Center for Hemorrhagic and Thrombotic Diseases, University Hospital, Udine, Italy.
Blood Transfus. 2012 Jan;10(1):87-94. doi: 10.2450/2011.0030-11. Epub 2011 Sep 22.
Prothrombin Complex Concentrates (PCC) are administered to normalise blood coagulation in patients receiving oral anticoagulant therapy (OAT). Rapid reversal of OAT is essential in case of major bleeding, internal haemorrhage or surgery.The primary end-point was to evaluate whether PCC in our hospital were being used in compliance with international and national guidelines for the reversal of OAT on an emergency basis. The secondary end-point was to evaluate the efficacy and safety of PCC.
All patients receiving OAT who required rapid reversal anticoagulation because they had to undergo emergency surgery or urgent invasive techniques following an overdose of oral anticoagulants were eligible for this retrospective observational study.
Forty-seven patients receiving OAT who needed rapid reverse of anticoagulation were enrolled in our study. The patients were divided in two groups: (i) group A (n=23), patients needed haemostatic treatment before neurosurgery after a head injury and (ii) group B (n=24), patients with critical haemorrhage because of an overdose of oral anticoagulants. The International Normalised Ratio (INR) was checked before and after infusion of the PCC. The mean INR in group A was 2.7 before and 1.43 after infusion of the PCC; in group B the mean INR of 6.58, before and 1.92 after drug infusion. The use of vitamin K, fresh-frozen plasma and red blood cells was also considered. During our study 22 patients died, but no adverse effects following PCC administration were recorded.
In our study three-factor-PCC was found to be effective and safe in rapidly reversing the effects of OAT, although it was not always administered in accordance with international or national guidelines. The dose, time of administration and monitoring often differed from those recommended. In the light of these findings, we advocate the use of single standard protocol to guide the correct use of PCC in each hospital ward.
在接受口服抗凝治疗（OAT）的患者中，使用凝血酶原复合物浓缩物（PCC）来使血液凝固正常化。在大出血、内部出血或手术的情况下，迅速逆转 OAT 至关重要。主要终点是评估我们医院的 PCC 是否在紧急情况下按照逆转 OAT 的国际和国家指南使用。次要终点是评估 PCC 的疗效和安全性。
所有因口服抗凝剂过量而需要紧急手术或紧急侵入性技术的 OAT 患者，都有资格接受这项回顾性观察研究。
我们的研究纳入了 47 名需要快速逆转抗凝的 OAT 患者。患者分为两组：（i）A 组（n=23），头部受伤后需要在神经外科手术前进行止血治疗；（ii）B 组（n=24），因口服抗凝剂过量导致严重出血。在输注 PCC 前后检查国际标准化比值（INR）。A 组的平均 INR 为 2.7，输注 PCC 后为 1.43；B 组的平均 INR 为 6.58，输注药物前和输注后为 1.92。还考虑了维生素 K、新鲜冷冻血浆和红细胞的使用。在我们的研究期间，有 22 名患者死亡，但未记录到 PCC 给药后的不良反应。
在我们的研究中，三因子 PCC 被发现能有效且安全地迅速逆转 OAT 的作用，尽管它并不总是按照国际或国家指南使用。剂量、给药时间和监测往往与推荐的不同。鉴于这些发现，我们提倡使用单一标准方案来指导每个医院病房正确使用 PCC。
