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经长期临床应用证明传统的因子Ⅷ(FⅧ)浓制剂疗效显著,已成为甲种血友病病人的主要治疗药物。但由于是从成千上万供血者混合血浆制备的,因而不可避免地存在若干潜在的不安全因素,如病毒污染及含有大量的同种抗原性蛋白。80年代FⅧ制剂的主要进展是成功地对制剂中的病毒进行灭活,以及开发了基本不含杂蛋白的高纯度FⅧ浓制剂。本文着重介绍传统制剂在临床应用中的潜在问题以及高纯度制剂的开发和初步临床应用情况。
After long-term clinical application of traditional factor Ⅷ (F Ⅷ) concentrated agents significant effect, has become the main treatment of hemophilia A patients. However, due to the mixed plasma preparation from thousands of blood donors, there are inevitably a number of potential unsafe factors, such as virus contamination and the presence of large amounts of homogenous antigenic proteins. The major advances of F VIII preparations in the 1980s were the successful inactivation of the virus in the preparations and the development of high purity FVIII concentrates that are essentially free of complex proteins. This article focuses on the potential problems of traditional formulation in clinical application and the development and preliminary clinical application of high purity formulation.