抄録
In order to evaluate the efficacy, safety and feeling of patients with a spect use of TMD-906 (a double-layer film containing Lithospermum Root extract and glycyrrhetic acid for application to the oral cavity), clinical trials were carried out at Second Department of Oral and Maxillofacial Surgery, School of Dental Medicine, Tsurumi University and First Department of Oral and Maxillofacial Surgery, School of Dental Medicine, Showa University.
The following results were obtained.
1) Of the total 36 cases, 27 cases were acute lesions (11 chronic recurrent aphtha, 11 aphthous atomatitis, 5 the others) and 9 cases were chronic lesions (5 Lichenqlanus, 4 the others) .
2) One to three pieces of TMD-906 were applied to the affected part.
Application periods were less than 5 days in 9 cases, 5 to 10 days in 22 cases and more than 11 days in 5 cases.
3) With respect to improvement of clinical observations, improvement of contact pain was 94.4% (33/35), improvement of pain at meals 97.2% (35/36), alleviation of flare 91.2% (31/34) and alleviation of erosion or ulcer was 89.7% (26/29) .
4) With respect to the feeling of the patients, 100.0% (36/36) of the patients felt “no pain or a little pain” for pain in application. 91.7% (33/36) had “no specific feeling” or “slight feeling of a foreign body” for feeling of adhension.
These results suggested that the feeling of the patient in application was very preferable.
Average duration of adhensive was more than 2 hours in 97.2% (35/36) . Adhesion to lesion for long time was superior pharmaceutical property of this product.
5) Side effects were not reported in any of these cases.
6) General improvement, general safety and efficacy were judged from clinical observat-tions, feeling of patients and side effects.
For general improvement, “remarkable improvement” and “improvement” were 91.7%.
In acute lesion of chronic recurrent pahtha, aphthous stomatitis and the others, each improvement was 100.0%. There was no difference along these diseases.
In chronic lesion, less improvement were observed, the case of Lichen planus was 60.0 %, others were 75.0%.
7) For general safety, all cases were “safety” .
8) For efficacy, “very efficient”and “efficent” were 91.7%.
