[Tolerance of a new intravenously applied immunoglobulin preparation and its effect on serum globulin levels].
In a controlled prospective study, 212 patients were evaluated in 13 different hospitals with regard to the clinical tolerance of a new gammaglobulin preparation which can be administered intravenously. The age of the patients ranged from one day to 83 years. Patients with a primary or secondary immunoglobulin deficiency and patients with normal serum immunoglobulin concentrations were included in the study. In 811 infusions a total of 7128 g gammaglobulin were applied; the maximum dosage was 30 g/day. We saw a transient, recurrent and spontaneously reversible fever reaction in one patient with long-term substitution because of a primary immunodeficiency syndrome. Otherwise, no serious side-effects were seen in clinical or laboratory controls. Patients controlled for their serum gammaglobulin concentrations before and after the infusions showed a significant rise of 112.5 mg/100 ml for each infusion of 3 g gammaglobulin. The new preparation also showed an estimated half-life of 23 days, thus making it a good possibility for long-term substitution in immunodeficient patients.