左西替利嗪与西替利嗪治疗慢性荨麻疹多中心随机双盲对照研究

A Multi-center Randomized Double-blind Comparative Clinical Trial of Levocetirizine and Cetirizine for the Treatment of Chronic Idiopathetic Urticaria

目的研究和比较左西替利嗪和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、对照临床研究。试验组盐酸左西替利嗪片每日1次,每次5mg,对照组盐酸西替利嗪片每日1次,每次10mg,均连续服用28d。分别于用药后第7、14、28天随访,观察疗效和不良反应。结果入选病例132例,可评价疗效和安全性病例均为130例。ITT分析左西替利嗪组治疗后第7、14、28天有效率分别为73.44%、82.81%、89.06%,西替利嗪组有效率分别为77.27%、81.82%、81.82%,两组比较差异无显著性。左西替利嗪组和西替利嗪组不良反应发生率分别为14.06%和18.18%,主要有口干、嗜睡。结论左西替利嗪治疗慢性荨麻疹安全有效。

Objective To investigate and compare the effect and safety of levocetirizine and cetirizine for the treatment of chronic idiopathetic urticaria (CIU). Methods A multi-center, randomized and double-blind comparative clinical trial was employed. The patients with CIU were divided into levocetirizine group and cetirizine group. Levocetirizine (5mg/day) or cetirizine (10mg/day) were taken once daily for 28 days, and were followed up on the 7th day, 14th day and 28th day after starting treatment. Results One hundred and thirty cases were evaluable for the effect and safety at the end of the study. The effective rates in levocetirizine group and in cetirizine group were 73.44% and 77.27% on the 7th day after treatment, 82.81% and 81.82% on the 14th day, and 89.06% and 81.82% at the end of the therapy respectively. There was no significant difference between the two groups. The drug adverse reaction for levocetirizine group and cetirizine group were 14.06% and 18.18% respectively, which include mouth dryness, dizziness etc. Conclusion Levocetirizine is an effective and safe agent for the treatment of CIU.