Abstract
To objectively evaluate the appropriate clinical dose of fleroxacin, a new quinolone antibacterial agent, in the treatment of chronic respiratory tract infections, we carried out a dose-finding comparative study using ofloxacin (OFLX) as the control drug. Patients were given fleroxacin at a single daily dose of 200 mg or 300mg or 600mg of OFLX (t. i. d.) for 14 days in principle. The following results were obtained. 1. The clinical efficacy rates (including excellent and good) as judged by the committee were 62.2%(28/45) in the fleroxacin 200 mg group, 90.0%(36/40) in the fleroxacin 300 mg group and 77.3%(34/44) in the OFLX group. There was a significant difference between the 200 mg and 300 mg fleroxacin groups. 2. Bacteriologically, the eradication rates were 65.4%(17/26) in the fleroxacin 200 mg group, 73.9%(17/23) in the fleroxacin 300 mg group and 75.9%(22/29) in the OFLX group. 3. The incidence of side effects was 8.5%(4/47) in the fleroxacin 200 mg group, 9.5%(4/42) in the fleroxacin 300 mg group and 4.3%(2/46) in the OFLX group. They were not serious in degree. 4. The incidence of abnormal changes in laboratory test values was 7.1%(3/42) in the fleroxacin 200 mg group, 8.3%(3/36) in the fleroxacin 300 mg group and 25.6%(11/43) in the OFLX group. All changes were mild in degree. 5. The utility rates (including markedly useful and useful) as judged by the committee were 62.2%(28/45) in the fleroxacin 200 mg group, 85.4%(35/41) in the fleroxacin 300 mg group and 75.6%(34/45) in the OFLX group. There was a significant difference between the 200mg and 300 mg fleroxacin groups. Our results suggest that a daily dose of 300mg of fleroxacin is a suitable clinical dosage in treating chronic respiratory tract infections.
Original language | English |
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Pages (from-to) | 454-471 |
Number of pages | 18 |
Journal | Chemotherapy |
Volume | 38 |
DOIs | |
Publication status | Published - 1990 |
Externally published | Yes |
Keywords
- Chronic respiratory tract infection
- Dose-finding study
- Fleroxacin
ASJC Scopus subject areas
- Pharmacology (medical)
- Infectious Diseases
- Pharmacology
- Drug Discovery
- Oncology