A double blind study was performed on cefuroxime axetil (CXM-AX), a new oral cephem, for objective evaluation of its clinical efficacy, safety and usefulness in superficial suppurative skin and soft tissue infections, using cefaclor (CCL) as the comparator. In both CXM-AX and CCL group, the daily dose was 750 mg and the drug was administered consecutively for 10 days in Group I, II, III and IV and for 14 days in Group V and VI.
A total of 248 patients (CXM-AX: 121, CCL: 127) were treated, among whom 228 (CXM-AX: 115, CCL: 113) were analysed for overall clinical efficacy and general usefulness, and 235 (CXM-AX: 117, CCL: 118), for overall safety. The following results were obtained.
1. In the evaluation of overall clinical efficacy, the efficacy rate (‘Cured., ’‘Remarkably improved’ and ‘Improved’) was 84.3%(97/115) in CXM-AX group and 85.0%(96/113) in CCL group, with no significant difference between the two drugs. Also in clinical efficacy evaluated for each diagnosis group, there was no statistically significant difference.
2. Bacteriologically, the eradication rate was 86.7%(65/75) in CXM-AX group and 87.0%(60/69) in CCL group, there being no significant difference.
3. Adverse events were observed in 10 out of 117 cases (8.5%) in CXM-AX group, and in 5 out of 118 cases (4.2%) in CCL group. Abnormal laboratory findings were noted in 5 out of 79 cases (6.3%) in CXM-AX group, and in 4 out of 67 cases (6.0%) in CCL group. There was no significant difference. The overall safety rates (‘Safe’ and ‘Nearly safe’) based on clinical adverse events and abnormal laboratory findings were 94.9%(111/117) and 96.6%(114/118) in CXM-AX group and CCL group, respectively, vvithout significant difference.
4. When general usefulness was assessed based on overall clinical efficacy and safety, the usefulness rates (‘Remarkably useful’ and ‘Useful’) were 76.5%(88/115) and 77.9%(88/113) in CXM-AX group and CCL group, respectively, and there was no significant difference.
The above results have shown that CXM-AX is a useful drug, like CCL, for the treatment of superficial suppurative skin and soft tissue infections.
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