依巴斯汀治疗慢性特发性荨麻疹的临床试验研究

A double-blinded, randomized, parallel-controlled study on the safety and efficacyof ebastine for the treatment of chronic idiopathic urticaria

目的:评估国产依巴斯汀治疗慢性特发性荨麻疹的临床疗效和安全性。方法:采用随机、双盲、平行对照的方法对依巴斯汀治疗慢性荨麻疹进行Ⅱ期临床试验,并与西替利嗪进行对照。结果:共观察患者136例,依巴斯汀组69例,西替利嗪组67例,依巴斯汀组的有效率和显效率分别为91.3%和63.8%,而西替利嗪组分别为87.9%和65.2%,两组间比较差异均无显著性(P>0.05)。依巴斯汀组症状积分下降指数为0.79±0.26,而西替利嗪组为0.76±0.29,两组间比较差异无显著性(P>0.05)。两种药物的不良反应主要为轻至中度困倦和口干。结论:依巴斯汀治疗慢性特发性荨麻疹安全有效,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. Methods: A randomized, double-blinded, parallel-controlled clinical trial was conducted in 136 subjects. Sixty-nine cases were in ebastine group, and 67 were in cetirizine group. All patients received the drug (ebastine or cetirizine 10mg) one tablet once a day for 14 days. Results: The response rates (improved and marked improved) of ebastine were 91.3% and 63.8%,and those of cetirizine were 87.9% and 65.2% respectively. Symptom score reducing index(SSRI)of ebastine group and cetirizine group were 0.79±0.26 and 0.76±0.29 respectively. They all showed no statistical difference between the two groups (P > 0.05). No serious adverse events were observed in the two groups. The main adverse reactions were mild to moderate drowsiness and dry mouth in the two groups. It also showed no statistical difference between the two groups (P > 0.05). Conclusions: These results suggest that ebastine is an efficacious and safe drug in the treatment of chronic idiopathic urticaria. Its efficacy and safety are similar to those of cetirizine.