二重盲検法によるTobramycinとGentamicinの尿路感染症に対する薬効比較

Abstract

In order to examine its effectiveness and safety, tobramycin was studied in urinary tract infections by the double blind comparative method using gentamicin as the control drug. Tobramycin or gentamicin was administered to hospitalized adult patients with urinary tract infections (cystitis or pyelonephritis) at the dosage of 60mg b.i.d. for five to seven days. The number of evaluable cases was 86 for tobramycin and 95 for gentamicin, and the results obtained were as follows. (1) No significant difference was observed between the tobramycin group and gentamicin group in various background factors related to the characteristics of patients. (2) There was no significant difference between the two groups in overall efficacy (tobramycin 69%, gentamicin 69%). (3) Analyses were made as to various clinical parameters. In overall analyses, no significant difference was observed between the two groups in the improvement rate of any parameters. In stratified analyses, tobramycin showed a significantly better rate of defervescence than gentamicin in patients with complicated pyelonephritis without an indwelling catheter. In the analysis of the distribution of body temperature, tobramycin showed a significantly better result than gentamicin on Day 3 in all patients, patients with complicated pyelonephritis and patients with an indwelling catheter. In urinary bacterial counts, gentamicin showed significantly better result than tobramycin on Day 6 in patients without an indwelling catheter. In urinary leukocyte counts, tobramycin showed a tendency for better results than gentamicin on Day 6 in patients with complicated pyelonephritis. (4) No difference was observed between the two groups in the incidence of reported adverse effects (tobramycin 18.6%, gentamicin 19.4%).