH管理中的安全性.
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