In order to study the efficacy, safety and usefulness of apalcillin (APPC), a new synthetic penicillin, a comparative study was carried out by an envelope method on complicated urinary tract infections, using sulbenicillin (SBPC) as a control drug, and following results were obtained.
(1) Total number of 108 cases was treated with a daily dose of either 2g of APPC or 4g of SBPC y intravenous drip infusion for 5 days. The efficacy was evaluated according to the method by the U. T. I.-Committee in 101 cases out of 108 cases, consisting of 52 cases in the APPC-group and 49 cases in the SBPC-group. Seven cases were excluded and dropped out.
The clinical safety, was evaluated in 107 cases, consisting of 54 cases in the APPC-group and 53 cases in the SBPC-group.
The usefulness based on the results of the efficacy and safety of the drug was evaluated in 105 cases, consisting of 51 cases in the APPC-group and 54 cases in the SBPC-group.
(2) For the various background factors, there were no statistically significant differences between the APPC-group and the SBPC-group.
(3) There were no significant differences for the overall clinical efficacy, the efficacy on pyuria and bacteriuria, and appearance and replacement of strains isolated from urine after the treatment. As for the bacteriological response, the eradication rate against
Escherichia coli was significantly higher in the APPC-group than the SBPC-group (P<O. 05). While the eradication rate against such as
Klebsiella, Proteus, Pseudomonas tended to be higher in the APPC-group than the SBPC-group, any significant differences were not observed.
On the other hand, significant improvement of fever was noted in the SBPC-group in comparison with the APPC-group.
(4) There were no significant differences between 2 groups in the efficacy rate by the presence of catheterization, severity of pyuria, and the type and site of infections etc. before the treatment. (5) There were also no significant differences between 2 groups in the results of the evaluation for the usefulness.
(6) The incidence of side effects was 3. 7% and 7. 5% in the APPC-group and SBPC-group respectively, but no significant differences were found between them. In both 2 groups. slight and transient elevation of serum transaminase was observed in some cases during the treatment, but discontinuation of the drugs was not necessary at all.
(7) By above mentioned results, it was suggested that APPC is effective on chronic complicated urinary tract infections and less incident of side effect, and therefor it is clinically useful drug in this field.
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