A DOSE-RESPONSE STUDY ON THE THERAPEUTIC EFFECT ON ACUTE SIMPLE CYSTITIS IN WOMEN: EXAMINATION OF MILOXACIN

Abstract

A dose-response study on therapeutic effect of miloxacin (MLX) on acute simple cystitis in women was performed by a double-blind method.
(1) Overall clinical efficacy (effective rate) was 89.2. 81.8, 74.4 and 42.1% in groups administered 1, 000, 500, 250 and 125 mg/day (q. i. d.) of MLX, respectively. When compared among the cases caused by gram-negative rods, the group administered 1, 000 mg/day of MLX showed a significantly higher overall clinical efficacy than other three groups. It was, therefore, assumed that the appropriate dosage of MLX for clinical use was 1, 000 mg/day.
(2) After the oral administration of MLX at the doses of 250, 125, 62.5 and 31.25 mg, the mean concentrations of the drug in urine (urine volume was corrected to 1 ml/min) ranged 12.6-23.8, 3.5-8.4, 3.1-5.7 and 0.8-2.3μg/ml, repectively. A curve was prepared by plotting the drug concentration in urine against the efficacy on bacteriuria at each dosage group. It was found that this curve was similar to the cumulative MIC curve against the bacteria isolated from urine of the patients of this study. When the MIC cumulative curve was shifted to the higher concentration by two tubes, these two lines fitted each other almost well. In other words, it was indicated that, multiplying the MIC values by a certain coefficiency, the cumulative MIC curve against urinary isolates was coincided with the curve obtained by plotting the drug concentration in urine against the effective rate.