Department of Pharmacy, UPMC Mercy, Pittsburgh, PA, USA.
School of Pharmacy, Duquesne University, Pittsburgh, PA, USA.
Clin Appl Thromb Hemost. 2024 Jan-Dec;30:10760296241243368. doi: 10.1177/10760296241243368.
Our institution introduced fixed-dose prothrombin complex concentrate (PCC) to streamline order verification and medication administration. Previous studies using fixed-dose PCC for vitamin K antagonist reversal showed comparable efficacy to weight-based dosing. To compare fixed versus weight-based PCC dosing for reversal of Factor Xa Inhibitor (FXaI) effects. Retrospective cohort study conducted at a tertiary care academic medical center. Patients who received PCC to reverse the effects of apixaban or rivaroxaban were eligible. Subjects in the fixed-dose group (5000 units or 2000 units) were compared to weight-based PCC (50 units/kg). The primary outcome was time between order entry and medication administration. Secondary outcomes included: average PCC dose, postadministration procedures, achieved hemostasis, 30-day mortality, hospital length of stay, and adverse drug events. 72 patients received fixed-dose PCC and 101 received weight-based PCC. Median time between order entry and administration was 4.5 min shorter in the fixed-dose group compared to weight-based (34.5 vs 39 min, = .10). In patients who received fixed-dose, 79.2% achieved hemostasis versus 71.3% in the weight-based group (RR = 1.11, 95% CI = 0.94-1.32). There was no difference in the number of subsequent hemorrhage-related surgeries (29.2% vs 36.7%, RR = 0.80, 95% CI = 0.51-1.24) or mortality rate (26.4% vs 35.6%, RR = 0.73, 95% CI = 0.46-1.17). There were zero adverse drug events reported. Rates of thrombosis were 2.8% and < 1% ( = .57) in the fixed and weight-based groups, respectively. The fixed-dosing strategy did not reduce time to PCC administration nor impact hemostasis or mortality. These data support that the fixed-dosing method is a viable option.
我们机构引入了固定剂量的凝血酶原复合物浓缩物（PCC），以简化医嘱核对和药物管理。先前使用固定剂量 PCC 逆转维生素 K 拮抗剂的研究表明，其疗效与基于体重的剂量相当。比较固定剂量与基于体重的 PCC 剂量在逆转因子 Xa 抑制剂（FXaI）作用方面的效果。这是一项在三级保健学术医疗中心进行的回顾性队列研究。入组标准为接受 PCC 逆转阿哌沙班或利伐沙班作用的患者。固定剂量组（5000 单位或 2000 单位）和基于体重的 PCC 组（50 单位/公斤）进行比较。主要结局是从医嘱下达到药物给药之间的时间。次要结局包括：PCC 平均剂量、给药后程序、达到止血、30 天死亡率、住院时间和药物不良事件。72 例患者接受了固定剂量 PCC，101 例患者接受了基于体重的 PCC。与基于体重的 PCC 相比，固定剂量组的医嘱下达到给药之间的中位时间缩短了 4.5 分钟（34.5 与 39 分钟， = .10）。在接受固定剂量 PCC 的患者中，79.2%达到止血，而基于体重的 PCC 组为 71.3%（RR = 1.11，95%CI = 0.94-1.32）。随后因出血相关手术的数量无差异（29.2%与 36.7%，RR = 0.80，95%CI = 0.51-1.24）或死亡率（26.4%与 35.6%，RR = 0.73，95%CI = 0.46-1.17）。无药物不良事件报告。固定剂量组和基于体重的 PCC 组的血栓形成率分别为 2.8%和 < 1%（ = .57）。固定剂量策略并未缩短 PCC 给药时间，也未影响止血或死亡率。这些数据支持固定剂量方法是可行的选择。
