低固定剂量与高体重剂量重组凝血因子VIIa治疗华法林相关颅内出血的比较。

Comparison of a low, fixed dose and a high, weight-based dose of recombinant factor VIIa in the treatment of warfarin-associated intracranial hemorrhage.

作者信息

Robbins Adele, Fong Jeffrey, Hall Wiley, Ditch Kristen, Rolfe Stephen, Miller Melissa

机构信息

Department of Pharmacy, Wake Forest University Baptist Medical Center, Medical Center Blvd, Winston Salem, NC, 27157, USA,

出版信息

Neurocrit Care. 2014 Jun;20(3):466-9. doi: 10.1007/s12028-013-9841-2.

DOI:10.1007/s12028-013-9841-2

PMID:23595666

Abstract

BACKGROUND

Recombinant activated Factor VII (rFVIIa) can be used for rapid INR normalization in patients with warfarin-associated intracranial hemorrhage (WA-ICH); however, the optimal dose to normalize INR has not been established.

METHODS

This is a retrospective review comparing two rFVIIa hospital protocols for WA-ICH [weight-based dose (80 mcg/kg) or fixed dose (2 mg)]. Primary endpoint was the percentage of patients with INR reversal (INR <1.3) at the next INR draw and the need for further doses of rFVIIa. Secondary endpoints included time to documented INR reversal and sustained INR normalization, morbidity, mortality, change in hematoma size, cost, and adverse drug reactions.

RESULTS

Twenty-nine patients were included in each group. The weight-based group received a mean dose of 78.9 ± 21 mcg/kg versus 26.6 ± 8 mcg/kg in the fixed dose group. More patients in the fixed dose protocol achieved documented INR reversal than those in the weight-based group (92.6 vs 72.4 %, p = 0.19). The weight-based group achieved INR normalization in 229.5 [102, 331] minutes versus 165 [83, 447] minutes in the fixed dose group (p=0.02). Time to sustained INR normalization was similar in both groups. Four patients in the fixed dose group received an additional dose of 1 mg per hospital protocol. With the exception of medication acquisition cost savings of about $4,300 per patient who received fixed dose protocol, all other endpoints were similar between groups.

CONCLUSIONS

A low, fixed dose of rFVIIa appears to be as effective as a high, weight-based dose in achieving INR normalization in patients with WA-ICH.

摘要

背景

重组活化凝血因子 VII（rFVIIa）可用于华法林相关颅内出血（WA-ICH）患者快速使国际标准化比值（INR）正常化；然而，使 INR 正常化的最佳剂量尚未确定。

方法

这是一项回顾性研究，比较两种用于 WA-ICH 的 rFVIIa 医院方案[基于体重的剂量（80 微克/千克）或固定剂量（2 毫克）]。主要终点是下次 INR 检测时 INR 逆转（INR<1.3）的患者百分比以及对额外剂量 rFVIIa 的需求。次要终点包括记录到 INR 逆转的时间、持续 INR 正常化、发病率、死亡率、血肿大小变化、成本和药物不良反应。

结果

每组纳入 29 例患者。基于体重的组平均剂量为 78.9±21 微克/千克，而固定剂量组为 26.6±8 微克/千克。固定剂量方案中实现记录到 INR 逆转的患者比基于体重的组更多（92.6%对 72.4%，p = 0.19）。基于体重的组在 229.5[102, 331]分钟实现 INR 正常化，而固定剂量组为 165[83, 447]分钟（p = 0.02）。两组持续 INR 正常化的时间相似。固定剂量组有 4 例患者根据医院方案额外接受了 1 毫克剂量。除了接受固定剂量方案的患者每人节省约 4300 美元的药物购置成本外，两组之间所有其他终点相似。