Abstract
Sparfloxacin (SPFX), a new oral quinolone antibacterial, was evaluated for efficacy, safety and usefulness in patients with bacterial pneumonia by the randomized double blind comparative study using ofloxacin (OFLX) as a control drug. The patients were given either SPFX (300 mg once daily) or OFLX (200 mg three times daily) for 14 days, in principle. The results obtained were as follows: 1) A total of 173 patients (SPFX 86, OFLX 87) were enrolled in the trial. The number of evaluable cases according to the criteria proposed by the committee was 149 for clinical efficacy (SPFX 72, OFLX 77), 164 for side effects (SPFX 82, OFLX 82), 160 for laboratory findings (SPFX 78, OFLX 82), and 150 for usefulness (SPFX 72, OFLX 78). There was no significant difference in the rate of background factors of the patients except in the distribution of severity of the disease between the two groups. 2) The clinical efficacy rate judged by the committee was 93.1% (67/72) in the SPFX group and 90.9% (70/77) in the OFLX group, and judged by the doctor in charge was 93, 1% (67/72) and 92.2% (71/77), respectively, without any significant difference between the two groups. 3) The bacteriological eradication rate was 100% (22/22) in the SPFX group and 96. 6% (28/29) in the OFLX group, without any significant difference between the two groups. 4) The incidence of side effects was 6.1% (5/82) in both groups, and that of abnormal laboratory findings was 19.2% (15/78) in the SPFX group and 19.5% (16/82) in the OFLX group, the difference between the two groups being without any significance. 5) The usefulness rate judged by the committee was 90.3% (65/72) in the SPFX group and 88.5% (69/78) in the OFLX group, and judged by the doctor in charge was 88.9% (64/72) and 87.2% (68/78), respectively, without any significant difference between the two groups. The above results indicate that SPFX (300 mg once daily) is as useful as OFLX (200 mg three times daily) in the treatment of patients with bacterial pneumonia.
Original language | English |
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Pages (from-to) | 429-453 |
Number of pages | 25 |
Journal | Chemotherapy |
Volume | 39 |
DOIs | |
Publication status | Published - 1991 |
Externally published | Yes |
ASJC Scopus subject areas
- Pharmacology (medical)
- Infectious Diseases
- Pharmacology
- Drug Discovery
- Oncology