1997 Volume 45 Issue 7 Pages 506-524
Grepafloxacin (GPFX), a new fluoroquinolone, and ofloxacin (OFLX) were compared in a multicenter, double-blind, double-placebo study in the treatment of skin and skin structure infections. Patients with deep-seated hair follicle infections (furuncles, furunculosis, and carbuncles) and deep-seated diffuse infections (cellulitis and erysipelas) were enrolled after their informed consent was obtained. Patients assigned to the GPFX group received one 200-mg tablet of GPFX once a day after breakfast and two placebo OFLX tablets after meals (t. i. d.). Patients assigned to the OFLX group received one placebo tablet of GPFX once a day after breakfast and two 100 mg OFLX tablets after meals (t. i. d.). The patients were treated for 7 days. Patients were evaluated in terms of efficacy, safety, and bacteriologic response. Efficacy was evaluated on day 4 (3-5) and on day 7 (6-8). Two hundred twenty-seven patients (GPFX group, 114 patients; OFLX group, 113 patients) were enrolled. The clinical efficacy rates were 90.5%(95/105) in the GPFX group and 88.5%(92/104) in the OFLX group. The overall improvement rates on day 4 were 73.9 %(65/88) in the GPFX group and 77.9%(67/86) in the OFLX group. The safety rates were91.7%(100/109) in the GPFX group and 85.5%(94/110) in the OFLX group. The usefulness rates were 87.7%(93/106) in the GPFX group and 83.5%(91/109) in the OFLX group. Adverse reactions were seen in 6.4% of patients treated with GPFX and in 9.1% of patients treated with OFLX. The main adverse reactions were of gastrointestinal origin. None of them were severe. Abnormal laboratory findings were all minor (2.2% in the GPFX group and 7.6% in the OFLX group). The bacteriologic response rates were 89.0% for the GPFX group and 90.9% in the OFLX group. These differences were not statistically significant. These results suggest that GPFX at a dose of 200 mg once a day is as effective and safe as OFLX at a dose of 200 mg three times a day in the treatment of skin and skin structure infections.
