Efficacy and safety of sitafloxacin in patients with otorhinolaryngological infections and its tissue distribution in the otorhinolaryngological field

• Published in: Japanese Journal of Chemotherapy Vol. 56; no. Supplement1; pp. 110 - 120
• Main Authors: Yamanaka, Noboru, Kurono, Yuichi, Hori, Seiji, Yamashita, Hiroshi, Suzuki, Kenji, Baba, Shunkichi
• Format: Journal Article
• Language: Japanese
• Published: Japanese Society of Chemotherapy 2008; 公益社団法人 日本化学療法学会
• Subjects: clinical trial; otorhinolaryngological infections; pharmacokinetics; sitafloxacin
• ISSN: 1340-7007; 1884-5886
• DOI: 10.11250/chemotherapy1995.56.Supplement1_110

The efficacy and safety of sitafloxacin (STFX), a fluoroquinolone antibacterial agent, were investigated in patients with otorhinolaryngological infections. The transferability into tissues of STFX in otorhinolaryngological field was also investigated. 1. Clinical study: STFX at 100 mg was administered twice daily for 7 days to patients with acute otitis media, acute exacerbation of the chronic otitis media, acute rhinosinusitis, and acute exacerbation of chronic rhinosinusitis. STFX at 50 mg was administered twice daily for 7 days to patients with tonsillitis, pharyngitis, and laryngitis. Overall clinical efficacy was 87.8%(43/49) in those with otitis media, 89.4%(42/47) with paranasal sinusitis, and 95.0%(19/20) with tonsillitis, pharyngitis, and laryngitis. Bacteriological elimination was 83.3%(30/36) in those with otitis media, 93.1%(27/29) with paranasal sinusitis, and 100%(12/12) with tonsillitis, pharyngitis, and laryngitis. Adverse reactions occurred in 38.5%(47/122), but all were mild to moderate. 2. Pharmacokinetic study: The ratio against simultaneous serum concentration 2.0 to 4.0 hours after a single administration of STFX at 100 mg in the middle ear mucosa was 1.4±0.7 (mean±SD), the maxillary sinus mucosa was 1.1±0.8, and the ethmoidal sinus mucosa was 1.6±0.5. STFX at 50 mg administered to the palatine tonsil was 1.8±0.4. Adverse reactions numbered 10.0%(3/30), but all were mild. Results suggested that STFX is well transferred tissues in the otorhinolaryngological field and is useful for the treatment of STFX at 100 mg twice for 7 days in otitis media and paranasalsinusitis, and at 50 mg twice for 7 days in tonsillitis, pharyngitis, and laryngitis.