Efficacy and safety of beclomethasone dipropionate nasal aerosol in pediatric patients with seasonal allergic rhinitis
Efficacy and safety of beclomethasone dipropionate nasal aerosol in pediatric patients with seasonal allergic rhinitis
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DOI：
10.1016/j.anai.2013.07.033
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发表时间：
2013-11-01
影响因子：
5.9
通讯作者：
Tantry, Sudeesh K.
中科院分区：
文献类型：
--
作者：
Storms, William W.;Segall, Nathan;Tantry, Sudeesh K.
背景：鼻腔雾化皮质类固醇制剂对于许多变应性鼻炎(AR)患者，尤其是儿童来说是可取的，他们希望避免与含水制剂相关的“湿感”和“滴入喉咙”。目的：评价二丙酸倍氯米松(BDP)鼻喷雾剂治疗儿童中重度季节性AR的疗效和安全性。方法：采用双盲、安慰剂对照研究，将6~11岁季节性AR患儿随机分为BDP鼻雾剂80 mg(n=239)、160 mg(n=242)或安慰剂(n=234)，每日1次。结果：与安慰剂组比较，BDP鼻雾剂治疗后早晚反射性鼻部症状平均评分显著改善(80mUg，-0.71；160mug，-0.76；P<；.001)。同样，与安慰剂组相比，服用BDP鼻腔喷雾剂的患者早晨和晚上的鼻部症状总评分为显著改善(80微克，-0.63；160微克，-0.73；P<；.001)。结论：BDP鼻雾剂(80或160 mg/d)可显著缓解鼻部症状，且总体安全性与安慰剂相似，是一种有效且耐受性良好的治疗儿童季节性中重度AR的方法。
Background: Aerosolized intranasal corticosteroid formulations are desirable for many patients with allergic rhinitis (AR), especially children, who wish to avoid the "wet feeling" and "drip down the throat" associated with aqueous formulations. Beclomethasone dipropionate (BDP) hydrofluoroalkane nasal aerosol has been shown to be safe and effective in adolescents and adults with AR.Objective: To evaluate the efficacy and safety of BDP nasal aerosol in pediatric patients with moderate to severe seasonal AR.Methods: In this double-blinded, placebo-controlled study, children (6-11 years of age) with seasonal AR were randomized to once-daily treatment with BDP nasal aerosol 80 mu g (n = 239) or 160 mg (n = 242) or placebo (n = 234). The primary end point was change from baseline in average morning and evening reflective total nasal symptom score over the 2-week treatment period.Results: Treatment with BDP nasal aerosol showed significantly greater improvements in average morning and evening reflective total nasal symptom score vs placebo (80 mu g, -0.71; 160 mu g, -0.76; P < .001 for the 2 comparisons). Similarly, significantly greater improvements in average morning and evening instantaneous total nasal symptom score were seen with BDP nasal aerosol vs placebo (80 mu g, -0.63; 160 mu g, -0.73; P < .001 for the 2 comparisons). The incidence of adverse events from BDP nasal aerosol was comparable to that from placebo.Conclusion: BDP nasal aerosol (80 or 160 mu g/d) provided significant and clinically meaningful nasal symptom relief and an established overall safety profile similar to that of placebo, suggesting that it is an effective and well-tolerated treatment option for pediatric patients with moderate to severe seasonal AR.