Fundamental and clinical studies on efficacy of Pazufloxacin for sinusitis

Abstract

In order to evaluate the efficacy and safety of Pazufloxacin (PZFX), a new oral quinolone antibacterial agent, for sinusitis, a general clinical trial using a multicenter integrated protocol was performed in addition to a pharmacokinetic study, including the nasal mucosa. The results were as follows:
1. PZFX showed a good penetration into the maxillary sinus mucosa, maxillary sinus retention fluid, nasal polyps and ethmoid sinus mucosa.
2. The efficacy rate in 45 evaluable cases was 83% for acute sinusitis treated with 100 or 200mg of PZFX 2-3 times a day and 80% for acute exacerbation of chronic sinusitis. The overall efficacy rate was 82%.
3. The improvement rate of the X-ray findings in 37 cases was 65%.
4. The bacteriological eradication rates were 82% for gram-positive and 100% for gram-negative bacteria in the case of a monomicrobial infection. The overall eradication rate was 78% when polymicrobial infection cases were included as well.
5. No adverse reaction occurred in any examined case. As for the abnormal laboratory findings, eosinophilia and increased monocytes in 1 patient each were observed and only mild in severity. Based on these results, PZFX was thus suggested to be a very useful drug for the treatment of sinusitis at 300-600mg a day.