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非索非那定与西替利嗪随机对照治疗变应性鼻炎的临床试验
引用本文:杨桦,邓安春,镡旭民,周世文,李明红. 非索非那定与西替利嗪随机对照治疗变应性鼻炎的临床试验[J]. 中国新药与临床杂志, 2005, 24(10): 802-805
作者姓名:杨桦  邓安春  镡旭民  周世文  李明红
作者单位:1. 中国人民解放军第三军医大学新桥医院,耳鼻咽喉科,重庆,400037
2. 中国人民解放军第三军医大学新桥医院,国家药品临床研究基地,重庆,400037
摘    要:目的:比较非索非那定与西替利嗪治疗变应性鼻炎的疗效及安全性。方法:采用多中心、随机、双盲双模拟、平行对照的临床试验。试验组变应性鼻炎病人68例,用非索非那定片,120mg,po,qd;对照组病人72例,用西替利嗪片,10mg,po,qd。2组均连续服药14d。对治疗前后病人的喷嚏、流涕、鼻塞、鼻痒及鼻腔情况进行评分。结果:试验组和对照组治疗变应性鼻炎的有效率分别为99%,93%;药物不良反应发生率分别为22%,25%。2组差异均无显著意义(P>0.05)。结论:非索非那定治疗变应性鼻炎安全有效,与西替利嗪相仿。

关 键 词:西替利嗪  鼻炎,变应性,常年性  随机对照试验  双盲法  多中心研究  非索非那定
文章编号:1007-7669(2005)10-0802-04
收稿时间:2004-11-11
修稿时间:2004-11-112005-06-03

Randomized controlled clinical trial on fexofenadine versus cetirizine in treatment of allergic rhinitis
YANG Hua,DENG An-chun,CHAN Xu-min,ZHOU Shi-wen,LI Ming-hong. Randomized controlled clinical trial on fexofenadine versus cetirizine in treatment of allergic rhinitis[J]. Chinese Journal of New Drugs and Clinical Remedies, 2005, 24(10): 802-805
Authors:YANG Hua  DENG An-chun  CHAN Xu-min  ZHOU Shi-wen  LI Ming-hong
Affiliation:1. Department of Otolaryngology, Xinqiao Hospital, the Third Military Medical University of PLA , CHONGQING 400037, China; 2. Base for Clinical Pharmacology, Xinqiao Hospital, the Third Military Medical University of PLA, CHONGQING 400037, China
Abstract:AIM: To evaluate the efficacy and safety of fexofenadine comparing with cetirizine in allergic rhinitis. METHODS: A multicenter randomized double-blind and parallel-controlled clinical trail wa s conducted.Patients with mild to moderate allergic rhinitis received either fexof enadine 120 mg,po,qd,for 68 patients or cetirizine 10 mg,po,qd,in 72 patients for consecutive 14 d. Nasal sym ptom scores, consisiting of sneezing,runny nose, itchy nose, nasal congestion a nd nasal cavity condition were recorded before, during and after the treamemt. RESULTS: The total effective rates and adverse reaction rates for fexofenadine group and cetirizine group were 99 % vs 93 % and 22 % vs 25 %, r espectively. There was no statistical significant between the two groups. CONC LUSION: Fexofenadine is effective and safe for the treatm ent of allergic rhinitis.
Keywords:cetirizine   rhinitis, allergic, pe-rennial   randomized controlled trials    double-blind method    multicenter studies    fexofenadine
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