耳鼻咽喉科領域感染症におけるpazufloxacinの基礎的・臨床的検討

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  • Basic and clinical studies of pazufloxacin in otorhinolaryngological infections

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Basic and clinical studies were performed to investigate the usefulness of a new quinolone antimicrobial drug for oral use, pazufloxacin (PZFX).<BR>1) Salivary gland and tonsil tissue were obtained from 7 subjects and 5 subjects (10 tissue) between 57 and 210 minutes after a single dose of the drug (100 or 200 mg) was orally administered, and the tissue penetration was investigated. The salivary gland concentration of PZFX determined in 7 tissue specimens and 7 serum specimens was 0.40-2.04μg/g. The penetration rate (the ratio of the salivary gland tissue level to the serum level) was 21.1-122.0%. The concentration in tonsil, which was determined in 4 tissue specimens (2 subjects) and 4 serum specimens (2 subjects) that showed an appropriate serum level of PZFX, was 1.32-1.68μ/g. The penetration rate was 68.0-78.9%.<BR>2) In the clinical study, the drug was administered to 24 patients with otorhinolaryngological infections, and its clinical usefulness was evaluated in 23 of them (1 drop-out). The clinical efficacy was as follows: good in 1 and poor in 1 patient with acute otitis media; good in 2 and fair in 1 with acute exacerbation of chronic otitis media; excellent in 1, good in 1, and poor in 2 with acute tonsillitis (including peritonsillitis); excellent in 2, good in 6, and fair in 2 with acute sinusitis; poor in 2 with acute exacerbation of chronic sinusitis; good in 1 with laryngopharyngitis; good in 1 with otitis externa. The overall efficacy rate was 65.2% (15/23).<BR>3) The bacteriological response was evaluated in 15 patients, and the results showed eradication in 8 and microbial substitution in 3. The eradication rate was 73.3%.<BR>4) Abnormal findings on clinical laboratory tests included elevated GOT and GPT levels, elevated urinary sugar level, increased monocytes, and increased eosinophilic leukocytes in 1 patient each, a total of 4 patients. No side effects- were observed.<BR>From these results, PZFX was suggested to be a useful drug in otorhinolaryngological infections.

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