Efficacy of Desloratadine in Persistent Allergic Rhinitis - A GA2LEN Study
Efficacy of Desloratadine in Persistent Allergic Rhinitis - A GA2LEN Study
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DOI：
10.1159/000316351
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发表时间：
2010-01-01
影响因子：
2.8
通讯作者：
Zuberbier, Torsten
中科院分区：
文献类型：
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作者：
Bousquet, Jean;Bachert, Claus;Zuberbier, Torsten
背景：ARIA(变应性鼻炎及其对哮喘的影响)指南建议根据症状的持续时间(间歇性或持续性)而不是过敏原暴露的时间(季节性或常年性)对变应性鼻炎进行分类。到目前为止，还没有关于地洛他定(DL)在持续性变应性鼻炎患者中的安慰剂对照、随机临床试验。目的：根据ARIA分类评价丹参滴鼻剂治疗持续性变应性鼻炎的疗效和安全性。方法：对年龄在12岁以上的持续性变应性鼻炎患者进行为期85天的评估，用DL5 mg每日1次(n=360)或安慰剂(n=356)治疗。主要终点是AM/PM反射性总5症状评分(T5SS)，平均为1-29天。次要终点包括AM/PM瞬时T5SS和个别症状、治疗反应、症状严重程度的视觉模拟评分和生活质量。结果：在第1-29天(-3.76vs.-2.87p<；0.001)和每一天(p<；0.05)，服用DL的患者AM/PM反射性T5SS的平均下降显著大于安慰剂组(p<；0.05)。与安慰剂组相比，服用丹参酮的患者第2天AM瞬时T5SS显著降低(-1.9比-1.46；p<；0.001)。DL组的疗效和生活质量的改善显著高于安慰剂组(P<；各0.001)。与治疗相关的不良事件的发生率很低，在DL(10.0%)和安慰剂(8.4%)之间相似。结论：丹参口服液治疗持续性变应性鼻炎安全有效。版权所有(C)2010 S.Karger AG，巴塞尔
Background: The ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines proposed a classification for allergic rhinitis based on the duration of symptoms (intermittent or persistent) rather than on the time of allergen exposure (seasonal or perennial). There had been no placebo-controlled, randomized, clinical trial of desloratadine (DL) in patients with persistent allergic rhinitis to date. Objectives: To assess the efficacy and safety of DL in patients with persistent allergic rhinitis based on the ARIA classification. Methods: Patients 12 years of age and older with persistent allergic rhinitis were assessed over 85 days of treatment with DL 5 mg once daily (n = 360) or placebo (n = 356). The primary endpoint was the AM/PM reflective total 5-symptom score (T5SS) averaged over days 1-29. Secondary endpoints included AM/PM instantaneous T5SS and individual symptoms, therapeutic response, symptom severity assessed by a visual analogue scale and quality of life. Results: The mean reduction in AM/PM reflective T5SS was significantly greater with DL than placebo over days 1-29 (-3.76 vs. -2.87, p < 0.001) and on each individual day (p < 0.05). The mean AM instantaneous T5SS was significantly reduced with DL compared with placebo as early as day 2 (-1.90 vs. -1.46; p < 0.001). The therapeutic response and improvement in quality of life were significantly greater with DL than placebo (p < 0.001 for each). The frequency of treatment-related adverse events was low and similar between DL (10.0%) and placebo (8.4%). Conclusions: This study showed DL to be effective and safe in the treatment of persistent allergic rhinitis. Copyright (C) 2010 S. Karger AG, Basel