塩酸エピナスチンドライシロップの小児アレルギー性鼻炎における臨床試験

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  • Double-blind Comparative Study of Epinastine Dry Syrup with Ketotifen Dry Syrup in Children with Perennial Allergic Rhinitis
  • 塩酸エピナスチンドライシロップの小児アレルギー性鼻炎における臨床試験--第3相二重盲検比較試験
  • エンサン エピナスチンドライシロップ ノ ショウニ アレルギーセイ ビエン ニ オケル リンショウ シケン ダイ3ソウ ニジュウ モウケンヒカク シケン
  • 第III相二重盲検比較試験

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Purpose: To investigate the efficacy and safety of Epinastine Dry Syrup (5 mg,10 mg, once daily) in children with perennial allergic rhinitis in comparison with Ketotifen Dry Syrup (1.2 mg,2.0 mg twic e daily).<BR>Methods: This was a multicenter, randomized, parallel, double-blind study in children with perennial allergic rhinitis, who were randomly allocated to receive either Epinastine (body weight<24 kg: 5 mg>24 kg: 10 mg, once daily) or Ketotifen (body weight<24 kg: 1.2 mg>24 kg: 2.0 mg, twice daily) for 2 weeks.<BR>Severity scores of each nasal symptom (sneezing, nasal discharge, nasal obstruction) were assessed by investigators at baseline and after 2 weeks of treatment.<BR>The efficacy was analyzed based on the total severity score and the safety was assessed by the frequency of adverse events reported during the study period.<BR>Results: Of the 151 children randomized,142 (Ep inastine: 74 and Ketotifen 68) were included in the efficacy analysis. After 2 weeks of treatment, the changes of the total severity score were 1.42 with E pinastine and 1.55 with Ketotifen (based on the means of least squares).<BR>Since the 95% confidence interval of the difference in leas t squares means between groups was 0.31∼0.57, the comparatively equal efficacy of Epinastine and Ketotifen was proved. Epinastine and Ketotifen were both well-tolerated. Somnolence was repor ted in 6 children treated with Epinastine and 7 treated with Ketotifen.<BR>Conclusion: The near-equivalenc e of Epinastine and Ketotifen was proved. Epinastine and Ketotifen were both well tolerated in treating children with perennial allergic rhinitis.

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