低剂量阿司匹林与产后静脉血栓栓塞的安慰剂:一个多国,试点,随机,安慰剂控制的试验
Leslie Skeith1, A Kinga Malinowski2, Darine El-Chaâr3
1Division of Hematology and Hematological Malignancies, Department of Medicine, University of Calgary, Calgary, AB, Canada.
The Lancet. Haematology
|January 19, 2025
概括
在高危人群中研究低剂量阿司匹林用于产后血栓预防的全球试验是可行的. 该研究表明,进行这样的试验是可能的,也是必要的,以产生有关静脉血栓栓塞预防的高质量数据.
科学领域:
- 产科和妇科 产科和妇科
- 心血管医学 心血管医学
- 临床试验方法论 临床试验方法论
背景情况:
- 静脉血栓塞栓症 (VTE) 具有显著的产后风险,但对中度风险患者的血栓预防的证据是有限的.
- 评估随机对照试验 (RCT) 的可行性对于产后VTE预防至关重要.
研究的目的:
- 评估一项低剂量阿司匹林用于产后血栓预防的双盲,安慰剂控制试验的可行性.
- 为了确定阿司匹林在产后患有VTE风险因素的个体中的招募率和安全性.
主要方法:
- 试点PARTUM试验是一项多国,随机,双盲,安慰剂控制的研究.
- 符合条件的参与者每天接受低剂量阿司匹林或安慰剂,分娩后42天.
- 主要可行性结果是每个地点每月的平均招聘率.
主要成果:
- 该研究实现了平均每月每站点6.3名患者的招募率.
- 在低剂量阿司匹林组中没有发生静脉动脉突发事件;在安慰剂组中发生了一例远部深静脉血栓症.
- 没有报告重大出血事件;临床相关的非重大出血是罕见的,并且在不同组之间相似.
结论:
- 评估低剂量阿司匹林用于产后血栓预防的全球试验是可行和合理的.
- 这些发现支持需要进行更大规模的试验,以提供高质量的关于产后个体VTE预防的数据.
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