A prospective controlled crossover trial of a new heat-treated intravenous immunoglobulin.

Abstract:

:Twenty-one patients with primary immunoglobulin deficiency were enrolled in a crossover study to test the efficacy and safety of Alphaglobin in comparison with the licensed preparations Sandoglobulin and Gamimune. There was no statistical difference in these parameters between Alphaglobin and Sandoglobulin/Gamimune. The level of total serum IgG and specific IgG to pneumococcal polysaccharides was similar in individual patients when they were receiving Alphaglobin or one of the other products. Transient increases in serum alanine transferase occurred in five patients on Sandoglobulin/Gamimune and two patients on Alphaglobin. Some patients showed a rise in total serum IgM afterwards, indicating a response to infection. However, serum hepatitis C virus (HCV) RNA was not found during the alanine transferase (ALT) rises, and IgM antibody to hepatitis A virus (HAV) was negative afterwards. We conclude that Alphaglobin is a safe, well tolerated and clinically efficacious treatment for patients with primary antibody deficiency.

journal_name

Clin Exp Immunol

authors

Zuhrie SR,Webster AD,Davies R,Fay AC,Wallington TB

doi

10.1111/j.1365-2249.1995.tb03465.x

subject

Has Abstract

pub_date

1995-01-01 00:00:00

pages

10-5

issue

1

eissn

0009-9104

issn

1365-2249

journal_volume

99

pub_type

临床试验,杂志文章
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    doi:

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    pub_type: 杂志文章,评审

    doi:

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