Brummelhuis H G, Over J, Duivis-Vorst C C, Wilson-de Stürler L A, Ates G, Hoek P J, Reerink-Brongers E E
Vox Sang. 1983;45(3):205-16. doi: 10.1111/j.1423-0410.1983.tb01906.x.
Investigations were performed concerning the elimination of the risk of hepatitis B transmission of potentially infectious plasma derivatives by the addition of a low dose of hepatitis B immunoglobulin (HBIg). To this end, clotting factor VIII concentrate, prothrombin complex, C1 esterase inhibitor concentrate, plasminogen and antithrombin III were prepared from plasma strongly positive for hepatitis B surface antigen (HBsAg). To one half of every preparation, HBIg was added up to a final concentration of 0.4 IU anti-HBs/ml (test preparations), the other half was not treated (control preparations). Furthermore, to 10(-3) diluted infectious reference plasma (Bureau of Biologics, FDA, USA), an overdose HBIg was added to a final concentration of about 0.4 IU anti-HBs/ml. 6 chimpanzees, injected either with the control plasma derivatives or with the untreated infectious reference plasma, were infected with hepatitis B virus, whereas 5 chimpanzees, injected either with the test plasma derivatives or the infectious reference plasma to which the HBIg had been added, did not show any evidence of hepatitis B infection during the follow-up of 1 year. Addition of a low dose of HBIg to potentially infectious plasma derivatives appears to be a reliable measure to eliminate the hepatitis B transmission and is preferred to other methods for labile plasma derivatives.
针对通过添加低剂量乙肝免疫球蛋白（HBIg）消除潜在感染性血浆衍生物传播乙肝风险展开了研究。为此，从乙肝表面抗原（HBsAg）呈强阳性的血浆中制备了凝血因子VIII浓缩物、凝血酶原复合物、C1酯酶抑制剂浓缩物、纤溶酶原和抗凝血酶III。在每份制剂的一半中加入HBIg，使其最终浓度达到0.4 IU抗-HBs/ml（试验制剂），另一半不进行处理（对照制剂）。此外，在10⁻³稀释的传染性参考血浆（美国食品药品监督管理局生物制品局）中加入过量HBIg，使其最终浓度达到约0.4 IU抗-HBs/ml。给6只注射了对照血浆衍生物或未处理的传染性参考血浆的黑猩猩接种乙肝病毒，而在1年的随访期间，给5只注射了试验血浆衍生物或添加了HBIg的传染性参考血浆的黑猩猩未表现出任何乙肝感染的迹象。向潜在感染性血浆衍生物中添加低剂量HBIg似乎是消除乙肝传播的可靠措施，对于不稳定的血浆衍生物而言，该方法优于其他方法。
