Clinical effects of benzydamine hydrochloride gargle preparation (NIK-237) on oral mucosal lesions. A well-controlled comparative study with placebo.:A well-controlled comparative study with placebo
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概要
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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.<BR>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 (<I>p</I><0.05) compared to the placebo-treated group.<BR>2) Analgesic effect by scoring: The NIK-237-treated group was superior, with a significant difference being observed (<I>p</I><0.05) compared to the placebo-treated group.<BR>3) Overall safety rating : Both groups were judged to produce no side effects.<BR>4) Usefulness : The NIK-237-treated group was superior, with a significant difference being observed (<I>p</I><0.05) compared to the placebo-treated group.<BR>5) Improvement rating of spontaneous pain with time : The NIK-237-treated group was superior (<I>p</I><0.05) or tended to be superior (<I>p</I><0.1) to that of the placebo-treated group 15, 60 and 120 minutes after administration of the drugs.<BR>6) Effect on pain at the time of eating : The NIK-237-treated group tended to be superior (<I>p</I><0.1) to that of the placebo-treated group.<BR>From the above results, it is concluded that NIK-237 is highly useful for the treatment of oral mucosal diseases.
- 日本歯科薬物療法学会の論文
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