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在40例甲型血友病病人接受家庭输注重组因子Ⅷ(rFⅧ)制剂Kogenate 1年,证明该制剂的安全性和有效性之后,从1989年1月开始,开展了一项用Kogenate处理以前未经治疗的甲型血友病病人(PUPs)的国际多中心临床试验。被研究的PUPs自首次接受Kogenate起每3个月用标准技术采集血液样本,用以检测FⅧ抑制物.检测采用Bethesda法。被检血液样本≥0.6Bethesda单位(BU),判为阳性;其样本还须做进一步试验,诸如其抗体的重、轻链特异性,FⅧ基因分析等。至今,已有66例PUPs和2例以前只经过最低
After 40 patients with hemophilia A received Kogenate for 1 year as a recombinant factor Ⅷ (rFⅧ) infusion formulation to prove the safety and efficacy of the preparation, starting from January 1989, a previous treatment with Kogenate International multicenter clinical trial of untreated hemophilia A (PUPs). The studied PUPs collected blood samples every 3 months from the first dose of Kogenate for the detection of FⅧ inhibitors using the Bethesda method. Blood samples were tested ≥ 0.6 Bethesda units (BU), sentenced to be positive; its samples also need to be further tested, such as its antibody weight, light chain specificity, F Ⅷ gene analysis. So far, 66 cases of PUPs and 2 cases have only been the lowest before