Abstract
Basic (transfer into gallbladder tissue) and clinical studies of pazufloxacin (PZFX), a newly developed piribone-carboxylic acid antimicrobialagent for oral use, were performed.
The subjects were 6 patients with cholecystolithiasis with normal liver function who were scheduled for cholecystectomy. PZFX was orally administered in the fasting state preoperatively at a dose of 200mg, and 2 hours later, its serum and gallbladder tissue concentrations were measured. Evaluation was possible in 4 patients. The mean serum concentration was 0.20±0.25μg/ml (0.04-0.57μg/ml), and the mean tissue concentration was 0.26±0.22μg/ml (0.11-0.57mg/g). The mean ratio of the tissue concentration to the serum concentration was 2.22±1.27 (1.00-3.75)
The efficacy of PZFX in 14 patients with surgical infection was excellent in 2 patients, good in 9, fair in2 and unevaluable in 1. The efficacy rate was 84.6%(11/13).
Bacteriologically, six strains (2 strains of Staphylococcus aureus, one strain of Escherichia coli, 2 strains of Peptostreptococcus, and one strain of Bacteroides fragilis) were isolated from five patients, and all strains were eradicated after the treatment.
No side effects were observed during medication. The only abnormal finding on clinical tests was an lymphocytosis in one patient.
These findings indicate that PZFX is effective in treating surgical infection. As for transfer of PZFX into gallbladder tissue, further study will be needed.
