依巴斯汀治疗慢性特发性荨麻疹及过敏性鼻炎

A multicenter,double-blind,randomized,parallel-controlled study on the safety and efficacy of ebastine for the treatment of chronic idiopathic urticaria and allergic rhinitis

目的 评价国产依巴斯汀治疗慢性特发性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、平行组对照的方法 ,对依巴斯汀进行Ⅱ期临床试验。依巴斯汀组 135例 ,其中慢性荨麻疹 6 9例 ,过敏性鼻炎 6 6例 ;西替利嗪 (对照 )组 132例 ,其中慢性荨麻疹 6 7例 ,过敏性鼻炎 6 5例 ;两组病人均每天 1次口服观察药 1片 (10mg) ,连续用药 14天。结果 依巴斯汀组的慢性荨麻疹、过敏性鼻炎的总有效率分别为 91 3%和 89 4 % ,而对照组分别为 87 9%和 84 6 % ,两组间均无显著差异 (P >0 0 5 )。两种药物的不良反应主要为轻、中度困倦和口干 ,两组间无显著差异 (P>0 0 5 )。结论 依巴斯汀治疗慢性特发性荨麻疹和过敏性鼻炎安全有效 ,其疗效及不良反应与西替利嗪相似。

Objective To evaluate the efficacy and safety of ebastine in the treatment of chronic idiopathic urticaria and allergic rhinitis.Methods A multicenter,randomized,double-blind,parallel-controlled clinical trial was conducted in 267 subjects.135 cases were in ebastine group,including 69 patients with chronic idiopathic urticaria and 66 with allergic rhinitis.132 cases were in cetirizine group,including 67 patients with chronic idiopathic urticaria and 65 with allergic rhinitis.All patients received the drug one tablet(10 mg)once a day for 14 days.Results The efficacy rates of ebastine in the treatment of chronic idiopathic urticaria and allergic rhinitis were 91.3% and 89.4%,and those of cetirizine were 87.9% and 84.6% respectively.They showed no statistical difference between the two groups( P> 0.05).No serious adverse events were reported in the two groups.The main adverse reactions were mild or moderate drousiness and dry mouth in both groups.They also showed no statistical difference ( P> 0.05).Conclusion These results suggest that ebastine is an efficacious and safe drug in the treatment of chronic idiopathic urticaria and allergic rhinitis.Its efficacy and safety are similar to those of cetirizine.