急性歯性感染症に対するBMY-28100の臨床評価

Cefaclorを対照とする二重盲検比較試験

抄録

The clinical usefulness of BMY-28100, a new oral cephem antibiotic, was compared objectively with that of cefaclor (CCL) using a double-blind method in the department of orofacial odontogenic infections.
A total of 190 patients were administered with the test substances (BMY-28100 and CCL), and the clinical efficacy of 84 patients in the BMY-28100 group and of 83 patients in the CCL group was evaluated. Efficacy rate as evaluated by the score method was 83.3% in the BMY-28100 group and 85.5% in the CCL group.
Efficacy rate as evaluated by the investigators was 82.1% in the BMY-28100 group and 84.3% in the CCL group. The differences between the 2 drug groups were not statistically significant. The organisms were isolated in 64 patients (30 in the BMY-28100 group and 34 in the CCL group), and the difference between the 2 drug groups in these patients was also not statistically significant.
Adverse reactions were observed in 1 patient in the BMY-28100 group and in 4 patients in the CCL group, while abnormal laboratory findings were observed in 2 patients (3 cases) in the BMY-28100 group and in 3 patients (3 cases) in the CCL group. None of these differences was statistically significant.
The usefulness rates were almost the same for the 2 drug groups.
The results indicated that BMY-28100 was almost equal to CCL in utility evaluations in the treatment of orofacial odontogenic infections.