Ofloxacin in respiratory tract infection. A review of the results of clinical trials in Japan.

An open clinical study of ofloxacin in respiratory tract infections was conducted with patients receiving daily doses of ofloxacin 300 mg, 400 mg or 600 mg. The duration of treatment was 6 to 14 days for 70% of the patients. Ofloxacin was effective in 668 of 828 patients analysed (80.7%). Of 293 patients with upper respiratory infections, the efficacy rate was 85.3%. In 535 cases with lower respiratory infections, ofloxacin was effective in 78.1%. It is noteworthy that a 70% efficacy rate was obtained in 80 cases with intractable chronic diffuse panbronchiolitis primarily associated with Pseudomonas aeruginosa. There was no difference in the efficacy rate among various daily doses or severity of infections. In lower respiratory infections the bacterial eradication rate was 80.9% for Gram-positive aerobes (including 80% for Staphylococcus aureus and 76.5% for Streptococcus pneumoniae) and 72.1% for Gram-negative aerobes (including 92.6% for Klebsiella pneumoniae, 32.3% for P. aeruginosa and 97.1% for Haemophilus influenzae). Although there were no serious cases, adverse reactions were noted in 46 of 843 patients (5.5%): 38 cases (4.5%) of gastrointestinal tract reactions (nausea, vomiting, heartburn, etc.), 4 cases (0.5%) of hypersensitivity (e.g. eruption) and 19 (2.3%) of central nervous system effects (e.g. dizziness). Abnormal changes in laboratory findings included elevations of AST (1.2%) and ALT (1.5%) and an increase in the eosinophil count (1.7%).