口腔外科領域における小手術後炎症に対する EB-382 (alminoprofen) の臨床効果

―二重盲検比較試験による検討―

抄録

A multi-center double-blind comparative study was conducted in order to evaluate the effectiveness, safety and usefulness of EB-382 (600 mg/day) as preventive treatment for postexodontic inflammation of mandibular impacted wisdom tooth, with flurbiprofen (120 mg/day) as the reference drug.
The results obtained were as follows:
1) The total number of patients were 324, 6 cases were excluded and the remaining 318 cases were evaluated, 162 cases were treated with EB-382 (EB) and 156 cases were treated with flurbiprofen (FP) .
2) Considering background parameters, there was no statistical significant difference between the two groups.
3) According to the doctor's judgement of the clinical efficacy, the rate of“excellent or good” was 75.5% with EB group and 75.2% with FP group. There was no significant difference between two groups.
4) Side effects were observed in 5 cases (3.1%) in EB group and 10 cases (6.4%) in FP group.
5) In the general utility rating, the rate of“extremely useful or useful”was 75.8% with EB group and 74.4% with FP group.
There was no significant difference between two groups.
The results indicate that administration of 600 mg/day EB-382 (in 3 divided dose) is safe and useful in the treatment of postexodontic inflammation.