To evaluate the clinical efficacy, clinical cure effect and safety of gatifloxacin (GFLX), 8-methoxyquinolone derivatives, in prostatitis and the penetration of GFLX into prostatic fluid in healthy volunteers, we performed a clinical study. Six healthy volunteers received 200 mg of GFLX as a single oral dose and the drug's penetration into prostatic fluid at 2 and 4 hours was evaluated. Thirty-two patients orally received 200 mg b.i.d. of GFLX for 14 days and were evaluated on Day 7, 14 and 28, and the clinical efficacy was assessed in accordance with the criteria of the Japanese UTI Committee. 1. The concentrations of GFLX in prostatic fluid ranged from 0.65 to 2.20 and from 1.02 to 1.56 μg/mL, and concentration ratios to serum were 0.98 and 1.03 at 2 and 4 hours, respectively. 2. In acute bacterial prostatitis, including chronic bacterial prostatitis acutely aggravated, the overall clinical efficacy rate (excellent and moderate responses) was 100% (7/7) on Day 7. Also clinical cure rates on Day 14 (time of final dosing) and 28 (2 weeks after dosing) were 100% (6/6). 3. In chronic bacterial prostatitis, the overall clinical efficacy rate was 100% (9/9) on Day 14. On Day 28 (2 weeks after dosing), 7 of 7 patients were clinically cured. 4. The incidence of clinical adverse reactions was 6.3% of 32 patients, and of laboratory adverse reactions was 9.7% of 31 patients. None of the findings in adverse reactions were serious. From the results of this study, we conclude that GFLX penetrates the prostatic fluid well, and is safe and effective in the treatment of prostatitis.
|Number of pages||9|
|Journal||Japanese Journal of Chemotherapy|
|Publication status||Published - Dec 1 1999|
ASJC Scopus subject areas
- Pharmacology (medical)