Vol.55 No.S-1 October 2007
Clinical phase III open-label study of oral Garenoxacin in patients with otorhinolaryngological infection
1)Nagoya City University, Medical School, 1 Azakawasumi, Mizuhocho, Mizuho-ku, Nagoya, Aichi, Japan
2)Department of Otolaryngology, The Second Hospital, Fujita Health University, School of Medicine
3)Department of Otolaryngology-Head and Neck Surgery, Wakayama Medical University
4)Hiroshima University, School of Medicine
Abstract
Pharmacokinetic and clinical studies on garenoxacin mesilate hydrate(GRNX), a new synthetic des-F(6)-quinolone antimicrobial agent, 400 mg once daily were observed in otorhinolaryngological infections.
1. Penetration into tissues: The concentration of GRNX were 6.01 μg/g in maxillary sinus mucosa, 5.89 μg/g in middle ear mucosa, and 9.44 μg/g in tonsil at 2.5-3.5 hours after GRNX 400 mg p.o.. The ratio against plasma concentration was 1.03-1.61.
2. Clinical efficacy: Clinical efficacy rates were 92.0% (23/25) in paranasal sinusitis, 95.2% (20/21) in acute tonsillitis, 85.0% (17/20) in acute pharyngolaryngitis and 87.2% (41/47) in acute and otitis media. Overall clinical efficacy rate was 89.4% (101/113).
3. Bacteriological response: Bacteriological eradication rates were 94.1% (32/34) in S. aureus, 100% (20/20) in S. pneumoniae, 100% (20/20) in H. influenzae, 100% (14/14) in M. (B. ) catarrhalis, 2/3 in MRSA, 5/5 in PRSP, 3/3 in PISP, 100% (14/14) in BLNAR. Overall bacteriological eradication rate was 97.8% (131/134).
4. Safety: Side effects were observed in 17.4% (21/121), but no serious or clinically significant event was noted.
Results, indicate that GRNX is a very useful medication for the treatment of otorhinolaryngological infections.
Key word
garenoxacin, T-3811MEa, des-fluoro(6)-quinolone, otorhinolaryngological infection, tissue penetration
Received
June 27, 2007
Accepted
August 9, 2007
Jpn. J. Chemother. 55 (S-1): 194-205, 2007
