氮斯汀喷鼻剂治疗常年性变应性鼻炎随机双盲试验

Azelastine nasal spray in treating perennial allergic rhinitis: a randomly double-blind trial

目的 :探讨氮斯汀喷鼻剂治疗常年性变应性鼻炎的疗效及安全性。方法 :38例中、重度常年性变应性鼻炎病人行随机、双盲、对照研究。分氮斯汀组 19例 ,给予氮斯汀液体喷鼻剂喷鼻 ,每日 2次 ,每次每侧鼻孔 1揿 (每揿 140 μg氮斯汀 ) ,治疗 4wk。左卡巴斯汀组 19例 ,用左卡巴斯汀喷鼻剂喷鼻 ,每日 2次 ,每次 2揿 ,作为对照。治疗 2wk末及 4wk末时 ,根据主观评分及客观检查结果 ,综合评定疗效。结果 :氮斯汀喷鼻剂组总有效率为 95 % ,左卡巴斯汀喷鼻剂组为 84 % (P >0 .0 5 )。 2组治疗前后喷嚏、流涕、鼻痒、鼻塞及眼部症状积分下降分别为 1.4± 0 .8和 1.3± 1.0 ,1.0±0 .7和 0 .8± 0 .9,1.3± 0 .6和 1.4± 0 .7,0 .7± 0 .7和 0 .7± 0 .8,0 .8± 0 .8和 0 .5± 0 .7(均P >0 .0 5 ) ,未发生严重的不良反应。结论

AIM: To evaluate the therapeutic efficacy and safety of azelastine nasal spray in treating perennial allergic rhinitis. METHODS: Thirty-eight patients with moderate to severe perennial allergic rhinitis were qualified for the random, double-blind, comparative research. They were divided into two groups: azelastine group (nineteen patients) was treated with azelastine nasal spray, one puff per nostril twice daily for 4 wk (one puff=140 μg azelastine), and levocabastine group (nineteen patients) was treated with levocabastine nasal spray 2 puff per nostril twice daily as the control. At the end of 2 wk and 4 wk treatment, the comprehensine evaluation of effect was made according to the subjective symptom score and objective examination. RESULTS: The total effect rate was 95 %, and 84 %, in azelastine group and in the levocabastine group, respectively (P> 0.05). The differences of symptom score (pre-treatment score-post-treatment score) of sneezing, discharge, itching of nose and nasal blockage between the two groups decieased and those were 1.4±0.8 and 1.3±1.0, 1.0±0.7 and 0.8±0.9, 1.3±0.6 and 1.4±0.7, 0.7±0.7 and 0.7±0.8, 0.8±0.8 and 0.5±0.7, respectively (P>0.05). No remarkable adverse reaction was observed. CONCLUSION: Azelastine nasal spray has similar therapeutic efficacy and tolerability to levocabastine nasal spray in the treatment of perennial allergic rhinitis.