中华皮肤科杂志 ›› 2009, Vol. 42 ›› Issue (4): 285-286.

• 药物与临床 • 上一篇    下一篇

依匹斯汀与左西替利嗪治疗慢性荨麻疹多中心随机双盲对照研究

闫毅,曾海   

  1. 江西省赣州市皮肤病医院
  • 收稿日期:2008-05-04 修回日期:2008-05-27 出版日期:2009-04-15 发布日期:2009-04-14
  • 通讯作者: 闫毅
  • 基金资助:

A multicenter, randomized, double-blind, controlled study on the efficacy of epinastine vs levocetirizine in chronic urticaria

  • Received:2008-05-04 Revised:2008-05-27 Online:2009-04-15 Published:2009-04-14

摘要:

目的:研究和比较依匹斯汀和左西替利嗪治疗慢性荨麻疹的疗效和安全性。方法:选择慢性荨麻疹患者为研究对象,采用多中心、随机、双盲、双模拟和对照临床研究。试验组依匹斯汀胶囊每日1次,每次10mg,对照组盐酸左西替利嗪胶囊每日1次,每次5mg,均连续服用28天。于用药后随访,观察疗效和不良反应。结果:入选病例131例,可评价疗效和安全性病例120例。经28天治疗后依匹斯汀组及左西替利嗪组总有效率分别为70.05%、67.79%,两组比较差异无显著性(P=0.2564)。依匹斯汀组和左西替利嗪组不良反应发生率分别为11.48%和23.33%。结论:依匹斯汀治疗慢性荨麻疹安全有效。

Abstract:

objective: To investigate and compare the effect and safety of epinastine and levocetirizine for the treatment of chronic urticaria (CU).Methods: A randomized, double-blind, double-dummy, multicenter, parallel control clinical trial was employed.The patients with CU were divided into epinastine group and levocetirizine group.Epinastine (10mg/day)or levocetirizine (5mg/day) were taken once daily for 28 days,and were followed up on the 28th day after starting treatment. Results: One hundred and twenty cases were evaluable for the effect and safety at the end of the study. The effective rates in epinastine group and in levocetirizine group were 70.05% and 67.79%.There was no significant difference between the two groups(P=0.2564). The drug adverse reaction for epinastine group and levocetirizine group were 11.48% and 23.33% respectively. Conclusion: Epinastine is an efficient and safe antihistaminic drug on treating chronic urticaria.

Key words: Epinastine; levocetirizine; Urticaria; randomized controlled trials; double-blind method