Vol.56 No.S-1 April 2008
Efficacy and safety of sitafloxacin in patients with otorhinolaryngological infections and its tissue distribution in the otorhinolaryngological field
1)Nagoya City University Medical School, 1 aza-Kawasumi, Mizuho, Mizuho-ku, Nagoya, Aichi, Japan
2)Department of Otolaryngology, Second Hospital, Fujita Health University School of Medicine
3)Department of Otorhinolaryngology, Wakayama Medical University
4)Department of Otolaryngology, Yamaguchi University Graduate School of Medicine
5)Department of Otolaryngology, Head and Neck Surgery, Kagoshima University Graduate School of Medical and Dental Sciences
6)Department of Pharmacology, Jikei University School of Medicine
Abstract
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 paranasal sinusitis, and at 50 mg twice for 7 days in tonsillitis, pharyngitis, and laryngitis.
Key word
sitafloxacin, otorhinolaryngological infections, clinical trial, pharmacokinetics
Received
November 2, 2007
Accepted
January 22, 2008
Jpn. J. Chemother. 56 (S-1): 110-120, 2008
