Safety of intravenous immunoglobulin preparations: a prospective multicenter study to exclude the risk of non-A, non-B hepatitis.

Abstract:

:The risk of non-A, non-B hepatitis transmission by an intravenous immunoglobulin (IVIG) preparation was assessed in a prospective multicenter trial in 68 patients with primary immunodeficiency disorders (40 children or adolescents and 28 adults). During the 4-week prestudy evaluation period the clinical examinations and liver function tests including alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, and bilirubin were normal in all patients. The treatment consisted of three infusions of 200 mg IVIG (pH 4; pepsin procedure) per kilogram body weight at 2-week intervals. During the observation period of 24 weeks following the first infusion of the study IVIG, the patients were monitored at regular time intervals. No clinical and laboratory signs of hepatitis or liver dysfunction were noticed. All patients completed the study. In 5 patients, one isolated alanine aminotransferase value and in another patient one gamma-glutamyl transpeptidase value were moderately elevated, but always below 2.5 times the upper limit of the reference range. Similar isolated and transient elevations were observed for aspartate aminotransferase and alkaline phosphatase. It was concluded that the IVIG preparation did not transmit non-A, non-B hepatitis or other viral liver diseases.

journal_name

Vox Sang

journal_title

Vox sanguinis

authors

Imbach P,Perret BA,Babington R,Kaminski K,Morell A,Heiniger HJ

doi

10.1111/j.1423-0410.1991.tb00953.x

subject

Has Abstract

pub_date

1991-01-01 00:00:00

pages

240-3

issue

4

eissn

0042-9007

issn

1423-0410

journal_volume

61

pub_type

临床试验,杂志文章,多中心研究
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    pub_type: 杂志文章

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    pub_type: 杂志文章

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    journal_title:Vox sanguinis

    pub_type: 杂志文章

    doi:10.1111/j.1423-0410.1987.tb04915.x

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    pub_type: 杂志文章

    doi:10.1111/j.1423-0410.1993.tb02511.x

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    pub_type: 杂志文章

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    更新日期:1985-01-01 00:00:00

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    pub_type: 杂志文章,评审

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    pub_type: 杂志文章

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    更新日期:2003-01-01 00:00:00

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    pub_type: 杂志文章

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    pub_type: 临床试验,杂志文章,随机对照试验

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    更新日期:1999-01-01 00:00:00

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