Therapeutic evaluation of combination therapy using C-425, human native immunoglobulin liquid preparation for i.v. administration, with antibiotics in severe infections in the field of internal medicine

Abstract

A novel human native immunoglobulin liquid preparation for intravenous injection, C-425, was used in combination with antibiotics to study its efficacy, safety, and usefulness in 262 patients with severe infections which had not responded to antibiotic therapy of 3-day or more duration. As a result of the Committee judgement, 12 of the 262 patients were excluded from this study; 87 were included only in safety analysis; 163 (62.2%) were included in efficacy, safety, and usefulness analyses (complete inclusion). The complete analysis of 163 patients consisted of 93 patients (57.1%) with suspected septicemia, 33 (20.2%) with pneumonia, and 18 (11.0%) with septicemia. Eighty percent or more of the patients had severe underlying diseases such as leukemia and malignant lymphoma. Clinical efficacy of C-425 was judged by the doctors in charge to be "excellent" or "good" in 49.1% of the total cases. The rate of effectiveness was calculated at 74.8% when "excellent", "good" and "fair" cases were all included. Similarly, the rate of effectiveness calculated from the results of Committee judgment was 53.4% when "excellent" and "good" cases were included, and 68.7% when "excellent", "good" and "fair" cases were included. Microbiological assessment was conducted in 19 patients. Causative organisms were eliminated in 11 patients, decreased in number in 1, persisted in 5, and replaced in 2. The rate of elimination was 57.9%. Side effects appeared in 6 of 250 patients (2.4%). It was judged that 3 patients (1.2%) of the 6 were affected by the drug or suspected to be affected, but they were not considered clinically important. Hepatic disfunction was found in 4 patients (1.6%) of the 250; but it was not clarified whether this was related to the drug. From these results, C-425 was considered to be an effective and very safe drug for treating severe internal infections.