Weinkove R, Rangarajan S
Centre for Haemostasis and Thrombosis, St Thomas' Hospital, London, UK.
Transfus Med. 2008 Jun;18(3):151-7. doi: 10.1111/j.1365-3148.2008.00854.x.
This study aims to assess the efficacy and safety of fibrinogen concentrate in acquired hypofibrinogenaemic states. Cryoprecipitate is standard treatment for replacement of fibrinogen in acquired hypofibrinogenaemia. A virally inactivated fibrinogen concentrate (Haemocomplettan((R)); CSL Behring, Marburg, Germany) is licensed in some European countries. Clinical data for its use in acquired hypofibrinogenaemic states are scarce. Demographic and pretreatment clinical data of patients treated with fibrinogen concentrate for acquired hypofibrinogenaemia were retrospectively reviewed. Pretreatment and posttreatment fibrinogen levels, transfusion requirements, outcomes and adverse events were recorded. Thirty adult patients who received fibrinogen concentrate for acquired hypofibrinogenaemia (fibrinogen <1.5 g L(-1)) were included in the study. Causes of hypofibrinogenaemia included placental abruption, disseminated intravascular coagulation as a result of massive blood loss and transfusion, liver failure and cardiac surgery. Following a median dose of 4 g fibrinogen concentrate, median Clauss fibrinogen level rose from 0.65 to 2.01 g L(-1), with a median fibrinogen increment of 0.25 g L(-1) per 1 g fibrinogen concentrate administered. Forty-six per cent of patients stopped bleeding with blood components and fibrinogen concentrate alone, and a further 29% stopped bleeding with surgical or endoscopic intervention. Inpatient mortality was 40%. No venous thromboses were observed. Four patients with massive perioperative haemorrhage and hypotension (including three postcardiothoracic surgery) had arterial ischaemic events, none of which was attributable to fibrinogen overreplacement. The cost of fibrinogen concentrate was comparable with that of cryoprecipitate. Purified, virally inactivated fibrinogen concentrate appears effective in the management of acquired hypofibrinogenaemic states and enables rapid administration of a known fibrinogen dose in an emergency setting.
本研究旨在评估纤维蛋白原浓缩物在获得性低纤维蛋白原血症状态下的疗效和安全性。冷沉淀是获得性低纤维蛋白原血症中替代纤维蛋白原的标准治疗方法。一种病毒灭活的纤维蛋白原浓缩物(Haemocomplettan((R));德国马尔堡的CSL Behring公司)在一些欧洲国家已获许可。其用于获得性低纤维蛋白原血症状态的临床数据稀缺。对接受纤维蛋白原浓缩物治疗获得性低纤维蛋白原血症患者的人口统计学和治疗前临床数据进行了回顾性分析。记录了治疗前和治疗后的纤维蛋白原水平、输血需求、结局和不良事件。30例因获得性低纤维蛋白原血症(纤维蛋白原<1.5 g L(-1))接受纤维蛋白原浓缩物治疗的成年患者纳入研究。低纤维蛋白原血症的病因包括胎盘早剥、大量失血和输血导致的弥散性血管内凝血、肝衰竭和心脏手术。在给予中位剂量4 g纤维蛋白原浓缩物后,Clauss纤维蛋白原中位水平从0.65 g L(-1)升至2.01 g L(-1),每给予1 g纤维蛋白原浓缩物,纤维蛋白原中位增量为0.25 g L(-1)。46%的患者仅使用血液成分和纤维蛋白原浓缩物后出血停止,另有29%的患者通过手术或内镜干预后出血停止。住院死亡率为40%。未观察到静脉血栓形成。4例围手术期大出血和低血压患者(包括3例心胸外科手术后患者)发生了动脉缺血事件,均与纤维蛋白原过量替代无关。纤维蛋白原浓缩物的成本与冷沉淀相当。纯化的、病毒灭活的纤维蛋白原浓缩物在获得性低纤维蛋白原血症状态的管理中似乎有效,并且能够在紧急情况下快速给予已知剂量的纤维蛋白原。