Safety and patient acceptability of intravenous immune globulin in 10% maltose.

Journal Article (Clinical Trial;Journal Article)

The safety and patient acceptance of two preparations of modified (reduced and alkylated) immune globulin for intravenous use were evaluated; one preparation was formulated as a 5% solution in 10% maltose (IGIV-maltose), the other did not contain maltose (IGIV). In this double-blind trial each of 29 immunodeficient patients received three consecutive monthly infusions (100 or 150 mg/kg immune globulin) of one preparation before being crossed over to the other. Only 3 of 29 patients had adverse reactions when on IGIV-maltose, compared with 22 who had side-effects during infusions of IGIV (p < 0.001). Adverse reactions were recorded during 3 of 87 IGIV-maltose infusions and during 51 infusions with the maltose-free IGIV (p < 0.001). 27 patients expressed preference for IGIV-maltose. IGIV-maltose seems safe and will permit rapid infusion of large doses of immune globulin, thus improving the management of patients with antibody deficiency diseases.

Full Text

Duke Authors

Cited Authors

  • Ochs, HD; Buckley, RH; Pirofsky, B; Fischer, SH; Rousell, RH; Anderson, CJ; Wedgwood, RJ

Published Date

  • November 29, 1980

Published In

Volume / Issue

  • 2 / 8205

Start / End Page

  • 1158 - 1159

PubMed ID

  • 6107768

International Standard Serial Number (ISSN)

  • 0140-6736

Digital Object Identifier (DOI)

  • 10.1016/s0140-6736(80)92594-5

Language

  • eng

Conference Location

  • England