Paz Lansberg Marianella, DeTineo Marcy, Lane James, Pinto Jayant M, Baroody Fuad M, Naclerio Robert M
Section of Otolaryngology-Head and Neck Surgery, Department of Surgery, The University of Chicago Medicine and Biological Sciences, Chicago, Illinois, USA.
Am J Rhinol Allergy. 2016 Jul;30(4):269-73. doi: 10.2500/ajra.2016.30.4314.
Allergic rhinitis is a common disorder that leads to a negative impact on quality of life. Multiple options are available for treatment of the symptoms, but preventing the reaction should be an effective strategy.
We tested a nasal spray that contained microcrystalline cellulose designed to limit airborne allergens from penetrating the nasal mucosa (nasal blocker) and, therefore, prevent the initiation of the allergic reaction.
We performed a randomized, double-blind, placebo-controlled, two-way crossover clinical trial with 20 subjects who had a history of seasonal grass and/or ragweed allergy symptoms. Each subject underwent two separate nasal challenges with antigen (provocations) after application of the investigational product or placebo to both nostrils. The allergen was delivered into one nostril at a time and was administered at 2-hour intervals (identified as challenge 1 and challenge 2). We assessed peak nasal inspiratory flow and total nasal symptoms as well as the number of sneezes recorded at both 15-minute and 1-hour intervals after challenge 1 and, later, challenge 2. After a washout period, the subjects returned to undergo the alternate therapy.
There was a significant overall decrease in peak nasal inspiratory flow after both treatments (investigational product, p = 0.005; placebo, p = 0.001), but, when the average of the change from baseline in peak nasal inspiratory flow was compared with the baseline, the results showed no significant differences between the groups (p = 0.31). Similar results were obtained for total nasal symptoms.
The investigational product did not prove to be significantly better than placebo in treating seasonal allergic rhinitis symptoms.
变应性鼻炎是一种常见疾病，会对生活质量产生负面影响。治疗症状有多种选择，但预防反应应是一种有效策略。
我们测试了一种含有微晶纤维素的鼻喷雾剂，其设计目的是限制空气中的过敏原穿透鼻黏膜（鼻阻断剂），从而预防过敏反应的发生。
我们对20名有季节性草和/或豚草过敏症状病史的受试者进行了一项随机、双盲、安慰剂对照、双向交叉临床试验。在向两个鼻孔应用研究产品或安慰剂后，每个受试者接受两次单独的抗原鼻激发试验。过敏原一次注入一个鼻孔，每隔2小时给药一次（分别为激发试验1和激发试验2）。我们在激发试验1后15分钟和1小时以及激发试验2后评估鼻吸气峰值流量、总鼻部症状以及记录的喷嚏次数。经过洗脱期后，受试者返回接受替代治疗。
两种治疗后鼻吸气峰值流量均有显著总体下降（研究产品组，p = 0.005；安慰剂组，p = 0.001），但将鼻吸气峰值流量相对于基线的变化平均值与基线进行比较时，结果显示两组之间无显著差异（p = 0.31）。总鼻部症状也得到了类似结果。
在治疗季节性变应性鼻炎症状方面，研究产品并未证明比安慰剂有显著更好的效果。
