The analgesic effects and safety of a 0.15% benzydamine gargle preparation (NIK-237) on aphtha and lichen planus lesions were investigated in a controlled study using placebo. The clinical effects of each drug were evaluated in 149 patients (NIK-237-treated group: 75, placebo-treated group : 74), and the following results were obtained.
1) Analgesic effect according to the judgment of the physician in charge : The NIK-237-treated group was superior, with a significant difference being observed (
p<0.05) compared to the placebo-treated group.
2) Analgesic effect by scoring: The NIK-237-treated group was superior, with a significant difference being observed (
p<0.05) compared to the placebo-treated group.
3) Overall safety rating : Both groups were judged to produce no side effects.
4) Usefulness : The NIK-237-treated group was superior, with a significant difference being observed (
p<0.05) compared to the placebo-treated group.
5) Improvement rating of spontaneous pain with time : The NIK-237-treated group was superior (
p<0.05) or tended to be superior (
p<0.1) to that of the placebo-treated group 15, 60 and 120 minutes after administration of the drugs.
6) Effect on pain at the time of eating : The NIK-237-treated group tended to be superior (
p<0.1) to that of the placebo-treated group.
From the above results, it is concluded that NIK-237 is highly useful for the treatment of oral mucosal diseases.
抄録全体を表示