Epstein J S, Fricke W A
Division of Blood and Blood Products, Food and Drug Administration, Bethesda, MD 20892.
Arch Pathol Lab Med. 1990 Mar;114(3):335-40.
Earlier commercial clotting factor concentrates transmitted hepatitis viruses to 100% and acquired immunodeficiency syndrome viruses to 60% to 80% of patients with hemophilia. Transmission of the human immunodeficiency virus was nearly eliminated by heating concentrates in the lyophilized state, which has been done since 1983. However, human immunodeficiency virus infections were still transmitted by some products "dry heated" under conditions less extreme than 68 degrees C for 72 hours. Newer virus-inactivating procedures include "dry heating" at 80 degrees C for 72 hours, modified heating in n-heptane or water vapor, heating in solution, treatment with solvent-detergent mixtures, monoclonal affinity purification plus inactivation, and alkylation with beta-propiolactone (only for factor IX complex). These procedures have eliminated significant loads of human immunodeficiency virus, hepatitis B virus, and non-A, non-B hepatitis virus in laboratory studies. However, clinical studies have shown transmission of hepatitis non-A, non-B for products "dry heated" except at 80 degrees C and for products heated in n-heptane. Elimination of hepatitis B has been difficult to demonstrate, suggesting a continued need for immunization.
早期的商业凝血因子浓缩剂会将肝炎病毒传播给100%的血友病患者，将获得性免疫缺陷综合征病毒传播给60%至80%的血友病患者。自1983年以来，通过对冻干状态的浓缩剂进行加热，人类免疫缺陷病毒的传播几乎得以消除。然而，一些产品在低于68摄氏度的条件下进行“干热”处理时，仍会传播人类免疫缺陷病毒感染。新的病毒灭活程序包括在80摄氏度下“干热”72小时、在正庚烷或水蒸气中进行改良加热、在溶液中加热、用溶剂 - 去污剂混合物处理、单克隆亲和纯化加灭活以及用β-丙内酯烷基化（仅用于因子IX复合物）。这些程序在实验室研究中已消除了大量的人类免疫缺陷病毒、乙型肝炎病毒和非甲非乙型肝炎病毒。然而，临床研究表明，除了在80摄氏度下进行“干热”处理的产品以及在正庚烷中加热的产品外，其他“干热”产品仍会传播非甲非乙型肝炎。乙型肝炎的消除很难得到证实，这表明仍需要持续进行免疫接种。
