盐酸氮斯汀与氯雷他定随机对照治疗变应性鼻炎的临床试验  

Randomized controlled clinical trial on azelastine hydrochloride tablet versus loratadine in the treatment of allergic rhinitis

作　　者：黄魏宁[1] 张雷[1] 许辉杰[1] 梁莺[1] 韩东一[2] 冯勃[2] 王凯[2] 张晓凡[2] 肖水芳[3] 刘志贤[3] 王全桂[3] 

机构地区：[1]卫生部北京医院耳鼻咽喉一头颈外科,北京100730 [2]中国人民解放军总医院耳鼻咽喉头颈外科,北京100853 [3]北京大学第一临床医院耳鼻咽喉-头颈外科,北京100034

出　　处：《中国临床药理学杂志》2004年第2期88-91,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的 与对照药氯雷他定片比较,评价盐酸氮(?)斯汀片治疗变应性鼻炎的临床疗效及安全性。方法 用多中心、随机、双盲、平行对照的临床试验,试验组变应性鼻炎病人58例,每日服用盐酸氮(?)斯汀片2次,每次1 mg;对照组病人63例,每日口服氯雷他定片1 0 mg和安慰剂各1次。两组均连续服药14天。对治疗前后的喷嚏、流涕、鼻堵、鼻痒及鼻腔情况进行评分。结果 盐酸氮革斯汀片和氯雷他定片治疗变应性鼻炎的有效率分别为87.93％,82.54％;药物不良反应发生率分别为8.62％,14.06％。经统计学检验,两者差异均无显著性。 结论 盐酸氮(?)斯汀片治疗变应性鼻炎安全有效。Objective To evaluate the efficacy and safety of azelastine hydrochloride tablet in allergic rhinitis in compare with loratadine. Methods A multicenter randomized doubl-blind and parallel-controlled clinical trail was conducted. Patients with mild to moderate allergic rhinitis received either azelastine hydrochloride tablet 1 mg twice daily or placebo tablet and loratadine tablet 10 mg each once daily for consecutive 14 days. Nasal symptom score, consisting of sneezing, runny nose, itchy nose, nasal congestion and nasal cavity condition scores was recored before, during and after the treatment. Results The total effective rate was 87.93% for azelastine group and 82.54% for loratadine group, and the adverse event rate was 8.62% and 14.06%, respectively. There was no statistical significant between the two groups. Conclusion Azelastine hydrochloride tablet was effective and safe for the treatment of allergic rhinitis.

关 键 词：盐酸氮zhuó斯汀 氯雷他定 随机对照 治疗 变应性鼻炎 临床试验 

分 类 号：R765.21[医药卫生—耳鼻咽喉科]