Berger William, Hampel Frank, Bernstein Jonathan, Shah Shailen, Sacks Harry, Meltzer Eli O
Southern California Research, Mission Viejo 92691, USA.
Ann Allergy Asthma Immunol. 2006 Sep;97(3):375-81. doi: 10.1016/S1081-1206(10)60804-6.
In fall 2004, the first Azelastine Cetirizine Trial demonstrated statistically significant improvements in the total nasal symptom score (TNSS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores with the use of azelastine nasal spray vs oral cetirizine in patients with seasonal allergic rhinitis (SAR).
To compare the effects of azelastine nasal spray vs cetirizine on the TNSS and RQLQ scores in patients with SAR.
This 2-week, double-blind, multicenter trial randomized 360 patients with moderate-to-severe SAR to azelastine, 2 sprays per nostril twice daily, or cetirizine, 10-mg tablets once daily. The primary efficacy variable was the 12-hour reflective TNSS (rhinorrhea, sneezing, itchy nose, and nasal congestion). Secondary efficacy variables were individual symptom scores and the RQLQ score.
Azelastine nasal spray and cetirizine significantly improved the TNSS and individual symptoms compared with baseline (P < .001). The TNSS improved by a mean of 4.6 (23.9%) with azelastine nasal spray compared with 3.9 (19.6%) with cetirizine. Significant differences favoring azelastine nasal spray were seen for the individual symptoms of sneezing and nasal congestion. Improvements in the RQLQ overall (P = .002) and individual domain (P < or = .02) scores were greater with azelastine nasal spray. Both treatments were well tolerated.
Azelastine nasal spray and cetirizine effectively treated nasal symptoms in patients with SAR. Improvements in the TNSS and individual symptoms favored azelastine over cetirizine, with significant differences for nasal congestion and sneezing. Azelastine nasal spray significantly improved the RQLQ overall and domain scores compared with cetirizine.
2004年秋季，首个氮卓斯汀与西替利嗪试验表明，对于季节性变应性鼻炎（SAR）患者，使用氮卓斯汀鼻喷雾剂相较于口服西替利嗪，在总鼻症状评分（TNSS）和变应性鼻炎生活质量问卷（RQLQ）评分方面有统计学意义的显著改善。
比较氮卓斯汀鼻喷雾剂与西替利嗪对SAR患者TNSS和RQLQ评分的影响。
这项为期2周的双盲多中心试验将360例中重度SAR患者随机分为两组，一组使用氮卓斯汀，每侧鼻孔每日两次，每次2喷；另一组使用西替利嗪，每日1次，每次10毫克片剂。主要疗效变量为12小时反射性TNSS（鼻漏、打喷嚏、鼻痒和鼻塞）。次要疗效变量为个体症状评分和RQLQ评分。
与基线相比，氮卓斯汀鼻喷雾剂和西替利嗪均显著改善了TNSS和个体症状（P <.001）。氮卓斯汀鼻喷雾剂使TNSS平均改善4.6分（23.9%），而西替利嗪为3.9分（19.6%）。在打喷嚏和鼻塞的个体症状方面，氮卓斯汀鼻喷雾剂有显著优势。氮卓斯汀鼻喷雾剂在RQLQ总体评分（P =.002）和各个领域评分（P≤.02）方面的改善更大。两种治疗耐受性均良好。
氮卓斯汀鼻喷雾剂和西替利嗪均能有效治疗SAR患者的鼻部症状。TNSS和个体症状的改善方面，氮卓斯汀优于西替利嗪，在鼻塞和打喷嚏方面有显著差异。与西替利嗪相比，氮卓斯汀鼻喷雾剂显著改善了RQLQ总体评分和领域评分。
