Service des Maladies Respiratoires, Hôpital Arnaud de Villeneuve, Montpellier, and INSERM UMR 780, Villejuif, France.
Department of Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium.
Allergy. 2009 Oct;64(10):1516-1523. doi: 10.1111/j.1398-9995.2009.02115.x. Epub 2009 Jul 14.
The Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines proposed a classification for allergic rhinitis based on the duration of symptoms (intermittent, persistent) rather than on the time of allergen exposure (seasonal, perennial). There is no placebo-controlled, randomized clinical trial on intermittent allergic rhinitis (IAR) to date. Desloratadine (DL) is recommended for the first-line treatment of seasonal and perennial allergic rhinitis.
To assess the efficacy and safety of DL in subjects with IAR based on the ARIA classification.
Patients over 12 years of age with IAR were assessed over 15 days of treatment with DL 5 mg once daily (n = 276) or placebo (n = 271). The primary endpoint was the AM/PM reflective total 5 symptom score (T5SS). Secondary endpoints included AM/PM instantaneous T5SS and individual symptoms, therapeutic response, symptom severity by visual analogue scale, and quality-of-life.
The mean reduction of AM/PM reflective T5SS was significantly greater with DL than with placebo over 15 days (-3.01 vs-2.13, P < 0.001) and on each individual day (P < 0.05). Mean AM instantaneous T5SS was reduced significantly with DL compared to placebo as early as day 2 (-1.84 vs-0.89; P < 0.001). The therapeutic response and improvement in quality-of-life were significantly greater with DL than with placebo (P < 0.001 for each). The frequency of treatment-related adverse events was low and similar between DL (7.2%) and placebo (7.0%).
This is the first large trial to show that treatment can be effective in IAR. Desloratadine was effective and safe.
变应性鼻炎及其对哮喘的影响（ARIA）指南提出了一种基于症状持续时间（间歇性、持续性）而非过敏原暴露时间（季节性、常年性）的变应性鼻炎分类方法。迄今为止，尚无针对间歇性变应性鼻炎（IAR）的安慰剂对照、随机临床试验。地氯雷他定（DL）被推荐用于季节性和常年性变应性鼻炎的一线治疗。
根据 ARIA 分类评估 DL 在 IAR 患者中的疗效和安全性。
对 12 岁以上 IAR 患者进行为期 15 天的治疗，每日一次给予 DL 5mg（n=276）或安慰剂（n=271）。主要终点是 AM/PM 反射性总 5 症状评分（T5SS）。次要终点包括 AM/PM 即时 T5SS 和个别症状、治疗反应、视觉模拟量表评估的症状严重程度以及生活质量。
与安慰剂相比，DL 在 15 天内（-3.01 对-2.13，P<0.001）和每天（P<0.05）均可显著降低 AM/PM 反射性 T5SS。与安慰剂相比，DL 可更早地显著降低 AM 即时 T5SS（第 2 天-1.84 对-0.89；P<0.001）。DL 的治疗反应和生活质量改善均显著优于安慰剂（每项 P<0.001）。DL 与安慰剂组的治疗相关不良事件发生率低且相似（分别为 7.2%和 7.0%）。
这是第一项表明治疗可有效治疗 IAR 的大型试验。地氯雷他定有效且安全。
