We conducted a multicenter double blind comparative study using enoxacin (ENX) as a control drug to evaluate the efficacy, safety and usefulness of sparfloxacin (SPFX), a new quinolone, in patients ...with skin and soft tissue infections. The patients were given either SPFX (100mg twice daily) or ENX (200mg three times daily) for 7 to 10 days. A total of 273 cases (SPFX 139, ENX 134) were enrolled in the trial. The number of evaluable cases was 242 for clinical efficacy (SPFX 125, ENX 117), 263 for overall safety (SPFX 136, ENX 127) and 245 for usefulness (SPFX 127, ENX 118). There was no significant difference in the rate of characteristics of the patients between the two groups. 1. The clinical efficacy rate, including excellent and good, was 85.6%(107/125) with SPFX and 79.5%(93/117) with ENX, without any significant difference between the two groups. 2. The bacteriological eradication rate was 80.5%(62/77) with SPFX and 81.4%(48/59) witENX, without any significant differnce between the two groups. 3. The overall safety rate, including safe and nearly safe, was 96.3%(131/136) with SPFX and 94.5%(120/127) with ENX, without any significant difference between the two groups. The incidence of side effects was 2.9%(4/136) with SPFX and 7.9%(10/127) with ENX, and that of abnormal laboratory findings was 7.3%(8/109) with SPFX and 4.0%(4/100) with ENX, without any significant difference between the two groups. 4. The usefulness rate was 82.7%(105/127) with SPFX and 74.6% (88/118) with ENX, with a statistically significant difference between the two groups (p<0.05). From the above results, SPFX was considered to be superior to ENX in the treatment of skin and soft tissue infections.
We performed a multicenter double-blind clinical trial to compare cefditoren pivoxil (CDTR-PI), a new oral cephem antibiotic, with cefaclor (CCL) in the treatment of skin and skin structure ...infections (furuncle, furunculosis, carbuncle, cellulitis, erysipelas, lymphangitis and lymphadenitis). CDTR-PI was given orally in a dose of 200 mg three times a day, and CCL in a dose of 250 mg three times a day. One hundred fifty-nine patients were randomly assigned to receive either CDTR-PI (83 patients) or CCL (76 patients). One hundred fourty-five of these patients (CDTRPI, 73; CCL, 72) were evaluated in terms of efficacy, 150 (CDTR-PI, 77; CCL, 73) in terms of overall safety, and 147 (CDTR-PI, 75; CCL, 72) in terms of clinical usefulness. 1. No significant differences were detected in the efficacy rates between the two drug groups. The overall efficacy rate was 97.3% (71/73) for the CDTR-PI group and 90.3% (65/72) for the CCL group. 2. The global improvement rate after 5 days of treatment was 92.4% (61/66) for the CDTR-PI group and 84.8% (56/66) for the CCL group, with no significant difference between the two drug groups. 3. The safety rate was 87.0% (67/77) for the CDTR-PI group and 93.2% (68/73) for the CCL group, with no significant difference between the two drug groups. 4. The clinical usefulness rate was 90.7% (68/75) for the CDTR-PI group and 88.9% (64/72) for the CCL group, with no significant difference between the two drug groups. 5. The bacteriological response rate was 90.0% (36/40) for the CDTR-PI group and 91.2% (31/34) for the CCL group, with no significant difference between the two drug groups. 6. The side effect incidence was 11.7% (9/77) for the CDTR-PI group and 2.7% (2/73) for the CCL group, with no significant difference between the two drug groups. Abnormal laboratory values were noted in 2 patients in the CDTR-PI group and in 4 patients in the CCL group, with no significant difference between the two drug groups. We conclude that CDTR-PI is as effective, safe and useful as CCL in the treatment of skin and skin structure infections.
