在手术后预防慢性皮下血瘤复发的脑膜栓塞:EMPROTECT随机临床试验
Eimad Shotar1,2, Bertrand Mathon3,4, Henri Salle5
1APHP, Department of Neuroradiology, Pitié-Salpêtrière Hospital, Paris, France.
JAMA
|June 5, 2025
概括
中脑膜动脉 (MMA) 栓塞并没有显著减少手术后慢性腹腔内血瘤 (CSH) 的复发. 进一步的研究可能会澄清MMA栓塞
科学领域:
- 神经外科和干预性神经放射学
- 血管干预
- 神经外科手术
背景情况:
- 慢性皮下血瘤 (CSH) 是一个重要的临床挑战,手术后的复发构成风险.
- 中脑膜动脉 (MMA) 栓塞已经成为减少CSH复发的潜在辅助疗法.
研究的目的:
- 评估MMA栓塞在手术患者中降低CSH6个月复发率的有效性.
- 在高危CSH患者中,将MMA栓塞加标准治疗与单独标准治疗进行比较.
主要方法:
- 一个多中心的,开放的,随机的临床试验,涉及342名CSH复发高风险的患者.
- 参与者被随机分配到手术或标准医疗护理后7天内使用微粒进行MMA栓塞.
- 主要结果是6个月后的CSH复发,由一个盲目的评判委员会进行评估.
主要成果:
- 在MMA栓塞组,6个月后CSH复发率为14. 8%,在标准治疗组为21. 0% (P=13).
- 对于二次终点,包括重复手术的发生率,没有观察到显著的群体差异.
- 与栓塞手术相关的并发症很少 (1. 8% 是轻微的, 0. 6% 是严重的).
结论:
- 与本试验中的标准治疗相比,MMA栓塞并没有显著降低6个月后的CSH复发率.
- 观察到的效果大小与其他试验一致,表明需要进一步调查的潜在效用.
- 结果可能会为未来的MMA栓塞研究提供信息,特别是使用不同的栓塞剂.
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