複雑性尿路感染症に対するFosfomycin calciumの臨床評価 --二重盲検法によるCarbenicillin indanyl sodiumとの比較試験--

Abstract

A comparative double blind study was carried out in order to determine clinical effects, side effects and usefulness of fosfomycin calcium (FOM) in the treatment of complicated urinary tract infections, using carbenicillin indanyl sodium (ICBPC) as a control drug. The following results were obtained: 1. Out of all the 301 cases studied (151 cases from FOM group and 150 cases from ICBPC group), the therapeutic results could be evaluated with 267 cases (138 cases from FOM group and 129 cases from ICBPC group) and side effects were investigated with 296 cases (148 cases each from FOM and ICBPC groups). 2. Regarding background factors, no significant difference was found between the two groups. There was a statistically significant difference favouring FOM in the overall clinical efficacy, efficacy on pyuria, and partially in the improvement of symptoms, efficacy on bacteriuria compared to ICBPC. 3. Likewise according to physician's evaluation on the clinical efficacy and usefulness, there was a difference showing the superiority of FOM to ICBPC. 4. In view of the overall clinical efficacy in different type of infections classified by the UTI Study Group, FOM was found to be superior to ICBPC in the infections developed after prostatectomy and of the upper and the lower urinary tract infections without indwelling catheter. However, for the patients with mixed infections, there was no significant difference between two drugs. 5. Analysis of the bacteriological response by causative organisms revealed that the efficacy of FOM was superior to ICBPC against Serratia and E. coli, although there was no significant difference in the efficacy against Pseudomonas, Proteus and Klebsiella. 6. With respect to side effects and changes in laboratory findings, no significant difference was observed between FOM group and ICBPC group. Thus, FOM is an available drug in the therapy of complicated urinary tract infections.