PDF(Pubmed)
Abstract：
Background: 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. Objective: To compare fixed versus weight-based PCC dosing for reversal of Factor Xa Inhibitor (FXaI) effects. Methods: 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. Results: 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, P = .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% (P = .57) in the fixed and weight-based groups, respectively. Conclusion and Relevance: 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.
摘要：
背景：我们的机构引入了固定剂量的凝血酶原复合物浓缩物（PCC）来简化订单验证和药物管理。先前使用固定剂量PCC逆转维生素K拮抗剂的研究显示，与基于体重的剂量相当。目的:比较固定与基于体重的PCC给药逆转因子Xa抑制剂(FXaI)效应。方法：在三级护理学术医疗中心进行回顾性队列研究。接受PCC逆转阿哌沙班或利伐沙班影响的患者符合资格。将固定剂量组(5000单位或2000单位)的受试者与基于体重的PCC(50单位/kg)进行比较。主要结果是订单输入和药物管理之间的时间。次要结果包括：平均PCC剂量，后期管理程序,实现止血，30天死亡率，住院时间,和不良药物事件。结果：72例患者接受固定剂量PCC，101例接受基于体重的PCC。与基于体重的组相比，固定剂量组的订单输入和给药之间的中位时间短了4.5分钟（34.5vs39分钟，P=.10）。在接受固定剂量的患者中，79.2％实现止血，而基于体重的组实现止血为71.3％（RR=1.11，95％CI=0.94-1.32）。随后的出血相关手术的数量没有差异（29.2％vs36.7％，RR=0.80，95%CI=0.51-1.24）或死亡率（26.4%vs35.6%，RR=0.73，95%CI=0.46-1.17）。报告的药物不良事件为零。固定组和基于体重的组的血栓形成率分别为2.8%和<1%(P=0.57)。分别。结论和相关性：固定给药策略不会缩短PCC给药时间，也不会影响止血或死亡率。这些数据支持固定给药方法是可行的选择。
