CLINICAL APPRAISAL OF OXACEPHEM ANTIBIOTIC “6059-S” IN COMPLICATED URINARY TRACT INFECTION

Compamtive Study with Sulbonioillin

Abstract

In order to evaluate objectively the clinical efficacy and side effects of a new oxacephem antibiotic “6059-S”, a well-controlled study was carried out using Sulbenicillin (SBPC) as a control drug in patients with complicated urinary tract infection. 1g of 6059-S or 5g of SBPC was injected intravenously (drip infusion) twice a day (2 g of 6059-S or 10g of SBPC per day) for consecutive 5 days. Both drugs were administered to 244 patients, and the clinical efficacies of 108 patients who were administered 6059-S and of 102 patients who were administered SBPC were able to be evaluated completely according to “Criteria for Evaluation of Efficacy of Antimicrobial Agents on Urinary Tract Infections”.
The overall effectiveness rate of 6059-S group with single infection was 77.5% (55/71 patients) and that of SBPC group was 52.7%(29/55 patients). This effectiveness rate of 6059-S group was significantly superior than that of SBPC group by statistical analysis. Concerning to mixed infection, the patients were separated into two groups, one group was the patients with indwelling catheter and another group was the patients without indwelling catheter. As to catheter indwelling group, the effectiveness rate of 6059-S group was 58.8% (10/17 patients), which was significantly superior than that of SBPC group (25.7%, 9/35 patients). As to the group without indwelling catheter, the effectiveness rate of 6059-S group was 70.0% (14/20 patients) and that of SBPC group was 83.3% (10/12 patients). There was no significant dierence between those effectiveness rates. Bacteriologically, the eradication rate of 6059-S group against E. coli was 95.5%, and 81.0% against S. marcescens and 78.6% even against Pseudomonas species. Against all species of bacteria except for S. faecalis, 6059-S was confirmed to show the excellent eradication rate.
The subjective side effects were observed in 0.8% (1/124 patients) of 6059-S group and in 2.5%(3/120 patients) of SBPC group, and deterioration in laboratory hematological test values were observed in 2.7% (3/113 patients) of 6059-S group and 3.6% (4/112 patients) of SBPC group. There were no significant dierence between the side effects of both groups of drug. All side effects were transient and not serious.
Based on the above results, 6059-S was considered to be less toxic, safe and clinically extremely useful drug for the treatment of complicated urinary tract infections.