Johns Hopkins Asthma & Allergy Center, Baltimore, MD, USA.
Clin Exp Allergy. 2010 May;40(5):738-44. doi: 10.1111/j.1365-2222.2010.03466.x. Epub 2010 Mar 12.
Although nasal challenge with allergen has often been used to evaluate the efficacy of therapeutic modalities used for the treatment of allergic rhinitis, the reproducibility of this model in quantitatively evaluating efficacy has not been rigorously examined.
To examine the reproducibility of the suppressive effects of an intranasal corticosteroid on the clinical and biochemical outcomes of a nasal allergen challenge during two identical treatment periods using the same subjects.
In a single-blind study, 25 seasonal allergic subjects with positive skin tests to grass or ragweed were studied outside of their pollen season. Subjects underwent a baseline, three-dose allergen challenge. Beginning 1 week later, subjects received two 7-day courses of intranasal beclomethasone (168 microg b.i.d.) separated by a 1-month washout period. Nasal challenges with allergen were performed after each treatment period. The nasal allergic response was evaluated by counting sneezes, recording symptom scores and measuring levels of albumin (an index of vascular permeability), lysozyme (an index of serous glandular secretion) and kinins (proinflammatory peptides) in recovered nasal lavages.
Compared with the baseline challenge, each course of beclomethasone significantly reduced sneezing, symptom scores, albumin and kinins, but not lysozyme. Reproducibility analysis of the net changes from diluent challenge in the two beclomethasone treatment periods, showed the following intraclass correlation coefficients: sneezing (0.92), lysozyme (0.82), symptom scores (0.72), albumin (0.64) and kinins (0.28).
We conclude that the nasal challenge model is a reproducible method to evaluate the efficacy of anti-allergic medications. For nasal corticosteroid trials, sneezing, symptom scores and albumin levels are recommended as the most reproducibly suppressive outcome measures.
虽然鼻内过敏原挑战常用于评估治疗变应性鼻炎的治疗方法的疗效，但尚未严格检查该模型在定量评估疗效方面的可重复性。
用相同的受试者在两个相同的治疗期内，通过鼻内皮质类固醇对鼻内过敏原挑战的临床和生化结果的抑制作用的可重复性。
在一项单盲研究中，25 名对草或豚草皮肤试验呈阳性的季节性过敏患者在花粉季节之外进行了研究。患者接受了基线、三剂量过敏原挑战。一周后，患者开始接受两个为期 7 天的鼻腔内用倍氯米松（168μg b.i.d.）治疗，间隔一个月的洗脱期。每个治疗期后都进行过敏原鼻内挑战。通过打喷嚏计数、记录症状评分和测量回收的鼻灌洗液中的白蛋白（血管通透性指数）、溶菌酶（浆液腺分泌指数）和激肽（促炎肽）水平来评估鼻过敏反应。
与基线挑战相比，每个倍氯米松疗程均显著减少打喷嚏、症状评分、白蛋白和激肽，但不减少溶菌酶。在两个倍氯米松治疗期从稀释剂挑战的净变化的重复性分析中，显示以下组内相关系数：打喷嚏（0.92）、溶菌酶（0.82）、症状评分（0.72）、白蛋白（0.64）和激肽（0.28）。
我们得出结论，鼻挑战模型是评估抗变应性药物疗效的一种可重复的方法。对于鼻皮质类固醇试验，推荐打喷嚏、症状评分和白蛋白水平作为最可重复的抑制性测量结果。
