In order to evaluate the effectiveness and safety of mezlocillin (MZPC), a multi clinical double blind comparative study against carbenicillin (CBPC) was conducted in patients with chronic complicated urinary tract infections. The patients were treated for 5 days with a dose of 2g b. i. d. of either MZPC or CBPC i. v. Total 203 patients were entered into the trial. Out of 203 cases, the comparison of the efficacy judged according to the criteria prepared by UTI Committee was made for 156 cases (MZPC; 81, CBPC; 75), whereas the comparison of the safety and utility judged by attending doctors was made for 200 cases (MZPC; 98, CBPC; 102), and of improvement judged also by attending doctors for 164 cases (MZPC; 84, CBPC; 80).
Having no significant differences in the various background factors of the patients between the MZPC and CBPC groups, the two groups were judged to be comparable.
Comparison between the two treatment groups was made in view of the over-all clinical efficacy, the efficacy on pyuria and bacteriuria, bacteriological responses, improvement of subjective symptoms, the final global improvement rate, usefulness, and occurrence of the adverse reactions to the drugs, and the following results were obtained.
1) In the comparison of the overall clinical efficacy, the MZPC treatment showed its efficacy rate of 37.0% and the CBPC treatment of 24.0%, indicating a trend of superiority of MZPC over CBPC.
In the comparison of the effect on bacteriuria, the elimination rate with MZPC was 25.9% while 13.3% with CBPC showing a tendency of superiority of MZPC. However, the trial showed a statistically significant superiority of the MZPC treatment to the CBPC treatment when elimination rate and decreasing rate are combined as well as when elimination rate, decreasing rate and also replacement rate are jointly judged.
2) Bacteriological responses,
i. e. elimination rate of isolated strains, were 58.0% with MZPC treatment and 41.69% with CBPC treatment. The difference between the two groups was statistically significant. When stratified with species of isolated strains, MZPC showed superior activity against
E. coil to that of CBPC.
3) In the final global improvement rating (FGIR), overall safety rating and usefulness judged by attending doctors, MZPC treatment showed a superior tendency to CBPC in the item of FGIR stratified by catheterization. There were no significant differences between the two treatment groups in the other categories.
4) Adverse reactions to the drugs were noted in 4.1% of the patients of the MZPC and in 4.9% the CBPC treatment.
Incidence rate of adverse reactions showed no significant difference between the two groups.
The aforementioned results justify to conclude that MZPC is a highly useful and safe drug for the treatment of chronic complicated urinary tract infections.
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