A COMPARATIVE STUDY ON CEFUROXIME AXETIL AND CEFACLOR IN THE TREATMENT OF ACUTE UNCOMPLICATED CYSTITIS
1987 Volume 35 Issue 4 Pages 347-371
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1987 Volume 35 Issue 4 Pages 347-371
To evaluate objectively the efficacy, safety and usefulness of cefuroxime axetil (CXM-AX), a new oral cephalosporin, in the treatment of acute uncomplicated cystitis, a comparative double blind trial was performed using cefaclor (CCL) as the control drug. In both groups, the drug was administered after meals for seven days in the dose of 250 mg tid. and clinical efficacy was assessed on the 3 rd day (the 1 st assessment) and 7 th day (the 2 nd assessment) of dosing. Further, in the patients who showed excellent response at the 2 nd assessment, recurrence was examined on the 14 th day (the 3 rd assessment) and on around the 21 st day (the 4 th assessment) following the subsequent 7-day placebo treatment.
L A total of 330 patients (CXM-AX 166, CCL 164) were treated, among whom clinical efficacy was evaluable in 235 patients (CXM-AX: 119, CCL: 116) at the 1 st assessment, and in 185 patients (CXM-AX: 98, CCL: 87) at the 2 nd assessment.
2. In the evaluation of overall clinical efficacy by the committee, the efficacy rates (‘excellent’ and ‘good’) in CXM-AX group and CCL group were 95.8% and 97.4%, respectively at the 1 st assessment and 98.0%and100%, respectively at the 2 nd assessment. The figures were very high in both groups and there was no statistically significant difference between the two groups. In the 1 st and 2 nd assessments on effects of drugs on pain on micturition, pyuria and bacteriuria and on bacteriological response, no significant difference was observed between the two treatments.
3. In the 1 st and 2 nd assessments on clinical efficacy by doctors in charge, the efficacy rates of 95% or higher were achieved in both groups, with no significant difference between the two drugs. However, the rate of ‘excellent’ cases in CCL group (71. 6%) was significantly higher than that in CXM-AX group (58.0%) in the 1 st assessment (P<0.05).
4. Recurrence was examined in 77 cases (CXM-AX: 40, CCL: 37) at the 3 rd assessment, and in 26 cases (CXM-AX: 14, CCL 12) at the 4 th assessment. In either of the assessments, there was no significant difference in recurrence rates between these groups.
5. Side effects were observed in 6 cases (4.0%) in CXM-AX group, and in 4 cases (2.5%) in CCL group. Abnormal laboratory findings were noted in 2 cases (2.9%) in CXM-AX group. The difference between the two groups was not statistically significant.
6. In the usefulness evaluated by doctors in charge at the 1 st and 2 nd assessments, no significant difference was observed between the two treatments.
