Hilfenhaus J, Weidmann E
Arzneimittelforschung. 1986 Apr;36(4):621-5.
Heat treatment at 60 degrees C for 10 h in solution (pasteurization) was introduced into the manufacturing process of factor VIII concentrate (Haemate P) in order to considerably reduce the risk of transmission of human pathogenic viruses to haemophiliacs. The results of experimental and clinical studies with regard to hepatitis B, non-A, non-B hepatitis, acquired immune deficiency syndrome (AIDS) and herpes virus infections are reviewed. From this data it is concluded that pasteurization of factor VIII results in a product which is safe with regard to these viral infections. Furthermore, it was shown that pasteurization does not form new antigenic determinants on the factor VIII molecule and compared with the native product does not alter the physiological properties of this protein in patients. In comparison to these advantageous properties of the pasteurized product a slight loss of coagulant activity seems to be acceptable. This loss of yield, however, does not influence the quality or the amount of factor VIII in the final container used for the therapy of haemophilia A patients.
为了大幅降低人类致病病毒传播给血友病患者的风险，在凝血因子VIII浓缩物（海莫莱士）的生产过程中引入了在溶液中60摄氏度加热10小时的热处理（巴氏消毒法）。本文回顾了关于乙型肝炎、非甲非乙型肝炎、获得性免疫缺陷综合征（艾滋病）和疱疹病毒感染的实验及临床研究结果。从这些数据可以得出结论，凝血因子VIII的巴氏消毒产生的产品在这些病毒感染方面是安全的。此外，研究表明巴氏消毒不会在凝血因子VIII分子上形成新的抗原决定簇，并且与天然产品相比，不会改变该蛋白质在患者体内的生理特性。与巴氏消毒产品的这些有利特性相比，凝血活性略有损失似乎是可以接受的。然而，这种产量损失并不影响用于治疗甲型血友病患者的最终容器中凝血因子VIII的质量或数量。
