咽頭炎と口内炎に対するアズノ-ルS錠薬物の二重盲検比較対照試験

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The efficacy and safety of Azunol-S (AZ-S) were compared with those of an inert placebo (AZ-S-P) in the treatment of pharyngitis and stomatitis (including glossitis) in a multicentered double blind clinical trial. A tablet of AZ-S or AZ-S-P was inserted into the labiogingival region of the upper jaw. The procedure was performed 4 times a day for 7 days. Patients' impressions and change of the inserted region were checked.1. A total number of 160 patients was enrolled at 8 collaborating hospital clinics. One hundred and fifty-nine patients (including 8 drop-outs) of the 160 patients were available for statistical analysis of the effect (Chi-square and Wilcoxon's ranked sum tests): 42 patients received AZ-S, 40 of the 82 pharyngitis patients received AZ-S-P and the remaining patients received AZ-S, 38 of the 77 patients of stomatitis received AZ-S-P.2. As for the final global judgment in pharyngitis and stomatitis, AZ-S was more effective than AZ-S-P at P<0.05 in both Chi-square and Wilcoxon's ranked sum tests.3. AZ-S brought more relief of spontaneous pain, strange feeling, swallow pain, redness and swelling than AZ-S-P in pharyngitis. (P<0.05 or P<0.01 Wilcoxon ranked sum test)4. AZ-S brought more relief of stimulus pain, redness, strange feeling, touch pain and spontaneous pain than AZ-S-P in stomatitis. (P<0.05 or P<0.01 Wilcoxon ranked sum test)5. No general or local side effects were found with AZ-S or AZ-S-P.6. When an AZ-S or AZ-S-P tablet was inserted into the labiogingival region of the upper jaw, it remained stable. Patients did not complain of unpleasant feeling and had no speech difficulties.Consequently the AZ-S tablet was recognized as a useful new drug.

咽頭炎と口内炎に対するアズノ-ルS錠薬物の二重盲検比較対照試験

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