地洛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：评价地洛他定治疗慢性特发性荨麻疹的有效性及安全性。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。试验组口服地洛他定，对照组口服氯雷他定。均为l片／次，1次／d，连续服用14d。分别于用药后第1、2周随访，2周末评价疗效与不良反应。结果：入组患者116例，可评价疗效与安全性例数分别为111例和116例。试验组与对照组的总有效率分别为91．23％和90．74％（P〉0．05）。两组的不良反应发生率分别为20．69％和16．36％（P〉0．05）。结论：地洛他定治疗慢性特发性荨麻疹安全、有效，与氯雷他定相当。

Efficacy and safety of desloratadine in the treatment of chronic idiopathic urticaria: a double-blind, randomized, comparative multicenter trial

Objective: To study the efficacy and safety of desloratadine in chronic idiopathic urticaria(CIU). Methods: This study was a randomized, double-blind, double-analog comparative multicenter trial of 2 weeks'duration. Patients were randomly allocated to receive either desloratadine (n=58) or loratadine one tablet (n=58) once-daily for 14 days, and followed up at 7th day and 14th day after treatment. Results: Of the 116 patients who enrolled the study, 111 cases and 116 cases could be evaluated the efficacy and safety respectively. The total response rates of desloratadine and loratadine were 91.23% and 90.74% , respectively(P>0.05). The adverse reactions rates were 20.69% and 16.36%(P>0.05). Conclusion: Both desloratadine and loratadine are well tolerated and effective in the treatment of CIU.