F/P F/P VAS. 2 fexofenadine pseudoefedrine F/P F/P F/P. dust mite HDM 17. fexofenadine pseudoefedrine F/P F/P

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1 JJIAO 35 1 : 1 6, 2017 原 著 / NPO 2 fexofenadine pseudoefedrine F/P F/P F/P F/P VAS F/P F/P F/P, fexofenadine/pseudoephedrine; VAS, visual analogue scale 2 fexofenadine pseudoefedrine F/P F/P ) TEL: yosuken@med.tottori-u.ac.jp F/P F/P 2) VAS 1 16 house dust mite HDM 17 IgE MAST33 HDM Japan Society of Immunology & Allergology in Otolaryngology

2 2 / VAS 3 90% 90% CIWilcoxon VAS 90%CI t p<0.05 Excel IgE 3.1 ± ± VAS F/P mg 60 mg MPR ) 100 Pa 2 Visual Analogue Scale 10 numerical rating scale VAS ± VAS ± F/P 8 17 ± 298±112 cm 3 /s 407±148 cm 3 /s 90% CI p= ±7.8 ±SD 11.2 ±7.1 ±SD 3.9±1.9 ±SD

3 JJIAO 2017: ± 4 F/P VAS ± VAS 4 F/P 5 F/P 7 90 ± 389±127.9 cm 3 /s 90% CI p= F/P 4 4 F/P 8 VAS ± 3.8± ±2.1 90%CI p= ± 3.1±1.8 90% CI p= DNP-ascaris 4)

4 4 / 3 90% F/P 90 8 * p<0.05 vs ** p<0.01 vs *** p<0.001 vs Wilcoxon 4 F/P 13 4 F/P 3 5 VAS 90% VAS F/P * p<0.05 vs ** p<0.01 vs *** p<0.001 vs paired t 5) F/P F/P II/III F/P 6) F/P F/P 1 F/P

5 JJIAO 2017: F/P 3 1 F/P 30 Total Nasal Symptom Score: TNSS 7) 2 F/P 45 8) 3 F/P 2 QOL 9) F/P Berkowitz 6 8) F/P 8 F/P 6 Keyser 10) nasal cycle 1 nasal cycle 11,12) 12) F/P 4 F/P 28 F/P 13) 207±92.5 ng/ml 315±126 ng/ml F/P / 1 8 VAS 2 8 / 1) ) 2016; 55(1): ) Rhinomanometry 2001; 40(4): ) 2003; 23(2): ) Rudolph K, Bice ED, et al. A model of allergic nasal congestion in dogs sensitized to ragweed. Am J Rhinol. 2003; 17(4): ) II/III 2012; 19(11): ) / OHIO Chamber 2015; 22(1): ) Berkowitz RB, McCafferty F, et al. Onset of action of fexofenadine hydrochloride 60 mg/pseudoephedrine hydrochloride 120 mg in subjects aged 12 years with moderate to severe seasonal allergic rhinitis: A pooled analysis of two single-dose, randomized, doubleblind, placebo-controlled allergen exposure unit studies. Clin Ther. 2006; 28(10): ) Moinuddin R, de Tineo M, et al. Comparison of the combinations of fexofenadine-pseudoephedrine and loratadine-montelukast in the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2004; 92(1): ) Keyser R. Die exacte messing der luftdurchgangigkeit der nase. Arch Laryngol. 1895; 3: ) Hasegawa M, Kern EB, et al. Dynamic change of nasal resistance. Ann Otol Rhinol Laryngol. 1979; 88(1 Pt 1): ) nasal cycle 2000; 46 3 : S ) 2014www.info.pmda.go.jp/go/ pack/ f1021_1_03/

6 6 / Evaluation of efficacy of Fexofenadine/Pseudoephedrine combination tablet on patients with perennial allergic rhinitis: Evaluation by rhinomanometry Yosuke Nakamura 1, Hiromi Takeuchi 1, Kei Fukushima 2, Yuko Yokoyama 1, Rie Morizane 1, Tadao Enomoto 3 1 Department of Otolaryngology, Head and Neck Surgery, Faculty of Medicine, Tottori University 2 Department of Otolaryngology, Head and Neck Surgery, National Hospital Organization Fukuyama Medical Center 3 NPO Japan Promotion Supporting Network ABSTRACT Background: A Fexofenadine/Pseudoephedrine combination tablet (F/P) is a novel product containing fexofenadine hydrochloride, a histamine H1-receptor antagonist for sneezing and rhinorrhea and pseudoephedrine hydrochloride, an α adrenergic agonist for nasal obstruction. The effect to the nasal obstruction of the F/P is confirmed empirically. But, there are few reports that the effect of the F/P to nasal obstruction was considered objectively. In the present study, we estimated the efficacy of the drug on nasal obstruction for patients with allergic rhinitis. Method: Seventeen subjects (12 males and 5 females, aged years) with perennial allergic rhinitis were recruited for the study. Each subject was measured for the patency by anterior rhinomanometry and the sensation of it by Visual Analogue Scale (VAS) scores. Nasal airflow and VAS scores were recorded at 30 minute intervals for 4 hours before dosing and for 8 hours after dosing as a single drug therapy. The efficacy was onset of action, assessed in terms of absolute change from baseline before dosing. Result: Subjects mean age was 28.6 and 70.6% were male. The onset of action of F/P was 1.5 hours, significant improvement in nasal airflow from baseline was detected with the mean change of 79.4 cm 3 /s (90% CI, ; p=0.001). All subsequent changes from baseline in nasal airflow were statistically significant for F/P. The absolute in VAS scores were decreased at all time points from 2 hours after administering. Conclusion: In this study, we found out that F/P is effective about an immediate effect and the continuation to nasal obstruction of perennial allergic rhinitis. Key words: fexofenadine, pseudoefedrine, nasal obstruction, allergic rhinitis, rhinomanometry