Horowitz B
New York Blood Center, NY 10021.
Yale J Biol Med. 1990 Sep-Oct;63(5):361-9.
The well-documented viral safety of albumin arises from several factors operating in concert, including virus removal during preparation, immune neutralization, serendipitous inactivation, virus sterilization through pasteurization. Safety with respect to HBV transmission was achieved even prior to the development of sensitive screening tests for HBsAg, as can be predicted given the initial virus load and the influence of factors affecting removal and inactivation. Coagulation factor concentrates, as traditionally prepared, are known to have transmitted the viral agents of hepatitis and AIDS with high frequency. Application of virucidal procedures to these concentrates, in some cases, appears to have eliminated virus transmission, raising the question as to whether absolute safety has now been achieved. Clinical proof of absolute safety is made difficult by the small number of eligible patients who can be monitored, lengthy and expensive monitoring procedures, and opportunity for transmission of virus by product-independent routes. Based on viral load analysis, modern coagulation factor concentrates are predicted to have the same probability of freedom from HIV, HBV, and HCV transmission as that exhibited by albumin.
白蛋白良好的病毒安全性源于多种协同作用的因素，包括制备过程中的病毒去除、免疫中和、意外灭活、巴氏消毒法的病毒杀灭。甚至在开发出针对乙肝表面抗原（HBsAg）的敏感筛查试验之前，就已实现了乙肝病毒传播方面的安全性，鉴于初始病毒载量以及影响去除和灭活的因素的作用，这是可以预测的。传统制备的凝血因子浓缩物已知曾高频传播肝炎和艾滋病病毒病原体。在某些情况下，对这些浓缩物应用杀病毒程序似乎消除了病毒传播，这就引发了是否现已实现绝对安全的问题。由于可监测的合格患者数量少、监测程序冗长且昂贵以及存在通过与产品无关的途径传播病毒的可能性，绝对安全性的临床证据难以获得。基于病毒载量分析，预计现代凝血因子浓缩物与白蛋白一样，没有感染艾滋病毒、乙肝病毒和丙肝病毒的传播风险。
