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 Surgery

Abstract

In a nationwide study conducted in 11 surgical institutions of C-425, a newly developed human native immunoglobulin liquid preparation for intravenous injection, was combinedwith conventional antibiotic treatment to investigate the efficacy and safety. A total of 47 patients with severe infections which had not symptomatically responded to 3-day or longer treatment with any antibiotics was included.
Doctors in charge judged the efficacy of C-425 to be “excellent” in 3 patients, “good” in 13, “fair” in 15, and “poor” in 4. Thus, a total of 16 patients (45.7%) was judged to have responded to C-425 when the “excellent” and “good” responses were combined. The number responding was 31 (88.6%) when the “fair” cases were also included.
Excluding 31 patients who did not meet the Committee's criteria, the Committee judged the efficacy of C-425 in a total of 16 patients; the efficacy was “excellent” in 2 patients, “good” in 4, “fair” in 9, and “poor” in 1.The number of responding patients was 6 (37.5%) of the 16 when the “excellent” and “good” cases were combined, and 15 (93.8%) when the “fair” cases were added.
Bacteriological assessment was conducted in a total of 9 patients. Causative bacteria were eradicated in 3 patients, decreased in number in 1, replaced in 2, and persisted in 3. Thus, bacteriological efficacy was observed in 6 of the 9 patients (66.7%).
Neither adverse reactions nor drug-related laboratory abnormalities were observed in the 47 patients.