Alfred Pathology Service, Clinical Haematology Department, Alfred Hospital, Commercial Road, Prahran, Melbourne, Vic. 3181, Australia.
Intern Med J. 2011 Apr;41(4):337-43. doi: 10.1111/j.1445-5994.2010.02237.x.
Prothrombinex-VF (a three-factor prothrombin complex concentrate) contains little factor VII. Therefore, the Warfarin Reversal Consensus Guidelines from 2004 published by The Australasian Society of Haemostasis and Thrombosis recommend that it be administered with fresh frozen plasma to reverse warfarin anticoagulation.
To evaluate the efficacy and safety of Prothrombinex-VF used alone in warfarin reversal.
Adult patients requiring urgent reversal of warfarin anticoagulation were defined as having achieved complete (target international normalized ratio (INR) <1.4) or partial reversal (target INR 1.4-2.0) of their anticoagulation. Prothrombinex-VF was given at doses of between 25 and 50 IU/kg based on the intent of reversal and an INR was obtained 30min post infusion.
A total of 50 patients (mean age 72years, range 32-85years) was included. The median initial INR in the complete reversal arm (n= 35) was 3.5 (range 1.7-20) with 91% achieving the target INR (mean 1.1, range 0.9-1.4). In the partial reversal arm (n= 15) the mean initial INR was 5.6 (range 2.5-12) with 93% achieving the target INR (mean 1.6, range 1.4-2.2). There were no adverse effects attributed to Prothrombinex-VF.
Prothrombinex-VF is very effective and safe when used alone to reverse warfarin anticoagulation. The supplementary use of fresh frozen plasma in these patients is not required. A review of the current Warfarin Reversal Consensus Guidelines is needed.
Prothrombinex-VF(一种三因子凝血酶原复合物浓缩物)中因子 VII 的含量较低。因此,2004 年《澳大利亚血栓与止血协会》发布的《华法林逆转共识指南》建议,在逆转华法林抗凝时,应与新鲜冷冻血浆联合使用。
评估 Prothrombinex-VF 单独用于华法林逆转的疗效和安全性。
将需要紧急逆转华法林抗凝的成年患者定义为达到抗凝完全逆转(目标国际标准化比值(INR)<1.4)或部分逆转(目标 INR 为 1.4-2.0)。根据逆转的意图,给予 25-50IU/kg 的 Prothrombinex-VF,输注后 30min 测定 INR。
共纳入 50 例患者(平均年龄 72 岁,范围 32-85 岁)。完全逆转组(n=35)的初始 INR 中位数为 3.5(范围 1.7-20),91%达到目标 INR(平均 1.1,范围 0.9-1.4)。部分逆转组(n=15)的初始 INR 平均值为 5.6(范围 2.5-12),93%达到目标 INR(平均 1.6,范围 1.4-2.2)。未发生归因于 Prothrombinex-VF 的不良反应。
Prothrombinex-VF 单独用于逆转华法林抗凝非常有效且安全,无需在这些患者中补充使用新鲜冷冻血浆。需要对当前的《华法林逆转共识指南》进行审查。