Introduction

Despite an increase in the use of fixed-dose protocols of 4-factor prothrombin complex concentrate (4F-PCC) for the reversal of vitamin K antagonists (VKAs), there remains a paucity of data in obese patients. In this study, we aimed to compare the proportion of patients attaining international normalized ratio (INR) goals using a weight-based dosing strategy versus a fixed-dose regimen of 4F-PCC.

Methods

This was a retrospective study conducted in patients 18 years of age or older, weighing ≥ 100 kg, who received either a weight-based dose or fixed dose of 4F-PCC (2000 units) for the reversal of VKA, and had a documented baseline and post-treatment INR. The primary outcome was the proportion of patients achieving an INR of < 2 for all indications of warfarin reversal, except in patients with intracranial hemorrhage, where the goal was an INR of < 1.5.

Results

A total of 44 patients met the inclusion criteria; 25 patients in the weight-based dosing group and 19 patients in the fixed-dose group. The median baseline INR was similar in both groups (weight-based dosing group 3.2 [interquartile range {IQR} 2.8–3.7] vs fixed-dose group 3.0 [IQR 2.7–4.9], p = 1). The median post-treatment INR was significantly lower in the weight-based dosing group compared to the fixed-dose group (1.3 [IQR 1.2–1.5] vs 1.6 [IQR 1.5–1.9], p < 0.01). However, there was no significant difference in the primary outcome between both groups (weight-based dosing strategy 84% vs fixed dose strategy 90%, p = 0.68).

Conclusion

Our findings suggest that a fixed-dose regimen of 2000 units in obese patients weighing ≥ 100 kg is adequate to achieve these INR goals.

中文翻译：

---

在需要逆转维生素 K 拮抗剂的肥胖患者中，基于体重的给药方案与固定剂量的 4 因子凝血酶原复合物浓缩物方案

介绍

尽管使用固定剂量的 4 因子凝血酶原复合物浓缩物 (4F-PCC) 来逆转维生素 K 拮抗剂 (VKA)，但肥胖患者的数据仍然缺乏。在本研究中，我们旨在比较使用基于体重的给药策略与固定剂量 4F-PCC 方案达到国际标准化比率 (INR) 目标的患者比例。

方法

这是一项回顾性研究，在 18 岁或以上、体重 ≥ 100 kg 的患者中进行，这些患者接受了基于体重的剂量或固定剂量的 4F-PCC（2000 单位）以逆转 VKA，并有记录的基线和治疗后INR。主要结果是在所有华法林逆转指征中达到 INR < 2 的患者比例，颅内出血患者除外，其目标是 INR < 1.5。

结果

共44例患者符合纳入标准；体重给药组25例患者，固定剂量组19例患者。两组的中位基线 INR 相似（基于体重的给药组 3.2 [四分位距 {IQR} 2.8-3.7] 与固定剂量组 3.0 [IQR 2.7-4.9]，p  = 1）。与固定剂量组相比，基于体重的给药组的治疗后 INR 中位数显着降低（1.3 [IQR 1.2-1.5] vs 1.6 [IQR 1.5-1.9]，p  < 0.01）。然而，两组之间的主要结果没有显着差异（基于体重的给药策略 84% 与固定剂量策略 90%，p  = 0.68）。

结论

我们的研究结果表明，体重 ≥ 100 kg 的肥胖患者 2000 单位的固定剂量方案足以实现这些 INR 目标。