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Efficacy and safety of fluticasone furoate nasal spray in Chinese adult and adolescent subjects with intermittent or persistent allergic rhinitis

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机构: [1]Beijing Inst Otolaryngol, Minist Educ China, Key Lab Otolaryngol Head & Neck Surg, Beijing 100005, Peoples R China [2]Capital Med Univ, Beijing TongRen Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China [3]Sichuan Univ, W China Hosp, Dept Otolaryngol Head & Neck Surg, Chengdu 610064, Peoples R China [4]Shanghai Jiao Tong Univ, Renji Hosp, Dept Otolaryngol Head & Neck Surg, Shanghai 200030, Peoples R China [5]Fudan Univ, Dept Otolaryngol, Eye & Ear Hosp, Shanghai 200433, Peoples R China [6]Wuhan Union Hosp, Dept Otolaryngol Head & Neck Surg, Wuhan, Peoples R China [7]Zhejiang Univ, Affiliated Hosp 1, Dept Otolaryngol Head & Neck Surg, Hangzhou 310003, Zhejiang, Peoples R China [8]Nanjing Med Univ, Dept Otolaryngol, Jiangsu Prov Hosp, Nanjing, Jiangsu, Peoples R China
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Fluticasone fiiroate nasal spray (FFNS) is a novel, enhanced-affinity intranasal corticosteroid administered for the management of allergic rhinitis (AR). Several studies have shown that FFNS at a dose of 110 mu g once daily (o.p.d.) is effective in relieving nasal as well as ocular symptoms in adolescents and adults with AR. The primary objective of this study was to compare the efficacy and safety of PENS 110 micrograms o.p.d. with matching placebo nasal spray for 2 weeks in Chinese adult and adolescent subjects with intermittent AR (JAR) or persistent AR (PAR). In this multicenter, randomized, double-blind, placebo-controlled, parallel-group study, patients (adults and adolescents aged >= 12 years with AR) received either FFNS 110 micrograms (n = 181) or placebo (n = 182) o.p.d. for 2 weeks. AR was defined according to Allergic Rhinitis and Its Impact on Asthma classification. Efficacy measures included reflective total nasal symptom score (rTNSS), rhinoscopy score, overall interference in activities of daily living (ADL) score, and reflective total ocular symptom score (rTOSS). PENS significantly improved the mean change from baseline in daily rTNSS compared with placebo (treatment difference of -1.498, 95% confidence interval [-1.897, -1.099]; p < 0.0001). FFNS was also significantly more effective than placebo in decreasing rhinoscopy score (treatment difference of -1.3; p < 0.0001) and ADL score (treatment difference of -0.4; p < 0.0001). In patients with severe ocular symptoms, FENS showed numerically better treatment effect in reducing daily rTOSS than placebo (treatment difference of -0.646; p = 0.0853). FFNS 110 micrograms o.p.d. was significantly more effective than placebo in improving nasal symptoms in Chinese patients with JAR and PAR. ClinicalTrials.gov registration number: NCT01231464. (Allergy Asthma Proc 32:472-481, 2011; doi: 10.2500/aap.2011.32.3474)

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出版当年[2010]版:
大类 | 4 区 医学
小类 | 4 区 过敏
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大类 | 3 区 医学
小类 | 4 区 过敏
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第一作者机构: [1]Beijing Inst Otolaryngol, Minist Educ China, Key Lab Otolaryngol Head & Neck Surg, Beijing 100005, Peoples R China [2]Capital Med Univ, Beijing TongRen Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
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通讯机构: [1]Beijing Inst Otolaryngol, Minist Educ China, Key Lab Otolaryngol Head & Neck Surg, Beijing 100005, Peoples R China [2]Capital Med Univ, Beijing TongRen Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China [*1]Beijing Inst Otolaryngol, Minist Educ China, Key Lab Otolaryngol Head & Neck Surg, 17 HouGouHuTong, Beijing 100005, Peoples R China
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