1 North Shore Medical Center Salem Hospital, Salem, MA, USA.
2 MCPHS University, Boston, MA, USA.
Ann Pharmacother. 2018 May;52(5):454-461. doi: 10.1177/1060028017750397. Epub 2018 Jan 9.
Therapeutic options for rapid reversal of vitamin K antagonist therapy include 4-factor prothrombin complex concentrate (PCC4) and fresh frozen plasma (FFP). These agents have unique requirements for preparation, potential adverse effects, and cost-effectiveness considerations.
To retrospectively assess whether our process for collaborative prospective review and pharmacy preparation facilitates timely and safe warfarin reversal with PCC4 as compared with FFP and to compare effectiveness and safety of the agents in practice.
We performed a retrospective, single-center, before and after cohort study of patients requiring warfarin reversal for life-threatening bleeding or urgent invasive procedures over an 18-month period. The primary end point was time from ordering of reversal agent to administration. Secondary end points measured time to therapeutic effect and rates of adverse events.
Of 98 patients studied, 72 received FFP, and 26 received PCC4. The median times from ordering to administration of FFP and PCC4 were 69 and 44 minutes, respectively ( P = 0.015). Median time from ordering to end of infusion was significantly shorter for PCC4 compared with FFP (54 vs 151 minutes, respectively; P < 0.0001). In all, 72% of PCC4 patients and 28% of FFP patients achieved the goal international normalized ratio (INR) of ≤1.4 at the first INR check ( P < 0.0001). Adverse reactions occurred in 4% of patients in each group.
In routine clinical practice incorporating collaborative prospective review and dispensing from the institution's pharmacy, PCC4 was associated with faster administration, a higher rate of INR correction, and similar rates of adverse events compared with FFP.
维生素 K 拮抗剂治疗的快速逆转治疗选择包括 4 因子凝血酶原复合物浓缩物（PCC4）和新鲜冷冻血浆（FFP）。这些药物在制备、潜在不良反应和成本效益方面具有独特的要求。
回顾性评估我们的协作前瞻性审查和药房准备流程是否有助于与 FFP 相比，更快速、安全地使用 PCC4 逆转华法林，以及比较这些药物在实际应用中的效果和安全性。
我们进行了一项回顾性、单中心、前后队列研究，研究对象为在 18 个月内因危及生命的出血或紧急侵入性手术而需要华法林逆转的患者。主要终点是从订购逆转药物到给药的时间。次要终点测量达到治疗效果的时间和不良事件的发生率。
在 98 名研究患者中，72 名患者接受了 FFP，26 名患者接受了 PCC4。FFP 和 PCC4 从下订单到给药的中位数时间分别为 69 和 44 分钟（P=0.015）。与 FFP 相比，PCC4 从下订单到输注结束的中位数时间明显更短（分别为 54 与 151 分钟；P<0.0001）。在所有患者中，72%的 PCC4 患者和 28%的 FFP 患者在第一次 INR 检查时达到了 INR≤1.4 的目标（P<0.0001）。每组患者均有 4%出现不良反应。
在纳入协作前瞻性审查和从机构药房配药的常规临床实践中，与 FFP 相比，PCC4 给药更快，INR 校正率更高，不良事件发生率相似。
