Clinical study of effects of YN-102 on aphthous stomatitis.
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概要
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In order to clinically review the efficacy, safety and feeling of patients with aspect to the use of YN-102 (a newly-developed thin double-layer film containing corticosteroid for application to the oral cavity), clinical trials were carried out at First and Second Departments of Oral and Maxillofacial Surgery, School of Dental Medicine, Tsurumi University, First and Second Departments of Oral and Maxillofacial Surgery, School of Dentistry, Showa University and Department of Oral Surgery, Kanagawa Dental College for six months between October 1987 and March 1988 in clinical cases of chronic recurrent aphtha or aphthous stomatitis. The following results were obtained.<BR>1) Of the total 47 cases, there were 19 males and 28 females. The 20 to 29 year group (15 cases) and the 40 to 49 year group (10 cases) were the largest in number.<BR>2) Average number of days from onset of disease to consultation was 3. 61, average administration-days 4.77 and average number of disease-days 9.27.<BR>3) With respect to improvement of clinical observations, improvement of contact pain was 91.3% (42/46), improvement of pain at meals 91.3% (42/46), alleviation of flare 77.8 % (35/45), and reduced size of the lesion was 76.1% (35/46) .<BR>4) Overall clinical effect was favorable with an effective rate of 87.2% (41/47) . Clinical effects by disease were 87.1% (27/31) for chronic recurrent aphtha and 87.5% (14/16) for aphthous stomatitis.<BR>5) Rate of usefulness, including "very useful" and "useful" cases was as high as 89.4% (42/47) .<BR>6) Side effects were not reported in any of these cases.<BR>7) With respect to the feeling of the patients, 93.6% of the patients felt "convenient and ordinary" for"convenient to use, "95.7% felt"no pain or a little pain"for"pain in application, "100% had"no specific feeling or a slight feeling of a foreign body"for"feeling of adhesion"and 95.7% responded that YN-102"adhered to the lesion for more than 30 minutes"for "duration of adhesion."These results suggest superior pharmaceutical properties of this product.<BR>8) It is collectively considered from the above results that YN-102 is a useful drug for the treatment of aphthous stomatitis due to its accurate effect, high safety and the favorable responses made by the patients.
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