Fundamental and clinical studies on the efficacy of Pazufloxacin for otitis media, otitis externa

Abstract

In order to evaluate the efficacy, safety of Pazufloxacin (PZFX) for otitis media and otitis externa, a general clinical trial, using a multicenter integrated protocol was performed in addition to the studies on the sensitivity distribution of isolated bacteria and the pharmacokinetics, including middle ear mucosa. The results were as follows:
1. The sensitivity distribution of 100 strains, isolated from patients with otitis media and otitis externa, was 2-4 times superior to Ofloxacin (OFLX) and almost equal to Ciprofloxacin (CPFX).
2. The concentration of PZFX in the tissue including middle ear mucosa, in two hours after administration at an oral dose, reached 1.20-3.60μg/g (2.39; ration to the serum level-average), which thus indicated good tissue penetration.
3. The efficacy rate in 66 evaluable cases was 79% (52/66) for otitis media and 91% (20/22) for otitis externa.
4. Adverse reactions were observed in 4 of 103 cases (incidence: 3.9%), which were mainly consisted of gastrointestinal disorders.
As for abnormal laboratory changes, elevated GOT and GPT levels were observed in 1 case. These results therefore suggest that PZFX is a very useful drug for the treatment of otitis media and otitis externa.