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Efficacy of prothrombin complex concentrates for the emergency reversal of dabigatran-induced anticoagulation

机译:凝血酶原复合物浓缩物对达比加群诱导的抗凝作用的紧急逆转的功效

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摘要

Dabigatran is effective in decreasing the risk of ischaemic stroke in patients with atrial fibrillation. However, like all anticoagulants, it is associated with a risk of bleeding. In cases of trauma or emergency surgery, emergency reversal of dabigatran-induced anticoagulation may be required. A specific reversal agent for dabigatran, idarucizumab, has been approved by the US Food and Drug Administration. Alternative reversal agents are available, such as prothrombin complex concentrates (PCCs) and activated PCCs (aPCCs). In this review we evaluate the role of PCCs and aPCCs in the reversal of dabigatran anticoagulation and consider which tests are appropriate for monitoring coagulation in this setting. Pre-clinical studies, small clinical studies and case reports indicate that PCCs and aPCCs may be able to reverse dabigatran-induced anticoagulation in a dose-dependent manner. However, dosing based on coagulation parameters can be difficult because available assays may not provide adequate sensitivity and specificity for measuring anticoagulation induced by dabigatran or the countering effects of PCCs/aPCCs. In addition, PCCs or aPCCs can potentially provoke thromboembolic complications. Despite these limitations and the fact that PCCs and aPCCs are not yet licensed for dabigatran reversal, their use appears to be warranted in patients with life-threatening haemorrhage if idarucizumab is not available.
机译:达比加群有效降低房颤患者发生缺血性中风的风险。但是,像所有抗凝剂一样,它也有出血的风险。如果是外伤或急诊手术,可能需要紧急逆转达比加群引起的抗凝治疗。达比加群的特定逆转剂依达珠单抗已获得美国食品和药物管理局的批准。可以使用其他逆转剂,例如凝血酶原复合浓缩物(PCC)和活化PCC(aPCC)。在这篇综述中,我们评估了PCC和aPCC在达比加群抗凝逆转中的作用,并考虑了哪些测试适合监测这种情况下的凝血。临床前研究,小型临床研究和病例报告表明,PCC和aPCC可能能够以剂量依赖性方式逆转达比加群诱导的抗凝作用。但是,基于凝血参数的给药可能很困难,因为可用的测定可能无法提供足够的灵敏度和特异性来测量由达比加群引起的抗凝或PCC / aPCC的抵消作用。此外,PCC或aPCC可能引起血栓栓塞性并发症。尽管存在这些限制,并且PCC和aPCC尚未获得达比加群逆转的许可,但如果无法获得idarucizumab,则似乎有可能危及生命的出血患者应使用它们。

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