University of Colorado Health-North, Fort Collins, CO, USA.
The University of Tennessee Health Sciences Center, Knoxville, TN, USA.
Ann Pharmacother. 2021 Aug;55(8):980-987. doi: 10.1177/1060028020978568. Epub 2020 Dec 11.
The ideal dose and specific prothrombin complex concentrate (PCC) for warfarin reversal is unknown.
To evaluate the reduction in international normalized ratio (INR) of 3 different PCC dosing regimens: fixed-dose activated 4-factor PCC (aPCC), fixed-dose 4-factor PCC (4PCC), and standard-dose 4PCC.
This was a multicenter retrospective cohort review. Patients >18 years of age who received PCC for warfarin reversal between January 1, 2017, and December 31, 2017, were screened for inclusion. Patients were excluded if they did not receive the correct PCC dosing regimen, received PCC for nonwarfarin bleeding, had a baseline INR less than 2, or received a massive transfusion protocol. Two institutions utilized aPCC dosed at 500 IU for INR <5 and 1000 IU for INR ≥5. Two institutions utilized fixed-dose 4PCC at 1500 to 2000 units depending on patient factors. Two institutions utilized 4PCC package insert dosing. The primary outcome was achievement of post-PCC target INR ≤1.4. Secondary outcomes included percentage change in INR, lowest 24-hour INR, and mortality.
A total of 154 patients were included (fixed-dose aPCC: n = 29; fixed-dose 4PCC: n = 53; standard-dose 4PCC: n = 72). There was no statistical difference between groups in achieving the primary outcome (58.6% vs 69.8% vs 79.2%, respectively; = 0.103) or any secondary outcomes.
There was no difference in the ability to achieve a post-PCC INR of ≤1.4 between 3 different PCC regimens for warfarin reversal. Additional research is warranted to determine the ideal dose and PCC agent for warfarin reversal.
目前尚不清楚逆转华法林抗凝作用的理想剂量和特定的凝血酶原复合物浓缩物（PCC）。
评估 3 种不同 PCC 给药方案（固定剂量活化 4 因子 PCC[aPCC]、固定剂量 4 因子 PCC[4PCC]和标准剂量 4PCC）的国际标准化比值（INR）降低情况。
这是一项多中心回顾性队列研究。筛选 2017 年 1 月 1 日至 2017 年 12 月 31 日期间因华法林逆转而接受 PCC 治疗的年龄＞18 岁的患者，纳入符合条件的患者。排除基线 INR＜2 或接受大量输血方案的患者。有 2 家机构采用 aPCC 治疗 INR＜5 的患者时剂量为 500IU，治疗 INR≥5 的患者时剂量为 1000IU。有 2 家机构采用固定剂量 4PCC，剂量取决于患者的具体情况，为 1500~2000 单位。有 2 家机构采用 4PCC 包装插页推荐剂量。主要结局为达到 PCC 后目标 INR≤1.4。次要结局包括 INR 变化百分比、最低 24 小时 INR 和死亡率。
共纳入 154 例患者（固定剂量 aPCC：n=29；固定剂量 4PCC：n=53；标准剂量 4PCC：n=72）。3 种 PCC 方案在达到主要结局（分别为 58.6%、69.8%和 79.2%；χ²=0.103，P=0.914）或任何次要结局方面无统计学差异。
3 种不同的 PCC 方案在逆转华法林抗凝作用方面，达到 PCC 后 INR≤1.4 的能力无差异。需要进一步研究以确定华法林逆转的理想剂量和 PCC 制剂。
