耳鼻咽喉科領域におけるpazufloxacinの基礎的・臨床的検討

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  • Basic and clinical studies on pazufloxacin in otorhinolaryngological infections

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A newly developed oral quinolone, pazufloxacin (PZFX), was used in infections in the field of otorhinolaryngology, and its usefulness, safety and pharmacokinetics were studied.<BR>Prior to surgery, 200mg of PZFX was orally administered to 20 patients with chronic sinusitis, chronic otitis media and tonsillitis, and their plasma and tissue levels were determined 2-9 hours later.<BR>The clinical study was performed in 61 patients including 16 with otitis media (5 acute, 11 chronic acute exacerbation), 17 with sinusitis (14 acute, 3 chronic acute exacerbation), 19 with tonsillitis, 4 with pharyngitis and 5 with acute external otitis. The drug was orally administered at a single dose of 100-200mg 2-3 times a day (daily dose, 300-600mg) for 2-15 days.<BR>In pharmacokinetic study, maximum levels (1.43-2.10μg/ml) in plasma were observed 2-3 hours after administration of PZFX, and then declined gradually. The tissue concentration in the middle ear reached 0.16-1.3μg/g 2-9 hours after administration. In the clinical study, 13 of 61 patients were excluded: 9 who did not come to the hospital, 1 in whom the drug was withdrawn because of side effects, 1 in whom a prohibited drug was used concomitantly, and 2 with other diseases. Therefore, the clinical effect was determined in 48 patients. Efficacy rates were 91.7% (11/12) in otitis media, 85.7% (12/14) in sinusitis, 68.8% (11/16) in tonsillitis, 4/4 in pharyngitis and 2/2 in external otitis, a total efficacy rate of 83.3%. Bacteriologically, 30 of 32 strains of gram-positive organisms and 6 of 7 strains of gramnegative organisms were eradicated, an eradication rate of 90.2% (37/41).<BR>Adverse effects, diarrhea was observed in 1 of 59 patients studied, and the laboratory findings showed elevation of GPT in 1 of 37 patients tested.<BR>The results suggest that PZFX is a useful antimicrobial agent for the treatment of otorhinolaryngological infections.

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