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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 .6 3% ,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。
Objective: To evaluate the clinical efficacy and safety of domestic cetirizine hydrochloride in the treatment of urticaria and allergic rhinitis. Methods: Randomized double-blind, positive drug parallel control, multi-center phase Ⅱ clinical study of domestic cetirizine hydrochloride and cents Temin 10mg, 1 times a day for oral comparison. Results: After 14 days of treatment, the clinical effective rate was 94.37% in the experimental group and 90.63% in the control group, with no significant difference between the two groups. No severe adverse drug reactions in both groups. Conclusion: Domestic cetirizine hydrochloride and similar foreign products Xian Teming treatment of urticaria and allergic rhinitis, no significant difference in overall efficacy and safety.