Jones G Morgan, Cave Brandon, Cook Ryan
Department of Pharmacy, Methodist University Hospital, Memphis, TN, USA.
Department of Clinical Pharmacy, University of Tennessee Health Sciences Center (UTHSC), Memphis, TN, USA.
Neurohospitalist. 2020 Jul;10(3):201-207. doi: 10.1177/1941874420905755. Epub 2020 Mar 4.
Current guidelines suggest that 3-factor prothrombin complex concentrate is a possible alternative to 4-factor products for the emergent reversal of bleeding secondary to warfarin. While multiple observational studies have evaluated various forms of 3-factor prothrombin complex concentrate individually, no study has compared the efficacy of the 2 products. The purpose of this study is to compare the efficacy and safety of Bebulin™ and Profilnine™ for the emergent reversal of warfarin-associated major bleeding.
We conducted a retrospective cohort study of patients receiving both Bebulin™ and Profilnine™ at an urban, academic medical center with comprehensive stroke center designation and a neurosurgical center of excellence. All patients were treated at a single center that utilized a fixed, weight-based dosing protocol. The primary outcome was the percentage of patients in each group achieving a goal international normalization ratio of 1.4 or less.
There was a significant difference in goal international normalization ratio achieved favoring Bebulin™ (85.5% vs 27.3%; < .001) over Profilnine™. Median dose per kilogram of actual body weight was the same between the groups. When we assessed results by baseline™ international normalization ratio subgroup, more patients in the Bebulin™ group achieved goal when baseline values were 6 or less. No thrombotic events were documented in either group.
We found that patients treated with Bebulin™ experienced significantly higher rates of successful international normalization ratio reversal when compared to those who received Profilnine™. Further research is needed to determine the comparative efficacy between the 2 agents.
当前指南表明，对于华法林所致出血的紧急逆转，三因子凝血酶原复合物浓缩剂可能是四因子产品的一种替代选择。虽然多项观察性研究已分别评估了各种形式的三因子凝血酶原复合物浓缩剂，但尚无研究比较这两种产品的疗效。本研究的目的是比较百布灵™（Bebulin™）和普罗菲林™（Profilnine™）用于紧急逆转华法林相关严重出血的疗效和安全性。
我们在一家具有综合卒中中心资质和卓越神经外科中心的城市学术医疗中心，对接受百布灵™和普罗菲林™治疗的患者进行了一项回顾性队列研究。所有患者均在单一中心接受治疗，该中心采用基于体重的固定给药方案。主要结局是每组中达到国际标准化比值目标值1.4或更低的患者百分比。
在实现国际标准化比值目标方面，百布灵™组（85.5%对27.3%；P<0.001）显著优于普罗菲林™组。两组每千克实际体重的中位剂量相同。当我们按基线国际标准化比值亚组评估结果时，基线值为6或更低时，百布灵™组有更多患者达到目标值。两组均未记录到血栓形成事件。
我们发现，与接受普罗菲林™治疗者相比，接受百布灵™治疗的患者成功逆转国际标准化比值的发生率显著更高。需要进一步研究以确定这两种药物之间的相对疗效。
