The clinical efficacy, safety, and usefulness of a new quinolone synthetic antibacterial agent, grepafloxacin (GPFX), in the treatment of pneumonia were evaluated in a double-blind study using ofloxacin (OFLX) as the control drug. GPFX and OFLX were administered by the oral route at a daily dose of 300 mg q.d. and 200 mg t.i.d., respectively, for 14 successive days, in principle. 1. The clinical efficacy rate of GPFX and OFLX in the 225 efficacy-evaluable patients among the 256 patients enrolled in the study was 96.4% (108/112) and 92.9% (105/113), respectively. The difference between the two groups was not statistically significant, and the 90% confidence interval of -1.4% to 8.4% demonstrated the clinical equivalency of the two drugs. 2. The bacterial eradication rate was 96.4% (27/28) in the GPFX group and 97.0% (32/33) in the OFLX group. The rates were not significantly different. 3. Adverse reactions were observed in 2.4% (3/125) of the patients in the GPFX group and 5.0% (6/120) of the patients in the OFLX group. Abnormal clinical laboratory values were observed in 15.8% (19/120) of the patients in the GPFX group and 11.4% (13/114) of the patients in the OFLX group. The differences between the two groups were not statistically significant. The safety rates were 81.8% (98/121) in the GPFX group and 83.5% (96/115) in the OFLX group. The rates were not significantly different. 4. The usefulness rates were 94.5% (104/110) in the GPFX group and 91.0% (101/111) in the OFLX group. The difference between the two groups was not statistically significant, and the 90% confidence interval of -2.2% to 9.3% demonstrated clinical equivalency of the two drugs. The above findings demonstrate that GPFX at 300 mg q.d. is equivalent to OFLX at 200 mg t.i.d. in clinical usefulness in the treatment of pneumonia.
|Number of pages||21|
|Journal||Japanese Journal of Chemotherapy|
|Publication status||Published - 1997|
ASJC Scopus subject areas
- Pharmacology (medical)