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艾达赛珠单抗用于逆转达比加群抗凝作用的批判性评价

Use of idarucizumab in reversing dabigatran anticoagulant effect: a critical appraisal.

作者信息

Proietti Marco, Boriani Giuseppe

机构信息

Department of Neuroscience, I Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy.

Institute of Cardiovascular Sciences, Universit of Birmingham, Birmingham, UK.

出版信息

Ther Clin Risk Manag. 2018 Aug 22;14:1483-1488. doi: 10.2147/TCRM.S140377. eCollection 2018.

DOI:10.2147/TCRM.S140377
PMID:30174430
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6110633/
Abstract

Use of non-vitamin K antagonist oral anticoagulants is spreading in the real world. Despite that, a strong need for antidotes/reversal agents is still reported by several physicians. Idarucizumab is a humanized monoclonal antibody fragment that binds specifically to dabigatran. Idarucizumab was approved in 2015 by the US Food and Drugs Administration and European Medicines Agency for reversal of anticoagulation activity in dabigatrantreated patients. This review briefly summarizes the experimental evidence about effectiveness and safety of idarucizumab. Furthermore, we review the current recommendations and experts' point of view about the use of antidotes/reversal agents in patients reporting a major bleeding event.

摘要

在现实世界中,非维生素K拮抗剂口服抗凝药的使用正在不断普及。尽管如此,仍有多位医生表示对抗凝解毒剂/逆转剂有强烈需求。依达赛珠单抗是一种特异性结合达比加群的人源化单克隆抗体片段。2015年,依达赛珠单抗获美国食品药品监督管理局和欧洲药品管理局批准,用于逆转达比加群治疗患者的抗凝活性。本综述简要总结了关于依达赛珠单抗有效性和安全性的实验证据。此外,我们还综述了目前关于在发生重大出血事件的患者中使用解毒剂/逆转剂的建议和专家观点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0f8/6110633/4e289b3eb85b/tcrm-14-1483Fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0f8/6110633/4e289b3eb85b/tcrm-14-1483Fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0f8/6110633/4e289b3eb85b/tcrm-14-1483Fig1.jpg

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Use of idarucizumab in reversing dabigatran anticoagulant effect: a critical appraisal.艾达赛珠单抗用于逆转达比加群抗凝作用的批判性评价
Ther Clin Risk Manag. 2018 Aug 22;14:1483-1488. doi: 10.2147/TCRM.S140377. eCollection 2018.
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本文引用的文献

1
What Surgeons Should Know About Non-Vitamin K Oral Anticoagulants: A Review.外科医生应该了解的非维生素 K 口服抗凝剂:综述。
JAMA Surg. 2018 Jun 1;153(6):577-585. doi: 10.1001/jamasurg.2018.0374.
2
Reversal agents for non-vitamin K antagonist oral anticoagulants.非维生素 K 拮抗剂口服抗凝剂的逆转剂。
Nat Rev Cardiol. 2018 May;15(5):273-281. doi: 10.1038/nrcardio.2017.223. Epub 2018 Jan 18.
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2017年美国心脏病学会口服抗凝剂治疗患者出血管理专家共识决策路径:美国心脏病学会专家共识决策路径特别工作组报告
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4
Idarucizumab since FDA approval: Use in the real-world.自美国食品药品监督管理局批准以来的依达赛珠单抗:在现实世界中的应用。
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Bleeding related to non-vitamin K antagonist oral anticoagulants in emergency department: A "Real-world" snapshot from Southern Italy. On behalf of MIRC-NOAC study group.
Eur J Intern Med. 2018 Feb;48:e21-e24. doi: 10.1016/j.ejim.2017.10.018. Epub 2017 Nov 1.
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Idarucizumab for Dabigatran Reversal - Full Cohort Analysis.达比加群酯逆转剂依达鲁珠单抗:全队列分析。
N Engl J Med. 2017 Aug 3;377(5):431-441. doi: 10.1056/NEJMoa1707278. Epub 2017 Jul 11.
7
Adherence to oral anticoagulant therapy in patients with atrial fibrillation. Focus on non-vitamin K antagonist oral anticoagulants.心房颤动患者口服抗凝治疗的依从性。聚焦于非维生素K拮抗剂口服抗凝药。
Thromb Haemost. 2017 Jan 26;117(2):209-218. doi: 10.1160/TH16-10-0757. Epub 2016 Nov 10.
8
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS.2016年欧洲心脏病学会(ESC)与欧洲心胸外科学会(EACTS)合作制定的心房颤动管理指南。
Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27.
9
Reversal strategies for non-vitamin K antagonist oral anticoagulants: a critical appraisal of available evidence and recommendations for clinical management-a joint position paper of the European Society of Cardiology Working Group on Cardiovascular Pharmacotherapy and European Society of Cardiology Working Group on Thrombosis.非维生素K拮抗剂口服抗凝药的逆转策略:现有证据的批判性评估及临床管理建议——欧洲心脏病学会心血管药物治疗工作组和欧洲心脏病学会血栓形成工作组的联合立场文件
Eur Heart J. 2017 Jun 7;38(22):1710-1716. doi: 10.1093/eurheartj/ehv676.
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Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity.依达赛珠单抗用于逆转 Xa 因子抑制剂的活性。
N Engl J Med. 2015 Dec 17;373(25):2413-24. doi: 10.1056/NEJMoa1510991. Epub 2015 Nov 11.