Abstract
We compared the clinical efficacy, safety and utility of T-3262 (tosufloxacin tosilate), a new derivative pyridonecarboxylic acid, with those of ofloxacin (OFLX) in patients with respiratory tract infection (RTI) by double-blind study. RTI included in the protocol were bacterial pneumonia and chronic respiratory tract infection. The drug was given orally for a fixed period of 14 days and the daily dosage was fixed at 450mg for T-3262 or 600mg for OFLX. The following results were obtained. 1. On the basis of committee judgement, the clinical efficacy rate in all cases was 82.9% for T-3262 and 82.5% for OFLX. No significant difference was observed between the two groups, not even in clinical efficacy when classified by type of disease. 2. The clinical efficacy rate judged by the doctors in charge was similar to that judged by the committee. 3. The bacteriological eradication rate of causative organisms judged by the committee was 78.6% for T-3262 and 85.1% for OFLX, without statistically significant difference. 4. With respect to the rate of improvement of clinical signs, symptoms and laboratory findings, T-3262 was superior to OFLX as to body temperature. 5. The incidence rate of side effects was 7.8% for T-3262 and 6.7% for OFLX, and there were no significant differences between the two groups. Abnormalities in laboratory findings, mainly slightly elevated serum transaminase and eosinophils, were not significantly different between the two groups. 6. The utility rate in all cases judged by the committee was 79.6% for T-3262 and 79.8% for OFLX. No significant difference between the two groups was noted. Even when classified by type of disease, there was no significant difference in utility between the two groups. 7. Neither was there any significant difference between the two groups in the utility rate when judged by the doctors in charge. 8. From our results, we consider both T-3262 (at a daily dose of 450 mg) and OFLX (at a daily dose of 600mg) to be highly useful antibacterial agents for the treatment of respiratory tract infections.
Original language | English |
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Pages (from-to) | 1086-1118 |
Number of pages | 33 |
Journal | Chemotherapy |
Volume | 37 |
Issue number | 8 |
DOIs | |
Publication status | Published - 1989 |
Externally published | Yes |
ASJC Scopus subject areas
- Pharmacology (medical)
- Infectious Diseases
- Pharmacology
- Drug Discovery
- Oncology