Nicolaisen E M
Vessel Wall Biology, Health Care Discovery, Novo Nordisk, Gentofte, Denmark.
Blood Coagul Fibrinolysis. 1998 Mar;9 Suppl 1:S119-23.
Patients treated with activated recombinant factor VII (rFVIIa; NovoSeven, Novo Nordisk, Bagsvaerd, Denmark) were followed for potential antibody formation. The recombinant product was used to control serious and mild-to-moderate bleeds in a hospital environment and mild-to-moderate bleeds at home. The 267 patients included 222 haemophilia A patients, 16 haemophilia B patients, 16 non-haemophilia patients with inhibitors, and 13 factor VII (FVII)-deficient patients. The individual exposure ranged from one to 121 episodes treated over a period of up to 6 years. Analysis for FVII antibodies in an immunoassay revealed that pre-treatment samples from 5% of the haemophilia A patients had values above the normal range. None of these reactions were specific. Increased post-treatment values were observed in two FVII-deficient patients; both patients had been previously treated with plasma-derived FVII. The FVII-specific antibodies reacted equally well with plasma FVII and rFVIIa. The overall result from antibody determination shows no indication of antibody formation against rFVIIa in haemophilia A or B patients or in non-haemophilia patients with acquired inhibitors; however, FVII-deficient patients represent a risk group for development of antibodies against FVII.
对接受活化重组凝血因子VII（rFVIIa；诺和七，丹麦诺和诺德公司， Bagsvaerd）治疗的患者进行了随访，观察其是否可能形成抗体。该重组产品用于控制医院环境中的严重出血和轻至中度出血以及在家中的轻至中度出血。267例患者包括222例甲型血友病患者、16例乙型血友病患者、16例有抑制剂的非血友病患者和13例凝血因子VII（FVII）缺乏症患者。个体暴露时间长达6年，治疗次数从1次到121次不等。免疫分析检测FVII抗体发现，5%的甲型血友病患者治疗前样本的值高于正常范围。这些反应均无特异性。在两名FVII缺乏症患者中观察到治疗后值升高；这两名患者此前均接受过血浆源性FVII治疗。FVII特异性抗体与血浆FVII和rFVIIa的反应同样良好。抗体检测的总体结果显示，甲型或乙型血友病患者或获得性抑制剂的非血友病患者中没有迹象表明会形成针对rFVIIa的抗体；然而，FVII缺乏症患者是产生抗FVII抗体的风险群体。
