Hoppe I
Blut. 1979 Jul;39(1):9-16. doi: 10.1007/BF01008070.
A great number of commercially available immunoglobulins was screened for erythrocyte-, HLA- and autoantibodies. Isoagglutinin titers were in general low, hemolysins were not detected. No preparation was found to contain detectable amounts of autoantibodies versus nuclei, mitochondria, smooth muscle or parietal cells. Yet 7 out of 22 immunoglobulin charges contained irregular red cell antibodies, aside of polyspecific albumin reactive types in 5 cases a distinct anti-D. Only the preparation examined in 1975 contained polyspecific HLA-antibodies. 1977/78 all preparations for intravenous use were free from undesired antibodies, while those for intramuscular application were contaminated with irregular red cell antibodies 1975 as well as 1978. Because of their low strength these antibodies imply no clinical risk. Nonetheless an improvement of the official rules for the production and control of immunoglobulin preparations is inevitable to avoid damage caused by exceptional charges with extremely strong antibodies of this type.
对大量市售免疫球蛋白进行了红细胞、HLA和自身抗体筛查。同种凝集素滴度一般较低,未检测到溶血素。未发现任何制剂含有可检测量的针对细胞核、线粒体、平滑肌或壁细胞的自身抗体。然而,在22批免疫球蛋白中,有7批含有不规则红细胞抗体,5例除多特异性白蛋白反应型外还含有明显的抗-D抗体。仅1975年检测的制剂含有多特异性HLA抗体。1977/1978年,所有静脉用制剂均无不良抗体,而1975年和1978年的肌内用制剂则被不规则红细胞抗体污染。由于这些抗体效价低,不具有临床风险。尽管如此,为避免因极少数含有此类极强抗体的批次造成损害,改进免疫球蛋白制剂生产和控制的官方规定势在必行。