Martinowitz U
National Hemophilia Center, Chaim Sheba Hospital, Tel-Hashomer, Israel.
Blood Coagul Fibrinolysis. 1995 Jul;6 Suppl 2:S84-5.
The incorporation of viral inactivation steps into the manufacture of factor VIII concentrates has markedly improved the safety margin of the product, but in order that viruses, such as hepatitis A, are not transmitted by infusion of factor VIII preparation, some manufacturers include a further process step, such as heat inactivation. There is the possibility that such a step will change the final factor VIII product and it was investigated whether there are any pharmacokinetic differences between the products Octavi S/D and Octavi S/D+heat treatment. It is concluded that Octavi S/D+heat treatment can be given in doses equal to Octavi S/D or other factor VIII concentrates.
将病毒灭活步骤纳入凝血因子 VIII 浓缩物的生产过程，显著提高了产品的安全系数。但为了确保甲型肝炎等病毒不会通过输注凝血因子 VIII 制剂传播，一些制造商增加了进一步的工艺步骤，如热灭活。这样的步骤有可能改变最终的凝血因子 VIII 产品，因此对 Octavi S/D 产品和经过热灭活处理的 Octavi S/D 产品之间是否存在药代动力学差异进行了研究。得出的结论是，经过热灭活处理的 Octavi S/D 产品可以给予与 Octavi S/D 或其他凝血因子 VIII 浓缩物相同的剂量。
