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[静脉注射用特异性抗巨细胞病毒免疫球蛋白的制备]

[Preparation of a specific anti-cytomegalovirus immunoglobulin for intravenous injection].

作者信息

Maniez-Montreuil M, Dupressoir-Burlet M V, Martinache L, Goudemand M

出版信息

Rev Fr Transfus Immunohematol. 1984 Jun;27(3):375-82. doi: 10.1016/s0338-4535(84)80178-6.

Abstract

In the industrialised countries of Europe about 60-70% of adults possess antibodies against cytomegalovirus. Primary infections or exacerbations of a latent infection are in most cases clinically asymptomatic in healthy patients. By way of contrast, attenuations in the immunological defence system: prematureness, pregnancy, the presence of malignant disease, immunosuppressive therapy, as well as massive transfusions of blood, are the commonest causes of a raised incidence of CMV infections often combined with severe clinical overt illness. Because a critical level of antibody is needed to prevent infection and disseminating, we have produced cytomegalovirus hyperimmune globulin for intravenous administration. They are prepared from plasmas of healthy blood donors on the basis of a high antibody level against cytomegalovirus. About 6% are selected by an ELISA procedure. Immunoglobulins, treated to ensure excellent intravenous acceptability, are lyophilized. The final product is found to have an anti-CMV antibody titer of 25 600, by the ELISA test, at a protein concentration of 5%. This CMV-immunoglobulin I.V. has 8 fold higher antibody content than do conventional immunoglobulin preparations. The first trials of prophylaxis and treatment of clinically apparent CMV infections are under study.

摘要

在欧洲工业化国家,约60% - 70%的成年人拥有抗巨细胞病毒的抗体。在大多数情况下,原发性感染或潜伏感染的复发在健康患者中临床上无症状。相比之下,免疫防御系统的减弱:早产、妊娠、恶性疾病的存在、免疫抑制治疗以及大量输血,是巨细胞病毒感染发生率升高且常伴有严重临床显性疾病的最常见原因。由于需要临界水平的抗体来预防感染和传播,我们制备了用于静脉注射的巨细胞病毒超免疫球蛋白。它们是从健康献血者的血浆中制备的,基于针对巨细胞病毒的高抗体水平。约6%的血浆通过酶联免疫吸附测定(ELISA)程序筛选。经过处理以确保具有良好静脉内可接受性的免疫球蛋白被冻干。通过ELISA试验,最终产品在蛋白质浓度为5%时,抗巨细胞病毒抗体滴度为25600。这种静脉注射用巨细胞病毒免疫球蛋白的抗体含量比传统免疫球蛋白制剂高8倍。对临床上明显的巨细胞病毒感染进行预防和治疗的首批试验正在研究中。

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