Fuhge P, Gratz P, Geiger H
Behring Inst Mitt. 1986 Feb(79):165-76.
In a modern therapy concept coagulation factor concentrates are widely used for prophylaxis of bleeding events and in intensive care medicine. In the past their use was limited by the risk of transmitting virus diseases to the patient. Therefore, it was a challenge to modern plasma fractionation to develop purification processes which are able to eliminate and inactivate viruses. At present several methods for virus inactivation are used; their efficiency is not finally proven. Practical experience exists with a method in which viruses are inactivated by heat treatment in solution. A similar process is used since more than 40 years to produce albumin and was proven to be safe. Today, all coagulation factor preparations can be treated by this inactivation method and produced in large scale. Together with a high degree of viruses elimination during the purification process the therapy with coagulation factors has become much safer.
在现代治疗理念中，凝血因子浓缩剂广泛用于预防出血事件以及重症监护医学领域。过去，其使用受到将病毒疾病传播给患者风险的限制。因此，开发能够消除和灭活病毒的纯化工艺对现代血浆分馏来说是一项挑战。目前使用了几种病毒灭活方法；但其有效性尚未得到最终证实。有一种在溶液中通过热处理灭活病毒的方法有实际应用经验。一种类似的工艺已用于生产白蛋白40多年，且被证明是安全的。如今，所有凝血因子制剂都可以通过这种灭活方法进行处理并大规模生产。再加上在纯化过程中高度去除病毒，凝血因子治疗已变得安全得多。
