Cinoxacin was employed to treat women diagnosed as having acute simple cystitis. The therapeutic efficacy was investigated not simply in terms of the cure rate during the treatment period. but also in terms of the recurrence rate during the one week following the completion of the antibiotic administration. In this way, an investigation was made of the degree of sufficiency of the curative effect provided by the cinoxacin therapy.
The patients were female cases of acute simple cystitis which fulfilled the UTI criteria. These patients were divided into four groups on the basis of the daily dosage of cinoxacin that was administered: 800mg, 400mg, 200mg and 100mg (all of these dosages were divided into two doses); the treatment period with each of these dosages was 3 days. A total of 138 patients were evaluated as showing excellent clinical efficacy at the time of completion of the treatment. These patients were administered a placebo for an additional 7 days, and then they were investigated for any recurrence of the inflammatory symptoms. This investigation was carried out as a comparative study by the double-blind method.
(1) A total of 82 patients were investigated for recurrence of the inflammation; recurrence was judged to be positive in 22 of these patients, for a recurrence rate of 26.8%. There were no significant differences seen between the recurrence rates recorded for the four cinoxacin dosage groups.
(2) The cases of recurrence were judged to be cases of reinfection when either the species of the bacterium or the serotype of
E. coli isolate at that point was different from that of the bacterium isolated prior to the cinoxacin treatment. Only when the species at the time of recurrence was the same as that of the initially-isolated species, was the recurrence judged to be a case of relapse. Calculation of the reinfection rate and the relapse rate gave values of 8.5% (7/82) and 18.3% (15/82), respectively. The relapse rates as a function of the dosage group showed the following values: 8.0 in the 800 mg group, 17.6% in the 400mg group, 26.1% in the 200mg group and 23.5% in the 100mg group. Thus, it is seen that the relapse rate was somewhat lower in the 800 mg administration group. No clear differences were seen between the rates of reinfection for the four cinoxacin dosage groups.
(3) The bacteria that were isolated following the recurrence were found to show MICs that mostly fell within the range of 1.56 to 3.13μg/ml. This distribution was very similar to the distribution shown by the bacteria that were isolated prior to the cinoxacin therapy.
(4) No correlation was found to exist between the recurrence rate and the bacterial count at the time that the cinoxacin therapy was started.
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