急性陰窩性扁桃炎に対するCefuroxime axetilの薬効評価

二重盲検法によるCefaclorとの比較試験

抄録

A double blind comparative study was performed on cefuroxime axetil (CXM-AX), to evaluate objectively its efficacy, safety and usefulness in acute tonsillitis, using cefaclor (CCL) as the comparator. Either of the drugs was administered in the dose of 250 mg tid., in principle for 7 days.
1. In the evaluation of clinical efficacy, the efficacy rates of CXM-AX and CCL were 90.5% (95/105) and 88.2% (90/102), respectively, in the assessment by doctors in charge, and 88.6% (93/105) and 87.3% (89/102), respectively, in the assessment by the committee, without statistically significant difference between the two treatment groups.
2. When the bacteriological response was evaluated in each case, the elimination rate was 98.0% (96/ 98) in CXM-AX group and 98.9% (91/92) in CCL group, and there was no significant difference between the two groups either in this comparison or in the evaluation on the bacteriological response classified by causative organisms.
3. In overall safety, no significant difference was observed between two treatment groups. Adverse events, all of which were gastrointestinal tract symptoms, were observed in 2.6% (3/114) in CXM-AX group, and in 2.7% (3/111) in CCL group. Either in adverse events or abnormal laboratory findings, the difference in incidences was not statistically significant between the two groups.
4. The usefulness rates of CXM-AX and CCL were 93.3% (98/105) and 91.2% (93/102), respectively, with no significant difference. The above results suggest that CXM-AX is a very useful drug for the treatment of acute tonsillitis.