[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].
In a nationwide study conducted in 11 surgical institutions of C-425, a newly developed human native immunoglobulin liquid preparation for intravenous injection, was combined with 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.
Second Department of Surgery, Tokyo Medical and Dental University of Medicine.
Y
Y
Mishima
T
T
Inoue
H
H
Hayasaka
M
M
Totsuka
T
T
Ebata
R
R
Motoki
H
H
Inoue
Y
Y
Endo
S
S
Tamakuma
J
J
Imai
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001424:Bacterial Infections / Q000628:therapy*; D004359:Drug Therapy, Combination / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage*; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009369:Neoplasms / Q000150:complications / Q000601:surgery; D010532:Peritoneal Diseases / Q000628:therapy; D012141:Respiratory Tract Infections / Q000628:therapy; D014552:Urinary Tract Infections / Q000628:therapy
D000900:Anti-Bacterial Agents; D007074:Immunoglobulin G