[Tolerability and pharmacokinetics of an intravenous immunoglobulin preparation in immunologically normal subjects and tolerability in patients with hypogammaglobulinemia resulting from chronic lymphatic leukemia].
Tolerance, clinical effects and kinetics of an unmodified immunoglobulin preparation for intravenous use were investigated in 4 patients with advanced chronic lymphocytic leukemia. Previously, good tolerance of the preparation had been found in 49 immunologically normal patients. The four patients with secondary humoral immunodeficiency received doses of 140-360 mg IgG/kg per infusion as outpatients at monthly intervals. With one exception, no acute infections (pneumonitis), as commonly seen before, were observed during the observation time of 24 to 68 weeks, and the pre-existing chronic infections (bronchitis, sinusitis etc.) remained compensated without antibiotics. In all four patients tolerance of the preparation was good. In all cases of hypogammaglobulinemia a dose-dependent increase in the serum IgG concentration was observed immediately after the infusion. However, persistence of the serum IgG increase showed considerable interindividual differences. The half life of the tetanus and HBs antibodies (21.7 to 34.4 and 19.7 to 25.7 days respectively) found in 4 healthy volunteers is within the biological range. This indicates an unmodified structure of the antibodies of the IgG class contained in the preparation used.