Abstract
To evaluate the efficacy, safety and usefulness of levofloxacin (LVFX, DR-3355) in chronic respiratory tract infections, we carried out a double-blind comparative study with ofloxacin (OFLX) as the control drug. LVFX at a dose of 300mg (100mg × 3/day) and OFLX at a dose of 600mg (200mg × 3/day) were orally administered for 14 days. The results were as follows: 1) A total of 165 patients (LVFX 83, OFLX 82) were enrolled in the trial. The number of evaluable cases, based on the criteria of the investigators' committee, was 148 for clinical efficacy (LVFX 72, OFLX 76), 159 for side effects (LVFX 78, OFLX 81), 150 for laboratory findings (LVFX 73, OFLX 77), and 149 for usefulness (LVFX 73, OFLX 76). There were no significant differences in the background factors of the patients, except in the distribution of underlying diseases and/or complications between the two groups. 2) The clinical efficacy rates, judged by the committee, were 87.5% (63/72) for the LVFX group and 78.7% (59/75) for the OFLX group, and judged by the doctors in charge they were 86.1% (62/72) and 82.2% (60/73), respectively. There was no significant difference between the two groups. 3) The bacteriological eradication rates were 86.4% (38/44) in the LVFX group and 79.2% (38/48) in the OFLX group. There was no significant difference between the two groups. 4) The incidences of side effects were 6.4% (5/78) in the LVFX group and 11.1% (9/81) in the OFLX group. There was no significant difference between the two groups. The incidences of abnormal laboratory findings were 6.9% (5/73) in the LVFX group and 18.2% (14/77) in the OFLX group. The incidence of abnormal laboratory findings in the LVFX group was significantly lower than that in the OFLX. 5) The usefulness rates, judged by the committee, were 86.1% (62/72) for the LVFX group and 73.3% (55/75) for the OFLX group, and judged by the doctors in charge they were 84.7% (61/72) and 79.5% (58/73), respectively. There was no significant difference between the two groups. The above results indicate that LVFX (100mg × 3/day) is as useful as OFLX (200mg × 3/day) in the treatment of chronic respiratory tract infections.
Original language | English |
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Pages (from-to) | 97-120 |
Number of pages | 24 |
Journal | Chemotherapy |
Volume | 40 |
DOIs | |
Publication status | Published - 1992 May |
Externally published | Yes |
Keywords
- DR-3355
- Levofloxacin
- Ofloxacin
ASJC Scopus subject areas
- Pharmacology (medical)
- Infectious Diseases
- Pharmacology
- Drug Discovery
- Oncology