To evaluate objectively the clinical efficacy and cure rate of gatifloxacin (GFLX), 8-methoxyquinolone derivatives, in the 3-day and 7-day treatment of female acute uncomplicated cystitis, we performed a randomized double-blind comparative study. Only female patients with pain on micturition, pyuria of at least 10 WBCs/hpf and bacteriuria of at least 104 CFU/mL were admitted to this study. Ninety-nine patients were randomly assigned to receive 100 mg b.i.d. of GFLX for 3 days (group A) and 7 days (group B). The clinical efficacy was assessed on Day 7 and follow-up examinations were carried out on Day 14 and Day 35. 1. Using the criteria of the Japanese UTI Committee, clinical efficacy on Day 7 was evaluated in 34 patients in group A and 37 patients in group B. In this two groups, there were no significant differences in background characteristics of patients. 2. The overall clinical efficacy rate (excellent and moderate responses) was 97.1% in group A and 100 % in group B, with no significant difference. The bacterial eradication rate was 97.1% of 35 strains in group A and 100% of 37 strains in group B, with no significant difference. The clinical efficacy rate as assessed by the doctor in charge was 97.1% in group A and 94.6% in group B, and assessments were performed in accordance with UTI criteria. 3. Final cure rate was 94.1% (32/34) in group A and 97.2% (35/36) in group B, with no significant difference. 4. The incidence of clinical adverse reactions was 4.3% of 46 patients in group A and 8.0% of 50 patients in group B, and of laboratory adverse reactions, 4.4% of 45 patients and 2.0% of 50 patients in group B, and the difference was not significant. None of the findings in adverse reactions were serious. Also no significant difference between the two groups in the overall safety rating and clinical value was noted. From the results of this study, we conclude that GFLX is safe and effective for the treatment of acute uncomplicated cystitis, and 100 mg b.i.d. for 3 days is sufficient as the dosage of GFLX.
|Number of pages||14|
|Journal||Japanese Journal of Chemotherapy|
|Publication status||Published - Dec 1 1999|
ASJC Scopus subject areas
- Pharmacology (medical)