LaForce Craig F, Corren Jonathan, Wheeler William J, Berger William E
Carolina Allergy and Asthma Consultants, Raleigh, North Carolina 27607, USA.
Ann Allergy Asthma Immunol. 2004 Aug;93(2):154-9. doi: 10.1016/S1081-1206(10)61468-8.
Currently available oral second-generation antihistamines do not provide adequate symptom relief for many allergy patients.
To determine the ability of azelastine nasal spray to improve rhinitis symptoms in patients with seasonal allergic rhinitis who remained symptomatic after treatment with fexofenadine.
This was a multicenter, randomized, double-blind, placebo-controlled, 2-week study in patients with moderate-to-severe seasonal allergic rhinitis. The study began with a 1-week, open-label lead-in period, during which patients received fexofenadine, 60 mg twice daily. Patients who improved less than 25% to 33% with fexofenadine were randomized to treatment with (1) azelastine nasal spray, 2 sprays per nostril twice daily; (2) azelastine nasal spray, 2 sprays per nostril twice daily, plus fexofenadine, 60 mg twice daily; or (3) placebo (saline) nasal spray and placebo capsules twice daily. The primary efficacy variable was the change from baseline to day 14 in the total nasal symptom score (TNSS), consisting of runny nose, sneezing, itchy nose, and nasal congestion symptom scores.
A total of 334 patients who remained symptomatic after treatment with fexofenadine were included in the efficacy analysis. After 2 weeks of treatment, azelastine nasal spray (P = .007) and azelastine nasal spray plus fexofenadine (P = .003) significantly improved the TNSS compared with placebo. Azelastine nasal spray monotherapy was as effective as the combination of azelastine nasal spray plus fexofenadine as measured by the TNSS and individual symptoms of the TNSS.
Azelastine nasal spray is effective monotherapy for patients who remain symptomatic after treatment with fexofenadine and should be considered in the initial management of patients with seasonal allergic rhinitis.
目前可用的口服第二代抗组胺药不能为许多过敏患者提供足够的症状缓解。
确定氮卓斯汀鼻喷雾剂对在使用非索非那定治疗后仍有症状的季节性变应性鼻炎患者改善鼻炎症状的能力。
这是一项针对中重度季节性变应性鼻炎患者的多中心、随机、双盲、安慰剂对照的2周研究。研究开始时有1周的开放标签导入期，在此期间患者每天两次服用60毫克非索非那定。使用非索非那定改善不足25%至33%的患者被随机分配接受以下治疗：（1）氮卓斯汀鼻喷雾剂，每侧鼻孔每天两次，每次2喷；（2）氮卓斯汀鼻喷雾剂，每侧鼻孔每天两次，每次2喷，加非索非那定，每天两次，每次60毫克；或（3）安慰剂（盐水）鼻喷雾剂和安慰剂胶囊，每天两次。主要疗效变量是从基线到第14天总鼻症状评分（TNSS）的变化，该评分由流涕、打喷嚏、鼻痒和鼻塞症状评分组成。
共有334例在使用非索非那定治疗后仍有症状的患者纳入疗效分析。治疗2周后，与安慰剂相比，氮卓斯汀鼻喷雾剂（P = .007）和氮卓斯汀鼻喷雾剂加非索非那定（P = .003）显著改善了TNSS。根据TNSS及其个体症状测量，氮卓斯汀鼻喷雾剂单药治疗与氮卓斯汀鼻喷雾剂加非索非那定联合治疗效果相同。
氮卓斯汀鼻喷雾剂对在使用非索非那定治疗后仍有症状的患者是有效的单药治疗方法，在季节性变应性鼻炎患者的初始治疗中应予以考虑。
