Department of Pharmacy-Namur Thrombosis and Hemostasis Center, University of Namur, Namur, Belgium.
Qualiblood SA, Namur, Belgium.
Thromb Haemost. 2021 Aug;121(8):1008-1020. doi: 10.1055/a-1450-8178. Epub 2021 May 30.
In 2018, the International Council for Standardization in Haematology (ICSH) published a consensus document providing guidance for laboratories on measuring direct oral anticoagulants (DOACs). Since that publication, several significant changes related to DOACs have occurred, including the approval of a new DOAC by the Food and Drug Administration, betrixaban, and a specific DOAC reversal agent intended for use when the reversal of anticoagulation with apixaban or rivaroxaban is needed due to life-threatening or uncontrolled bleeding, andexanet alfa. In addition, this ICSH Working Party recognized areas where additional information was warranted, including patient population considerations and updates in point-of-care testing. The information in this manuscript supplements our previous ICSH DOAC laboratory guidance document. The recommendations provided are based on (1) information from peer-reviewed publications about laboratory measurement of DOACs, (2) contributing author's personal experience/expert opinion and (3) good laboratory practice.
2018 年，国际血液学标准化委员会（ICSH）发布了一份共识文件，为实验室测量直接口服抗凝剂（DOAC）提供了指导。自该文件发布以来，与 DOAC 相关的几个重大变化已经发生，包括美国食品和药物管理局（FDA）批准了一种新的 DOAC（贝曲沙班），以及一种特定的 DOAC 逆转剂，当需要逆转因危及生命或不受控制的出血而使用阿哌沙班或利伐沙班的抗凝作用时，andexanet alfa。此外，该 ICSH 工作组认识到需要更多信息的领域，包括患者人群的考虑因素和即时检测的更新。本文献中的信息补充了我们之前的 ICSH DOAC 实验室指导文件。所提供的建议基于以下几点：（1）关于 DOAC 实验室测量的同行评审出版物中的信息，（2）撰稿人个人的经验/专家意见，以及（3）良好的实验室实践。
