IMMUNOGLOBULIN-G SUBCLASS DISTRIBUTION IN 3 HUMAN INTRAVENOUS IMMUNOGLOBULIN PREPARATIONS
IMMUNOGLOBULIN-G SUBCLASS DISTRIBUTION IN 3 HUMAN INTRAVENOUS IMMUNOGLOBULIN PREPARATIONS
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DOI：
10.1111/j.1423-0410.1989.tb04976.x
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发表时间：
1989-01-01
期刊：
影响因子：
2.7
通讯作者：
HEINIGER, HJ
中科院分区：
文献类型：
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作者：
BURCKHARDT, JJ;GARDI, A;HEINIGER, HJ
在免疫缺陷患者中，免疫球蛋白（IG）的缺乏可以是全部或部分的，特异性IgG亚类失衡被总IgG的正常值所掩盖。在后一种情况下，静脉注射IgG制剂（IVIG）治疗通常是有益的，前提是所用的IVIG制剂来自大量正常献血者，并表现出正常的IgG亚类分布。我们分析了三种IVIG产品的亚类分布：Sandoglobulin（SAGL），Gamimune N（GI），Gammagard（GG），每个产品6-10个批次，在四个不同的实验室。竞争性酶免疫测定法和放射免疫扩散法分别使用对IgG 1、IgG 2、IgG 3和IgG 4具有特异性的不同单克隆和多克隆抗体。尽管实验室间存在微小差异，但结果表明，SAGL与GI和GG相比，IgG 1含量略低，但IgG 2比例较高，IgG 3水平无差异，但一种制剂（SAGL）含有2-3%的IgG 4，而GI为0.5-1.5%，GG低于0.5%。这种差异是显著的，后两种制剂处于或低于成人正常值的下限。这种差异可能具有重要的临床后果。
In immunodeficiency patients the lack of immunoglobulins (Ig) can be total or partial with a specific IgG subclass imbalance masked by normal values for total IgG. In the latter case therapy with intravenous IgG preparations (IVIG) is generally beneficial, provided the IVIG preparations used originate from large pools of normal blood donors and exhibit a normal IgG subclass distribution. We have analyzed the subclass distribution of three IVIG products: Sandoglobulin (SAGL), Gamimune N (GI), Gammagard (GG), 6-10 lots each, in four different laboratories. The competitive enzyme immunoassays and radial immunodiffusion methods used different monoclonal and polyclonal antibodies specific for IgG1, IgG2, IgG3, and IgG4, respectively. Despite minor interlaboratory differences, the results show that the slightly lower IgG1 content of SAGL versus GI and GG was quantitatively compensated by a higher proportion of IgG2, that no differences existed in IgG3 levels, but that one preparation (SAGL) contained 2-3% of IgG4 compared to 0.5-1.5% in GI and below 0.5% in GG. This difference was significant, the two latter preparations being at or below the lower limit of what are considered to be normal values found in human adults. Such differences may have important clinical consequences.