国产盐酸西替利嗪治疗荨麻疹和过敏性鼻炎的多中心验证研究

A multicentre compared study of domestic cetirizine hydrochloride in the treatment of urticaria and allergic rhinitis

摘要: 目的: 评价国产盐酸西替利嗪治疗荨麻疹和过敏性鼻炎的临床疗效和安全性。方法: 采用随机双盲、阳性药平行对照、多中心Ⅱ期临床研究, 对国产盐酸西替利嗪和仙特明 10mg、每天 1次口服进行比较。结果: 14d治疗后, 试验组临床有效率 94.37%, 对照组 90.63%, 二组疗效无显著差异。二组均无严重的药物不良反应。结论: 国产盐酸西替利嗪和国外同类产品仙特明治疗荨麻疹和过敏性鼻炎, 在总的疗效和安全性方面无明显差异。

Abstract: Objective:To evaluate the efficacy and safety of domestic cetirizine HCL in the treatment of patients with urticaria and allergic rhinitis. Methods: A multicentre, randomized, doubl-blind, parallel compared study was used to compare the efficacy and safety of cetirizine HCL or zyrtec 10mg tablet, orally, once daily in the treatment of patients with urticaria and allergic rhinitis. Results: After 14 day, the efficacy rates were 94.37% for cetirizine HCL vs. 90.63% for zyrtec, the difference of efficacy rates in two groups was no statistically significant. There were no serious adverse drug reactions in the clinical trial. Conclusions: The efficacy and safety of domestic cetirizine HCL are similar to zyrtec.