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

Lancet. 1980 Nov 29;2(8205):1158-9. doi: 10.1016/s0140-6736(80)92594-5.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Clinical Trials as Topic
  • Double-Blind Method
  • Excipients
  • Female
  • Humans
  • Immune Sera / administration & dosage*
  • Immunoglobulins / administration & dosage*
  • Immunologic Deficiency Syndromes / therapy*
  • Infusions, Parenteral / adverse effects
  • Male
  • Maltose*

Substances

  • Excipients
  • Immune Sera
  • Immunoglobulins
  • Maltose