Rivosecchi Ryan M, Durkin Joseph, Okonkwo David O, Molyneaux Bradley J
Department of Pharmacy, UPMC Presbyterian Hospital, Pittsburgh, PA, USA.
Department of Neurologic Surgery, University of Pittsburgh, Pittsburgh, PA, USA.
Neurocrit Care. 2016 Dec;25(3):359-364. doi: 10.1007/s12028-016-0271-9.
The use of vitamin K antagonists is an independent risk factor for the development of intracerebral hemorrhage (ICH). Four-factor prothrombin complex concentrate (4F-PCC) is recommended for urgent reversal of anticoagulation in this setting. The safety and efficacy of 4F-PCC in ICH with subtherapeutic levels of anticoagulation is yet to be determined.
This was a retrospective, observational study of 4F-PCC administration data from September 2013 to July 2015. Patients with spontaneous or traumatic ICH with initial INR 1.4-1.9 were compared to those with INR 2-3.9. A Fisher's exact test was used to compare the difference between the two groups in the effectiveness of 4F-PCC in reversing the INR to ≤1.3 and in the occurrence of thrombotic events within 7 days of administration.
A total of 131 patients with a presenting INR between 1.4 and 3.9 received 4F-PCC during the study period. Twenty-three of 29 patients (79 %) in the INR <2 group achieved an INR reduction to ≤1.3 after 4F-PCC administration compared to 47 of 92 patients (51 %) in the INR 2-4 group, p = 0.03. There was no difference in thrombotic complications within 7 days after administration (6.7 % in INR 1.4-1.9 group, 10 % in INR 2-3.9 group, p = 0.73).
The use of 4F-PCC in patients with INR between 1.4 and 1.9 results in an effective reduction in INR with similar thrombotic risks compared to patients presenting with an INR of 2-3.9.
使用维生素K拮抗剂是发生脑出血（ICH）的一个独立危险因素。在这种情况下，推荐使用四因子凝血酶原复合物浓缩剂（4F-PCC）紧急逆转抗凝作用。4F-PCC在抗凝水平低于治疗范围的ICH患者中的安全性和有效性尚未确定。
这是一项对2013年9月至2015年7月期间4F-PCC给药数据的回顾性观察研究。将初始国际标准化比值（INR）为1.4 - 1.9的自发性或创伤性ICH患者与INR为2 - 3.9的患者进行比较。采用Fisher精确检验比较两组在4F-PCC将INR逆转至≤1.3的有效性以及给药后7天内血栓形成事件发生率方面的差异。
在研究期间，共有131例初始INR在1.4至3.9之间的患者接受了4F-PCC治疗。INR<2组的29例患者中有23例（79%）在给予4F-PCC后INR降至≤1.3，而INR为2 - 4组的92例患者中有47例（51%），p = 0.03。给药后7天内血栓形成并发症无差异（INR 1.4 - 1.9组为6.7%，INR 2 - 3.9组为10%，p = 0.73）。
与INR为2 - 3.9的患者相比，在INR为1.4至1.9的患者中使用4F-PCC可有效降低INR，且血栓形成风险相似。
