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高剂量和低剂量四因子凝血酶原复合物浓缩剂用于口服Xa因子抑制剂紧急逆转的比较

Comparison of high- and low-dose 4-factor prothrombin complex concentrate for the emergent reversal of oral Factor Xa inhibitors.

作者信息

Hormese Mary, Littler Alex, Doane Brian, Glowacki Nicole, Khimani Ann, Vivacqua Nicole, Rudenberg Karina

机构信息

Department of Pharmacy, Northwest Community Hospital, Arlington Heights, USA.

Department of Pharmacy, AMITA Health Saint Francis Hospital, Evanston, USA.

出版信息

J Thromb Thrombolysis. 2021 Oct;52(3):828-835. doi: 10.1007/s11239-021-02412-8. Epub 2021 Mar 16.

DOI:10.1007/s11239-021-02412-8
PMID:33725284
Abstract

Even though there are several reversal strategies available for oral Factor Xa inhibitor associated coagulopathies, 4-factor prothrombin complex concentrate (4F-PCC) is used commonly as the primary reversal agent at many institutions. A dose of 50 units/kg is recommended as safe and effective with growing data suggesting that a lower dosing strategy may be sufficient. This retrospective study included adult patients who received either high-dose (50 units/kg; maximum dose: 5000 units) or low-dose (25 units/kg; maximum dose: 2500 units) 4F-PCC for the emergent reversal of oral Factor Xa inhibitor-related life threatening bleeding. The primary outcome was the attainment of hemostatic effectiveness. Secondary outcomes were rates of thromboembolic events and inpatient mortality. 47 patients were included in the analysis of which 24 patients received high-dose and 23 patients received low-dose 4F-PCC. Overall hemostatic effectiveness was 87.5% in the high-dose group and 91.3% in the low-dose group. Thromboembolic event rate was 8.3% in the high-dose group compared to 4.4% within the low-dose group and inpatient mortality rate was 8.3% in the high-dose group and 4.4% in the low-dose group. Low-dose 4F-PCC (25 units/kg, maximum dose: 2500 units) for the reversal of oral Factor Xa inhibitors is a cost-effective alternative to high-dose 4F-PCC (50 units/kg; maximum dose: 5000 units) and provides effective hemostasis without increased rates of thromboembolic events or inpatient mortality.

摘要

尽管有多种逆转策略可用于口服Xa因子抑制剂相关的凝血病,但在许多机构中,4因子凝血酶原复合物浓缩剂(4F-PCC)通常被用作主要的逆转剂。随着越来越多的数据表明较低剂量策略可能就足够了,推荐50单位/千克的剂量是安全有效的。这项回顾性研究纳入了因口服Xa因子抑制剂相关的危及生命的出血而接受高剂量(50单位/千克;最大剂量:5000单位)或低剂量(25单位/千克;最大剂量:2500单位)4F-PCC紧急逆转的成年患者。主要结局是达到止血效果。次要结局是血栓栓塞事件发生率和住院死亡率。47例患者纳入分析,其中24例接受高剂量4F-PCC,23例接受低剂量4F-PCC。高剂量组的总体止血有效率为87.5%,低剂量组为91.3%。高剂量组的血栓栓塞事件发生率为8.3%,低剂量组为4.4%;高剂量组的住院死亡率为8.3%,低剂量组为4.4%。低剂量4F-PCC(25单位/千克,最大剂量:2500单位)用于逆转口服Xa因子抑制剂是高剂量4F-PCC(50单位/千克;最大剂量:5000单位)具有成本效益的替代方案,可提供有效的止血效果,且不会增加血栓栓塞事件发生率或住院死亡率。

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