Imberti D, Barillari G, Biasioli C, Bianchi M, Contino L, Duce R, D'Incà M, Mameli L, Pinna L, Ageno W
Ospedale Civile, Piacenza, Italy.
Pathophysiol Haemost Thromb. 2008;36(5):259-65. doi: 10.1159/000252822. Epub 2009 Dec 9.
Intracranial haemorrhage (ICH) is a serious and potentially fatal complication of oral anticoagulant therapy (OAT). Prothrombin complex concentrates (PCCs) produce a rapid and effective reversal of OAT effects, but little evidence exists on their efficacy and safety in the management of ICH in patients on OAT.
To evaluate the efficacy and safety of PCCs for the rapid reversal of OAT in patients with ICH.
Patients suffering from acute ICH while receiving OAT were eligible for this prospective cohort study if their international normalized ratio (INR) was > or = 2.0. Stratified 35-50 IU kg(-1) PCC doses were infused based on initial INR.
A total of 92 patients (50 males; mean age 74 years, range 34-92 years) were included. The median INR at presentation was 3.3 (range 2-9). At 30 min after PCC administration the median INR was 1.4 (range 0.9-3.1), declining to < or = 1.5 in 75% of patients. The benefit of PCC was maintained for a long time, since in 98% of all post-infusion time points through 96 h the median INR remained < or = 1.5 (median 1.19; range 0.9-2.3). During hospitalization neither thrombotic complications nor significant adverse events were observed and 11 patients died (11.9%). None of the deaths was judged to be related to PCC administration.
PCC administration is an effective, rapid and safe treatment for the urgent reversal of OAT in patients with ICH. Broader use of PCC in this clinical setting appears to be appropriate.
颅内出血（ICH）是口服抗凝治疗（OAT）的一种严重且可能致命的并发症。凝血酶原复合物浓缩剂（PCCs）能快速有效地逆转OAT的作用，但关于其在接受OAT的ICH患者管理中的疗效和安全性的证据很少。
评估PCCs在ICH患者中快速逆转OAT的疗效和安全性。
正在接受OAT且发生急性ICH的患者，如果其国际标准化比值（INR）≥2.0，则符合这项前瞻性队列研究的条件。根据初始INR分层输注35 - 50 IU kg⁻¹的PCC剂量。
共纳入92例患者（50例男性；平均年龄74岁，范围34 - 92岁）。就诊时INR的中位数为3.3（范围2 - 9）。给予PCC后30分钟，INR的中位数为1.4（范围0.9 - 3.1），75%的患者INR降至≤1.5。PCC的益处持续了很长时间，因为在输注后96小时内的所有时间点中，98%的患者INR中位数保持≤1.5（中位数1.19；范围0.9 - 2.3）。住院期间未观察到血栓形成并发症或重大不良事件，11例患者死亡（11.9%）。没有死亡病例被判定与PCC给药有关。
PCC给药是ICH患者紧急逆转OAT有效、快速且安全的治疗方法。在这种临床情况下更广泛地使用PCC似乎是合适的。
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