歯科・口腔外科領域感染症に対するEnoxacin (ENX) の用量設定比較試験

抄録

A double-blind, group-comparison trial was conducted in 11 institutions to compare Enoxacin (ENX) in daily doses of 300 mg (t.i.d) and 600 mg (t.i.d) in terms of efficacy, safety and utility for the treatment of oral infections such as Periodontal infection, pericoronal infection and osteitis of the jaws. A total of 296 cases are enrolled in this study, 277 cases were evaluated on the efficacy by the criteria of Japanese Society of Oral and Maxillofacial Surgeons (139 for the 300 mg group and 138 for the 600 mg group) and 278 cases were evaluated on the efficacy by the attending doctors (140 for the 300 mg group and 138 for the 600 mg group) .
Results obtained were as follows :
1) According to the criteria on clinical effects, the efficacy rate was 74.8% for the 300 mg group and 79.0% for the 600 mg group. As for the evaluation by the attending doctors, it was 68.6% for the 300 mg group and 74.6% for the 600 mg group. The rating in the 600 mg group was 4 to 6% higher than that in the 300 mg group, but there was no significant difference in the efficacy evaluation between the two groups.
2) Adverse reactions were observed in 8 cases (5.6% of 143) of the 300 mg group and in 11 cases (7.6% of 144) of the 600 mg group, but no serious adverse reactions developed.
3) On clinical usefulness judged by the attending doctors, the ratio of usefulness were 68.1% for the 300 mg group and 73.9% for the 600 mg group. The rating in the 600 mg group was 6% higher than that in the 300 mg group, but there was no significant difference in clinical usefulness between the two groups.
As mentioned above, ENX is considered to be useful medication in the treatment of patients with oral infections.