关键词: Andexanet alfa Antidote Ciraparantag Direct oral anticoagulant Idarucizumab Laboratory monitoring

Mesh : Humans Antidotes / therapeutic use Anticoagulants / therapeutic use Administration, Oral Factor Xa Inhibitors / therapeutic use Drug Monitoring / methods Recombinant Proteins Factor Xa Antibodies, Monoclonal, Humanized

来  源:   DOI:10.1016/j.thromres.2024.04.005

Abstract:
Given the growing number of patients receiving direct oral anticoagulant (DOAC), patients requiring rapid neutralization is also increasing in case of major bleedings or urgent surgery/procedures. Idarucizumab is commercialized as a specific antidote to dabigatran while andexanet alfa has gained the Food and Drug Administration and the European Medicines Agency approval as an oral anti-factor Xa inhibitors antidote. Other antidotes or hemostatic agents are still under preclinical or clinical development, the most advanced being ciraparantag. DOAC plasma levels measurement allows to appropriately select patient for antidote administration and may prevent unnecessary prescription of expensive molecules in some acute clinical settings. However, these tests might be inconclusive after some antidote administration, namely andexanet alfa and ciraparantag. The benefit of laboratory monitoring following DOAC reversal remains unclear. Here, we sought to provide an overview of the key studies evaluating the safety and efficacy of DOAC reversal using the most developed/commercialized specific antidotes, to discuss the potential role of the laboratory monitoring in the management of patients receiving DOAC specific antidotes and to highlight the areas that deserve further investigations in order to establish the exact role of laboratory monitoring in the appropriate management of DOAC specific antidotes.
摘要:
鉴于接受直接口服抗凝剂(DOAC)的患者数量不断增加,在严重出血或紧急手术/程序的情况下,需要快速中和的患者也在增加。Idarucizumab已被商业化为达比加群的特异性解毒剂,而andexanetalfa已获得食品药品监督管理局和欧洲药品管理局的批准,成为口服抗因子Xa抑制剂解毒剂。其他解毒剂或止血剂仍在临床前或临床开发中,最先进的是马戏团。DOAC血浆水平测量允许适当地选择用于解毒剂施用的患者,并且可以防止在一些急性临床环境中不必要的昂贵分子的处方。然而,在一些解毒剂施用后,这些测试可能没有定论,即andexanetalfa和ciraparantag。DOAC逆转后实验室监测的益处尚不清楚。这里,我们试图提供评估使用最发达/商业化的特异性解毒剂的DOAC逆转的安全性和有效性的关键研究的概述。讨论实验室监测在接受DOAC特异性解毒剂的患者管理中的潜在作用,并强调值得进一步研究的领域,以确定实验室监测在DOAC特异性解毒剂的适当管理中的确切作用。
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