口腔乾燥症に対するFEM-102の臨床試験成績

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In order to invcstigate the clinical effect of FEM-102 (each tablet contains 12.5 mg of Anethole Trithione) on dryness of mouth due to Xerostomia, Sjögren's syndrome and radiotherapy, two tablets of FEM-102 were administered orally t.i.d.(75 mg of Anethole Trithione/day) during 2-12 weeks.<BR>The results were as follows:<BR>1. The efficacy on dryness of mouth was evaluated on the basis of objective findings, subjective symptoms and test of saliva and salivation.The rate of effectiveness (above effective) in Xerostomia, Sjögren's syndrome and post-radiotherapy were 72.2% (26 cases/36 cases), 42.9% (3 cases/7 cases) and 33.3% (2 cases/6 cases), respectively.<BR>2. Increase in salivation was recognized in the patients with Xerostomia and Sjögren's syndrome after administration of FEM-102.<BR>3. As for the adverse reactions, no remarkable finding was obtained, except digestive-tract symptoms such as break wind, flatulence and sensation of abdominal distension in 11 cases.
社団法人日本口腔外科学会の論文