Klamroth Robert, Gottstein Saskia, Orlovic Marija, Heinrichs Christl
Department of Internal Medicine - Angiology and Clotting Disorders, Haemophilia Treatment Centre, Vivantes Klinikum im Friedrichshain, Berlin, Germany.
Department of Internal Medicine - Angiology and Clotting Disorders, Haemophilia Treatment Centre, Vivantes Klinikum im Friedrichshain, Berlin, Germany.
Thromb Res. 2014 Nov;134 Suppl 1:S38-42. doi: 10.1016/j.thromres.2013.10.015. Epub 2013 Nov 17.
Beriate(®) P was first introduced in Germany in 1990 as factor VIII (FVIII):C(®) HS Behring and subsequent product improvements yielded an albumin-free formulation with a specific activity of approximately 170 IU/mg protein. In 1992, the concentration was raised to 100 IU FVIII/mL in the reconstituted product, with a mean specific activity of 270 IU/mg protein. Pathogen safety is achieved by careful donor selection and a combination of pasteurization and chromatographic purification steps.
We analysed the efficacy and safety of Beriate(®) P in the clinical setting from 1996 to 2005 with a focus on surgical patients. Of the 36 patients (mean age: 38 years; range 1-72 years), 29 had severe haemophilia A, two had moderate haemophilia, two had mild haemophilia, and three had sub-clinical haemophilia. Most patients (n=28) had more than 100 exposure days, representing a total of 202 patient-years with a consumption of 27,811,500 IU of Beriate(®) P.
There was no evidence of seroconversion towards relevant viruses, no inhibitor development (35 previously treated patients, one previously untreated patient), no abnormal immunological findings or allergic reactions. In all 36 patients treated for acute bleeding and prophylaxis, and 24 surgeries (15 total joint replacements, eight orthopaedic procedures, one cholecystectomy) in 16 patients with severe haemophilia A, efficacy of Beriate(®) P was always rated as "excellent" or "good", and no thrombosis was reported.
Beriate(®) P has an excellent efficacy and safety profile. Many patients who were initiated on Beriate(®) P at our centre remain on the treatment today.
贝瑞特（®）P于1990年首次在德国推出，当时名为凝血因子VIII（FVIII）：C（®）贝林，随后产品改进产生了一种无白蛋白配方，比活性约为170 IU/mg蛋白质。1992年，复溶产品中凝血因子VIII的浓度提高到100 IU/mL，平均比活性为270 IU/mg蛋白质。通过仔细筛选献血者以及结合巴氏消毒和色谱纯化步骤来实现病原体安全性。
我们分析了1996年至2005年期间贝瑞特（®）P在临床环境中的疗效和安全性，重点关注外科手术患者。36例患者（平均年龄：38岁；范围1 - 72岁）中，29例患有重度甲型血友病，2例患有中度血友病，2例患有轻度血友病，3例患有亚临床血友病。大多数患者（n = 28）暴露天数超过100天，总计202患者年，消耗了27,811,500 IU的贝瑞特（®）P。
没有证据表明出现针对相关病毒的血清转化，没有抑制剂产生（35例既往接受治疗的患者，1例既往未接受治疗的患者），没有异常免疫发现或过敏反应。在所有36例接受急性出血治疗和预防的患者以及16例重度甲型血友病患者中的24例手术（15例全关节置换、8例骨科手术、1例胆囊切除术）中，贝瑞特（®）P的疗效始终被评为“优秀”或“良好”，且未报告血栓形成。
贝瑞特（®）P具有出色的疗效和安全性。在我们中心开始使用贝瑞特（®）P治疗的许多患者至今仍在接受该治疗。
