A comparative study on lomefloxacin and norfloxacin in the treatment of acute uncomplicated cystitis
Ohmori, H.; Kumon, H.; Suzuki, K.; Kamidono, S.; Arakawa, S.; Ishigami, J.; Tanaka, H.; Amano, M.; Fujita, Y.; Kanemasa, Y.
Japanese Journal of Antibiotics 42(4): 1025-1050
1989
ISSN/ISBN: 0368-2781 PMID: 2671424 Document Number: 334707
To objectively evaluate the efficacy, safety and utility of lomefloxacin (NY-198), a new quinolone antibacterial agent, in the treatment of acute uncomplicated cystitis, a comparative double blind trial was performed using norfloxacin (NFLX) as the control drug. In both groups, the drug was orally administered after meals for 3 days in a dose of 100 mg t.i.d. and clinical efficacies were assessed on the 3rd day (the 1st assessment) according to the criteria by the UTI Committee in Japan. Subsequently, either the active drug (NY-198 or NFLX) or placebo was administered for 4 days and the 2nd assessment was performed on the 7th day. Further, in patients who showed excellent responses at the 2nd assessment, recurrence was examined on the 14th day (the 3rd assessment) and on around the 21st day (the 4th assessment) following a subsequent 7-day placebo treatment. 1. A total of 258 patients was treated, and among them clinical efficacies were evaluable in 207 patients (NY-198; 106, NFLX:101) at the 1st assessment, and in 176 patients (NY-198-NY-198 which was the combination of the 1st and 2nd administrations: 47, NY-198-placebo: 43, NFLX-NFLX: 44, NFLX-placebo: 42). 2. In the evaluation of overall clincial efficacy by the committee at the 1st assessment, the overall efficacy rates in the NY-198 group and the NFLX group were 76.4% and 64.4% (excellent), respectively, or 100% and 99.0% (excellent and good), respectively. There was no statistically significant difference between the 2 groups. In the 1st assessment on effects of drugs on pain at micturition, pyuria and bacteriuria and on bacteriological response, no significant differences were observed between the 2 groups. 3. In the 2nd assessment by the committee, there were statistically significant differences among the 4 groups in the overall clinical efficacies and the effects on bacteriuria (P < 0.05). No difference was observed between NY-198 group and NFLX group, but the groups administered with active drug for 7 days, i.e. NY-198-NY-198 group and NFLX-NFLX group were significantly superior to the groups adminstered with active drug for 3 days and placebo for subsequent 4 days, i.e. NY-198-placebo group and NFLX-placebo group (P < 0.05). There were no differences in the effects on pain at micturition and pyruria among the 4 groups. 4. In the 1st assessment on clinical efficacy by doctors, the efficacy rates (excellent and good) in NY-198 group and NFLX group were 98.1% and 97.0%, respectively, showing no significant difference between the 2 groups. In the 2nd assessment, similarily, no differences were observed among the 4 groups. 5. Recurrence was examined in 89 cases at the 3rd assessment, and in 25 cases at the 4th assessment. In either of the assessments, there were no significant difference in recurrences rates among the 4 groups. 6. Side effects were observed in 6 of 127 cases (4.7%) in NY-198 group and in 3 of 123 cases (2.4%) in NFLX group. Abnormal laboratory test values were noted in 2 of 61 cases (3.3%) in NY-198 group. The difference between the 2 groups was not statistically significant. 7. In the utility evaluated by doctors at 1st and 2nd assessments, no significant differences were observed among the 2 and 4 groups, respectively. From these results, it was considered that NY-198 was a useful antibacterial agent in the treatment of acute uncomplicated cystitis.