Clinical trials of sulfonated immunoglobulin preparation for intravenous administration

✍ Scribed by S. Matsumoto; N. Kobayashi; N. Gohya

• Publisher: Springer
• Year: 1981
• Tongue: English
• Weight: 476 KB
• Volume: 136
• Category: Article
• ISSN: 0340-6997
• DOI: 10.1007/bf00441919

✦ Synopsis

Physicians have long wished for a preparation for intravenous administration which has the functions of native 7-globulin molecules but which has minimal untoward effects. S-sulfonated ?,-globulin (GGS) is a preparation which satisfies these requirements, and its intravenous administration results in all of the expected Fc activities.

Anticomplementary activity of GGS in the sera of various patients in vitro has indicated an extremely low level of2-11%. With this in mind, a comparison of the clinical adverse effects of GGS was made in three groups: group A with infections having no underlying disease; group B with malignancies; and group C with immunodeficiencies.

GGS was administered 1,076 times to a total of 567 patients. The incidence of side effects was 0.8% in patients of group A; 1.5% in the group B patients; and 14.6% in group C patients. In group C the rate of adverse reactions to the number of administrations was 3.9%.

The adverse reactions were mainly minor, i.e., vasomotor symptoms, transient shock-like symptoms, and pyrexia appeared in some cases. In most cases there were no side reactions even in patients given repeated doses of GGS, and the number of cases classified as highly susceptible to adverse reactions was very small. The incidence of side effects was in inverse proportion to age, and the most hazardous symptoms appeared in patients with severe combined immunodeficiencies. The side reactions appeared within 30 min of GGS administration, with the exception of the febrile responses.

* Corresponding author

The above results indicated that the incidence of side reactions to GGS was not greater than that observed with conventional intravenous preparations of y-globulin. However, precautions must be taken in the use of GGS for replacement therapy in patients with immunodeficiencies.