您的位置:山东大学 -> 科技期刊社 -> 《山东大学学报(医学版)》

山东大学学报(医学版)

• 论文 • 上一篇    下一篇

盐酸非索非那定胶囊治疗季节性变应性鼻炎多中心双盲对照临床试验

雷大鹏1,林国经2,李学忠1,许风雷1,潘新良1   

  1. 1. 山东大学齐鲁医院耳鼻喉科,山东 济南 250012;2.福建医科大学附属协和医院耳鼻喉科,福建 福州 350001;3.青岛市立医院耳鼻喉科,山东 青岛 266011;4.山东大学齐鲁医院皮肤科,山东 济南 250012
  • 收稿日期:2005-11-19 修回日期:1900-01-01 出版日期:2006-08-24 发布日期:2006-08-24
  • 通讯作者: 雷大鹏

Effect of fexofenadine hydrochloride sustained capsule for seasonal allergic rhinitis: a doubleblind, randomized, comparative multicenter trial

LEI Da-peng,LI Xue-zhong,XU Feng-lei,PAN Xin-liang,LIN Guo-jing,XUE Wei-guo,LI Chun-yang   

  1. 1. Department of Otorhinolaryngology, Qilu Hospital of Shandong University, Jinan 250012,Shandong, China; 2. Department of Otorhinolaryngology, Union Hospital, Fujian Medical University, Fuzhou 350001, Fujian, China;
  • Received:2005-11-19 Revised:1900-01-01 Online:2006-08-24 Published:2006-08-24
  • Contact: LEI Da-peng

摘要: 目的:评价盐酸非索非那定胶囊治疗季节性变应性鼻炎的有效性和安全性。方法:采用多中心、随机、双盲、双模拟、阳性药物平行对照临床试验方法,随机分为试验组和对照组。试验组口服盐酸非索非那定胶囊(60?mg/粒),对照组口服二盐酸西替利嗪(10?mg/粒),每天早、晚各1次,连续服用2周。用药后第1周、第2周随访,2周末评价疗效与不良反应。结果:入组140例,试验组71例,对照组69例。完成137例,脱落3例,其中试验组2例,对照组1例;可评价疗效与安全性例数分别为137例和140例。试验组和对照组的总有效率分别为66.20%和68.12%,不良反应的发生率组间比较差异无统计学意义(P>0.05)。结论:盐酸非索非那定胶囊治疗季节性变应性鼻炎疗效可靠,使用安全,与二盐酸西替利嗪相当。

Abstract: To study the efficacy and safety of fexofenadine hydrochloride sustained capsule in treating seasonal allergic rhinitis. Methods: A randomized, doubleblind, doubleanalog comparative multicenter trial was performed on 140 patients, who were randomly given either fexofenadine hydrochloride (n=71) or cetirizine dihydrochloride (n=69) one tablet in the morning and one in the night. After a followup on the 7 th day anthe 14 th day, the efficacy and adverse response were monitored at the end of the 2 weeks. Results: Of the 140 patients, 137 or 140 could be evaluated the efficacy or safety, respectively. The total response rate of fexofenadine hydrochloride and cetirizine dihydrochloride was 66.20% and 68.12%, respectively(P>0.05). No statistical difference of the adverse reactions was found between the two groups(P>0.05). Conclusion: Both fexofenadine hydrochloride and cetirizine dihydrochloride are well tolerated and effective in the treatment of seasonal allergic rhinitis.

Key words: Hay fever, Clinical trials, Fexofenadine hydrochloride

No related articles found!
Viewed
Full text


Abstract

Cited

  Shared   
  Discussed   
No Suggested Reading articles found!