Fabbri Natalia Zanellato, Abib Eduardo, de Lima Zollner Ricardo
Department of Internal Medicine, Faculty of Medical Sciences, University of Campinas, Sao Paulo, Brazil.
Allergy Rhinol (Providence). 2014 Jul;5(2):78-86. doi: 10.2500/ar.2014.5.0089. Epub 2014 Jul 1.
The aim of this study was to objectively evaluate the effects of intranasal therapy with azelastine (AZE), budesonide (BUD), and combined AZE plus BUD (AZE/BUD) using a nasal provocation test (NPT) and acoustic rhinometry in patients with allergic rhinitis. A randomized, single-blind, crossover study with three treatment sequences was used. Thirty patients with persistent AR received the three treatments using a nasal spray twice daily for 30 days and were evaluated by an NPT with histamine before and after each period of treatment. The treatment comparison, assessed by the nasal responsiveness to histamine, was monitored based on subjective (symptom score) and objective parameters (acoustic rhinometry). The minimal cross-area 2 (MCA2) was measured by acoustic rhinometry at 1, 4, 8, and 12 minutes after NPT for each histamine concentration administered (0.5, 1, 2, 4, and 6 mg/mL) up to at least a 20% reduction in the MCA2 from baseline (NPT20). The subjects were scored regarding nasal response encompassing histamine dose and time after histamine administration that caused nasal obstruction (NPT20 score) to assess the treatments' effects. Combination therapy produced a significant increase in baseline MCA2, viz., the improvement of nasal patency (p = 0.005). The symptoms score was significantly decreased after treatment with AZE (p = 0.03), BUD (p < 0.0001), and AZE/BUD (p < 0.0001), compared with pretreatment. The NPT20 score was significantly higher (p = 0.0009) after AZE/BUD, compared with AZE and BUD on their own. Thus, AZE therapy combined with BUD might provide more therapeutic benefits than the isolated drugs for improving nasal patency.
本研究旨在通过鼻激发试验(NPT)和声反射鼻测量法,客观评估氮卓斯汀(AZE)、布地奈德(BUD)以及AZE联合BUD(AZE/BUD)鼻内治疗对变应性鼻炎患者的疗效。采用了具有三种治疗顺序的随机、单盲、交叉研究。30例持续性变应性鼻炎患者接受这三种治疗,每天两次使用鼻喷雾剂,持续30天,并在每个治疗期前后通过组胺NPT进行评估。基于主观(症状评分)和客观参数(声反射鼻测量法),通过鼻对组胺的反应性评估治疗效果。在给予每种组胺浓度(0.5、1、2、4和6mg/mL)的NPT后1、4、8和12分钟,通过声反射鼻测量法测量最小横截面积2(MCA2),直至MCA2较基线至少降低20%(NPT20)。根据包括组胺剂量和组胺给药后导致鼻塞的时间在内的鼻反应对受试者进行评分(NPT20评分),以评估治疗效果。联合治疗使基线MCA2显著增加,即鼻通畅度得到改善(p = 0.005)。与治疗前相比,AZE(p = 0.03)、BUD(p < 0.0001)和AZE/BUD(p < 0.0001)治疗后症状评分显著降低。与单独使用AZE和BUD相比,AZE/BUD治疗后的NPT20评分显著更高(p = 0.0009)。因此,与单独使用药物相比,AZE联合BUD治疗可能在改善鼻通畅度方面提供更多治疗益处。