在常年性变应性鼻炎中，0.15%氮卓斯汀和糠酸莫米松对鼻结膜炎生活质量问卷（RQLQ）的改善效果相似。
In perennial allergic rhinitis, RQLQ is improved similarly by Azelastine 0.15 and mometasone furoate.
作者信息
Bousquet Jean, Klimek Ludger, Kuhl Hans-Christian, Nguyen Duc Tung, Kumar Ramalingam Rajesh, Canonica G Walter, Berger William E
机构信息
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany.
Institute of Allergology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
出版信息
World Allergy Organ J. 2025 Jan 8;18(1):101021. doi: 10.1016/j.waojou.2024.101021. eCollection 2025 Jan.
UNLABELLED
Some double-blind, placebo-controlled trials have shown that Azelastine (Aze) high dose (0.15%) was effective in seasonal (SAR) and perennial allergic rhinitis (PAR). However, there was no long-term comparison between Aze 0.15% and intranasal corticosteroids (INCS) on safety and quality of life in perennial allergic rhinitis.An open-label, active-controlled, parallel-group one-year study comparing mometasone furoate and Aze 0.15% in adults assessed safety over 1 year. Efficacy using the 28-item rhino-conjunctivitis quality of life questionnaire (RQLQ) was a secondary end point.A total of 703 patients were randomized and 687 (97.7%) were included in the intent-to-treat (ITT) population. The present formulation was shown to be safe with long-term use over 12 months, with a mean duration of exposure of 270.7 days.Over the one-year period, there was no significant difference for any RQLQ domains between Aze and mometasone furoate (MF) for all evaluations (baseline, 6, 9, and 12 months). This study suggests that Aze 0.15% and MF display a similar improvement of RQLQ ( 2.80 [2.78] for Aze 0.15% vs 2.81 [2.75] for MF).
CLINICAL TRIAL REGISTRY NUMBER
NCT00720382.
未标注
一些双盲、安慰剂对照试验表明，高剂量（0.15%）氮卓斯汀（Aze）对季节性变应性鼻炎（SAR）和常年性变应性鼻炎（PAR）有效。然而，在常年性变应性鼻炎中，0.15%氮卓斯汀与鼻内皮质类固醇（INCS）在安全性和生活质量方面尚无长期比较。一项开放标签、活性药物对照、平行组的为期一年的研究，比较了糠酸莫米松和0.15%氮卓斯汀在成人中的安全性，评估了1年的安全性。使用28项鼻结膜炎生活质量问卷（RQLQ）评估疗效为次要终点。共有703例患者被随机分组，687例（97.7%）纳入意向性治疗（ITT）人群。目前的制剂显示长期使用12个月是安全的，平均暴露时间为270.7天。在一年期间，对于所有评估（基线、6个月、9个月和12个月），氮卓斯汀和糠酸莫米松（MF）在任何RQLQ领域均无显著差异。这项研究表明，0.15%氮卓斯汀和MF在RQLQ改善方面表现相似（0.15%氮卓斯汀为2.80[2.78]，MF为2.81[2.75]）。
临床试验注册号
NCT00720382。
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