Andersson M, Svensson C, Persson C, Akerlund A, Greiff L
Department of Otorhinolaryngology, University Hospital Lund, Sweden.
Ann Allergy Asthma Immunol. 2000 Oct;85(4):279-83. doi: 10.1016/S1081-1206(10)62530-6.
It has been difficult to demonstrate dose-dependent clinical effects of anti-allergic glucocorticosteroid drugs in allergic rhinitis.
To determine dose-dependent effects on rhinitis symptoms of clinical doses of the glucocorticosteroid budesonide in a standardized daily allergen challenge model.
Twenty-five patients with seasonal allergic rhinitis were examined outside the pollen season. The highest 256 microg once daily and lowest 64 microg once daily clinically recommended doses of budesonide aqueous nasal spray and placebo were given in a double-blind, placebo-controlled, randomized, and crossover design with 4 weeks' washout between treatments. After 1 week's treatment, the patients received individually titrated nasal allergen challenges once every morning for 8 days while treatment continued. Nasal symptoms were scored in diary cards. Nasal symptoms from the 6th to the 8th challenge days were used in the analysis.
The provocation model produced clinically relevant, and around the clock well tolerable rhinitis symptoms, suggesting that after several days of repeated allergen challenges, a season-like, transient allergic disease condition had been established. Both 64 microg and 256 microg of budesonide aqueous nasal spray reduced nasal symptoms. Budesonide 64 microg reduced total nasal symptoms scores from 5.19 +/- 0.5 to 4.23 +/- 0.53 (P < .05), and budesonide 256 microg reduced total nasal symptoms scores to 3.41 +/- 0.51 (P < .001). A significant difference in nasal symptoms after challenge between budesonide aqueous nasal spray 64 microg and 256 microg (P = .03), indicated a dose-dependent effect.
A dose-dependent, symptom-reducing effect of once-daily treatment with topical aqueous nasal sprays of budesonide for two weeks was demonstrated, suggesting that this model is relevant for assessments of dose-dependent effects of anti-inflammatory drugs.
一直以来，在变应性鼻炎中难以证明抗变应性糖皮质激素药物存在剂量依赖性临床效果。
在标准化每日变应原激发模型中确定临床剂量的糖皮质激素布地奈德对鼻炎症状的剂量依赖性效应。
在花粉季节之外对25例季节性变应性鼻炎患者进行检查。采用双盲、安慰剂对照、随机交叉设计，给予布地奈德水鼻喷雾剂临床推荐的最高剂量每日一次256微克和最低剂量每日一次64微克以及安慰剂，各治疗之间有4周的洗脱期。治疗1周后，患者在治疗持续期间每天早晨接受一次个体化滴定的鼻变应原激发，共8天。在日记卡上对鼻症状进行评分。分析第6至8天激发日的鼻症状。
激发模型产生了具有临床相关性且全天耐受性良好的鼻炎症状，这表明在数天的重复变应原激发后，建立了类似季节的短暂变应性疾病状态。64微克和256微克的布地奈德水鼻喷雾剂均减轻了鼻症状。64微克布地奈德使总鼻症状评分从5.19±0.
