口腔外科領域感染症に対するT-3262 (Tosufloxacin tosilate) とCefaclor (CCL) の薬効比較試験成績

抄録

The clinical effectiveness, safety and usefulness of T-3262 (tosufloxacin tosilate), a new oral Quinolone antibacterial agent for the treatment of oral infections, was compared with that of Cefaclor (CCL) by a double-blind method.
The diseases covered by this study were periodontal infections, pericoronitis and osteitis of jaw. Drugs were administered for 3-7 days at doses of 150 mg t.i.d. (T-3262) and 250 mg t.i.d. (CCL) . A total of 259 cases were enrolled in the study.
Results obtained were as follows:
1) The clinical efficacy was evaluated by the doctors in charge and the numerical rating on the 3rd day of treatment in 246 cases (122 in the T-3262 group and 124 in the CCL group) .
The clinical efficacy rate according to the doctors in charge was 80.3% for the T-3262 group and 81.5% for the CCL group. The evaluation of the numerical rating was 86.9% for the T-3262 group and 85.5% for the CCL group.
There was no significant difference in clinical effectiveness between the two groups according to these two methods of clinical judgement.
2) Some side effects were observed in 3 cases (2.3% of 128) treated with T-3262 and in 5 cases (3.9% of 127) treated with CCL, but no severe symptoms were seen. Abnormal changes in laboratory findings were noted in 4.8% in the T-3262 group and 15.4% in the CCL group.
There was no significant difference in safety between the two groups.
3) In terms of clinical usefulness as well, there was no significant difference between the two groups.
From these results, it is concluded that T-3262 is as effective as CCL in the treatment of oral infections.