地洛他定和氯雷他定治疗慢性特发性荨麻疹多中心双盲对照临床试验

目的　观察地洛他定治疗慢性特发性荨麻疹效果及安全性。方法　采用多中心、双盲、双模拟阳性对照研究 ,随机分为试验组和对照组。地洛他定 5mg/次 ,氯雷他定 10mg/次 ,均 1次 /d ,连续服用 2 8天 ,分别于用药后第 1、2、4周随访 ,观察疗效和不良反应。结果　入组例数 2 17例 ,可评价疗效及安全性例数分别为 2 11例和 2 12例。试验组和对照组服药后第 1周疗效分别为 2 3 .81%和 3 2 .0 8% ,第 2周分别为 62 .86%和 5 9.43 % ,第 4周疗效分别为 88.78%和83 .0 2 %。两组不良反应发生率分别为 11.3 2 %和 13 .2 1% ,主要有口干、嗜睡、头痛等。结论　地洛他定治疗慢性特发性荨麻疹安全有效。

A Multiple-centre Double-blind Comparative Clinical Trial of Desloratadine and Loratadine for the Treatment of Chronic Idiopathetic Urticaria

Objective To investigate the effect and safety of desloratadine for the treatment of chronic idiopathetic urticaria(CIU).Methods A multiple-centre,double-blind,double-analog comparative clinical trial was employed.The patients diagnosed as CIU clearly by clinical signs were divided into desloratadine group and loratadine group randomly.Desloratadine(5 mg/day) or loratadine(10 mg/day) was taken by once-day for 28days,and follow-ups were done at 7th day,14th day and 28th day after treatment.Results 217 cases were involved.Among them,211 cases and 212 cases were reliable for effective and safe evaluation respectively.The effective rates of desloratadine group and loratadine group were 23.81% and 32.08% at 7th day,62.86% and 59.43% at 14th day after treatment,and 88.78% and 83.02% by the end of treatment respectively. The advert rates of desloratadine group and loratadine group were 11.32% and 13.21% respectively.The main side effects include mouth dryness,dizziness and headache etc.Conclusion Desloratadine is an effective and safe agent for treatment of CIU.