Comparative double-blind trial of sisomicin and gentamicin in the treatment of complicated urinary tract infbctions

Abstract

With the purpose of evaluating the clinical efficacy, side effects and usefulness of sisomicin (SISO) objectively, a double-blind study was performed in complicated urinary tract infections, using gentamicin (GM) as the control drug, and the results obtained are summarized as follows:
1. From a total 211 cases, 6 cases were excluded from all analysis, and 39 cases partially excluded while 166 cases were evaluated with regard to clinical efficacy and usefulness of SISO and GM. Side effects were assessed in 205 cases, including the partial exclusion.
2. In the background characteristics bf the evaluated cases (82 SISO-treated cases and 84 GMtreated cases), no significant differences were noted between both treatment groups.
3. In regard to the clinical efficacy, the cure rate (“excellent” and “good” cases according to the criteria determined by the subcommittee of the research group) in the SISO group and GM group was 46.3% and 59.5%, respectively, with no significant differences between both groups.
4. According to the evaluation on usefulness by the physicians in charge, both drugs were determined to be “very useful” or “useful” in more than 60% of cases. Noticeably, SISO was significantly useful in the cases with complicated pyelonephritis, and GM chronic complicated cystitis.
5. In regard to the bacteriological response, GM was significantly effective, as compared with SISO, by both the overall analysis on total cases and in some items by stratified analysis.
The result of the analysis on eradication/persistence of each clinical isolate, including those from mixed infections, was that the SISO group showed a slightly higher eradication rate in Pseudomonas aeruginosa and the GM group in Serratia. However, both drugs showed comparable results when all the Gram-negative bacilli were analyzed together.
6. In regard to the improvement rate of pyuria and pyrexia, there were no significant differences between both treatment groups. As to lumbago and vesical symptoms, SISO group had a significantly higher improvement rate than the GM group.
7. Side effects and abnormal laboratory findings occurred at a low frequency in both treatment groups, and there were no significant differences between both drugs.
8. It is suggested that.SISO has an equivalent efficacy to GM. in the treatment of complicated urinary tract infections.