Unit Ex vivo/in vitro Models to Study Immunopathology and Pharmacology of Airway Diseases, Institute of Biomedicine and Molecular Immunology, Italian National Research Council, Palermo, Italy.
Int Arch Allergy Immunol. 2013;161(1):53-64. doi: 10.1159/000343137. Epub 2012 Dec 14.
We aimed to evaluate the therapeutic effect of nebulized beclomethasone dipropionate (nBDP) on both allergic asthma and rhinitis. In a randomized, double-blind, placebo-controlled study, 40 children (mean age 10.7 ± 2.1 years) with allergic asthma and rhinitis received either nBDP (daily dose of 800 µg, administered twice daily) or placebo for 4 weeks (with a face mask), after a 2-week run-in period of clinical assessment. Nasal and oral fractional exhaled nitric oxide (FeNO) measurements together with pulmonary function tests, nasal and oral exhaled breath condensate (EBC) collection for pH and interleukin-5 (IL-5) measurements as well as nasal and bronchial symptom scores were obtained at baseline and after 4-week treatment. A significant improvement in oral FeNO, oral and nasal EBC IL-5 and nasal EBC pH was observed in the nBDP group when comparing the values with baseline, together with an improvement in symptom score of the visual analogue scale, nasal obstruction, sneezing, rhinorrhea, breathing difficulty, cough, wheezing and sleep disturbance (nBDP end treatment vs. baseline, Wilcoxon signed-rank test). nBDP was more effective than placebo (ANCOVA test) in improving [difference Δ = response after treatment at the last visit (active or placebo) - value at baseline] nasal pH, oral IL-5, oral FeNO, forced expiratory volume in 1 s, forced expiratory volume in 1 s/forced vital capacity, peek expiratory flow, visual analogue scale, breathing difficulty, cough, wheezing and sleep disturbance scores. No differences were observed between the nBDP and the placebo group for symptom score of rhinitis. nBDP is a useful treatment for airway inflammation and clinical status in children with concomitant allergic asthma and rhinitis.
我们旨在评估吸入用二丙酸倍氯米松(nBDP)对过敏性哮喘和鼻炎的治疗效果。在一项随机、双盲、安慰剂对照研究中,40 名(平均年龄 10.7 ± 2.1 岁)过敏性哮喘和鼻炎患儿在为期 2 周的临床评估预适应期后,分别接受 nBDP(每日剂量 800µg,每日 2 次)或安慰剂治疗 4 周(使用面罩)。在基线和 4 周治疗后,进行鼻和口腔呼出的一氧化氮分数(FeNO)测量,以及肺功能测试、鼻和口腔呼出气冷凝液(EBC)采集以测量 pH 值和白细胞介素-5(IL-5)以及鼻和支气管症状评分。与基线相比,nBDP 组的口腔 FeNO、口腔和鼻腔 EBC 的 IL-5 和鼻腔 EBC 的 pH 值均显著改善,同时视觉模拟量表的症状评分、鼻阻塞、打喷嚏、流鼻涕、呼吸困难、咳嗽、喘息和睡眠障碍也得到改善(nBDP 治疗结束时与基线相比,Wilcoxon 符号秩检验)。nBDP 在改善[差异 Δ=最后一次就诊(活性或安慰剂)时的治疗后反应-基线值]鼻腔 pH 值、口腔 IL-5、口腔 FeNO、1 秒用力呼气量、1 秒用力呼气量/用力肺活量、峰值呼气流量、视觉模拟量表、呼吸困难、咳嗽、喘息和睡眠障碍评分方面比安慰剂更有效(协方差分析测试)。在鼻炎症状评分方面,nBDP 组和安慰剂组之间没有差异。nBDP 是一种治疗儿童同时患有过敏性哮喘和鼻炎的气道炎症和临床状况的有效方法。