Mancl Erin E, Crawford Alexis N, Voils Stacy A
Department of Pharmacy Services, Virginia Commonwealth University Health System, Medical College of Virginia Campus, Richmond, VA, USA.
J Pharm Pract. 2013 Feb;26(1):43-51. doi: 10.1177/0897190012465989. Epub 2012 Nov 16.
Several oral direct thrombin inhibitors (DTIs) and factor Xa (FXa) inhibitors have recent Food and Drug Administration approval or are under investigation in late-stage clinical trials for the prevention and treatment of thromboembolic events. Rapid reversal of anticoagulation is typically recommended in patients with severe or life-threatening bleeding and in patients requiring surgery or invasive procedures. However, no antidote exists for DTIs or FXa inhibitors though replacement of coagulation factors using clotting factor concentrates is routinely considered in some clinical scenarios. Clotting factor concentrates available in the United States include prothrombin complex concentrate, activated prothrombin complex concentrate, and recombinant factor VII, activated. Coagulation tests to confirm adequate reversal of anticoagulation should be considered and commonly include activated partial thromboplastin time and thrombin time (TT) for DTIs, and chromogenic FXa assay and TT for FXa inhibitors. Monitoring of coagulation tests should continue for 1 to 2 days after achievement of hemostasis, since the duration of the clotting factor concentrate may be shorter than the oral anticoagulant, especially in patients with organ dysfunction. Utilization of decision-support tools and use of standardized reversal protocols are recommended to prevent errors in prescribing and dispensing for clotting factor concentrates.
几种口服直接凝血酶抑制剂(DTIs)和Xa因子(FXa)抑制剂最近已获得美国食品药品监督管理局的批准,或正在进行后期临床试验,用于预防和治疗血栓栓塞事件。对于严重或危及生命的出血患者以及需要进行手术或侵入性操作的患者,通常建议迅速逆转抗凝作用。然而,DTIs或FXa抑制剂没有解毒剂,尽管在某些临床情况下,常规会考虑使用凝血因子浓缩物替代凝血因子。美国可用的凝血因子浓缩物包括凝血酶原复合物浓缩物、活化凝血酶原复合物浓缩物和重组活化VII因子。应考虑进行凝血试验以确认抗凝作用得到充分逆转,对于DTIs,通常包括活化部分凝血活酶时间和凝血酶时间(TT),对于FXa抑制剂,则包括发色底物法FXa测定和TT。止血后应持续监测凝血试验1至2天,因为凝血因子浓缩物的作用持续时间可能短于口服抗凝剂,尤其是在器官功能障碍患者中。建议使用决策支持工具并采用标准化的逆转方案,以防止在凝血因子浓缩物的处方和配药过程中出现错误。