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本試験では,スギ花粉の人工的曝露(花粉曝露施設:OHIO Chamber)により発現させた鼻炎症状に対するフェキソフェナジン塩酸塩/塩酸プソイドエフェドリン配合錠の有効性を検討した。対象は日本人成人のスギ花粉症患者24名とした。2時間の花粉曝露により鼻炎症状を有する被験者に同剤を投与し,その後3時間にわたって曝露を継続した。投与3時間後のTotal Nasal Symptom Score(TNSS)の変化量は-5.3(90%CI:-6.4,-4.1)と有意に改善した(p<0.0001)。本試験の結果,スギ花粉による鼻炎症状増悪時に同剤を投与することによって,鼻炎症状全般に速やかな改善効果が期待できることが示唆された。
This study evaluated Fexofenadine/Pseudoephedrine combination tablet against nasal symptoms induced by Japanese cedar pollen under artificial exposure using the OHIO Chamber unit. In total, 24 adult Japanese patients with cedar pollinosis were included into analysis. The study drug was administered 2 hours after the start of exposure(baseline), and patients had an additional 3 hours of pollen exposure. Significant improvement in the TNSS(Total Nasal Symptom Score)score from baseline to 3 hours after the study drug administration was detected with the mean change of-5.3(90%CI:-6.4,-4.1)(p<0.0001). Results of this study suggest that rapid improvement of exacerbated nasal symptoms which were induced by Japanese cedar pollen was expected with Fexofenadine/Pseudoephedrine administration.