Leal-Noval Santiago R, López-Irizo Rosa, Bautista-Paloma Javier, Casado Manuel, Arellano-Orden Victoria, Leal-Romero María, Fernández-Hinojosa Esteban, Puppo-Moreno Antonio, Muñoz Manuel
aCritical Care bPharmacy Divisions, Hospital Universitario "Virgen del Rocío" and Instituto de Biomedicina de Sevilla [IBIS], Seville cGIEMSA, Transfusion Medicine, University of Malaga, Málaga, Spain.
Blood Coagul Fibrinolysis. 2013 Dec;24(8):862-8. doi: 10.1097/MBC.0b013e3283650cf9.
The objective of the present study was to investigate the efficacy of a four-factor prothrombin complex concentrate (Prothromplex, PTX) in shortening prolonged international normalized ratio or controlling life-threatening bleeding. The study was a retrospective single-centre study that included 142 patients treated with PTX and allocated in three groups: patients on vitamin K antagonists (VKA) (acenocumarol) and undergoing invasive procedure or presenting with severe bleeding (n = 76), patients treated with VKA presenting with intracranial haemorrhage (n = 22), and patients not on VKA and presenting with uncontrolled bleeding (n = 44). The primary outcome variable was international normalized ratio (INR) return to the norm after PTX infusion. Secondary outcome variables included bleeding control and reduction of transfusion rate. Overall, patients received a median of 1200 IU (≈15 IU/kg) of PTX, and INR decreased from 4 ± 3 to 1.7 ± 1.2 (P < 0.01) in all groups, although it remained at least 1.4 in 38% of patients (29.3% among patients receiving 25 IU/kg vs. 42.6% among those receiving 15 IU/kg; P < 0.05). Patients with initial INR at least 4 benefited the most from treatment. After PTX administration, there was a significant reduction in both transfused blood components units (P < 0.01) and estimated blood loss volume (from 1500 ± 1500 to 200 ± 100 ml; P < 0.01), and only one episode of deep venous thrombosis was observed. Administration of fixed doses of PTX shortened prolonged international normalized ratio and improved life-threatening bleeding in patients with or without VKA therapy. Higher dose attained a more adequate post-infusion INR.
本研究的目的是调查四因子凝血酶原复合物浓缩剂（Prothromplex，PTX）在缩短延长的国际标准化比值或控制危及生命的出血方面的疗效。该研究是一项回顾性单中心研究，纳入了142例接受PTX治疗的患者，并分为三组：接受维生素K拮抗剂（VKA）（醋硝香豆素）治疗且正在接受侵入性操作或出现严重出血的患者（n = 76），接受VKA治疗且出现颅内出血的患者（n = 22），以及未接受VKA治疗且出现出血无法控制的患者（n = 44）。主要结局变量是PTX输注后国际标准化比值（INR）恢复正常。次要结局变量包括出血控制和输血率降低。总体而言，患者接受PTX的中位数剂量为1200 IU（≈15 IU/kg），所有组的INR从4±3降至1.7±1.2（P < 0.01），尽管38%的患者INR仍至少为1.4（接受25 IU/kg的患者中为29.3%，接受15 IU/kg的患者中为42.6%；P < 0.05）。初始INR至少为4的患者从治疗中获益最大。PTX给药后，输注的血液成分单位（P < 0.01）和估计失血量（从1500±1500降至200±100 ml；P < 0.01）均显著减少，仅观察到1例深静脉血栓形成。给予固定剂量的PTX可缩短延长的国际标准化比值，并改善接受或未接受VKA治疗患者的危及生命的出血情况。较高剂量可使输注后INR更接近理想水平。
