国产地洛他定治疗变应性鼻炎有效性及安全性的临床研究

Study on efficacy and safety of Desloratadine in the treatment of allergic rhinitis

目的 :评估国产地洛他定治疗变应性鼻炎的有效性和安全性。方法 :采用随机双盲、多中心、氯雷他定平行对照的临床研究 ,190例完成本研究。结果 :地洛他定组总有效率和显效率分别为 88.30 %、73.4 0 % ,氯雷他定组为 85 .4 2 %、6 5 .6 3% ,差别无统计意义 (P >0 .0 5 )。不良反应发生率地洛他定组和氯雷他定组分别为 8.5 %和 17.7% (P >0 .0 5 ) ,主要为轻度和短暂的嗜睡、口干和头痛。结论 :两种药物治疗变应性鼻炎疗效相似 ,但地洛他定的不良反应少于氯雷他定。国产地洛他定片治疗变应性鼻炎疗效可靠、安全性好。

Objective:To evaluate the efficacy and safety of Desloratadine in treating allergic rhinitis(AR).Methods:A double-blind,multicenter,randomized,comparative study versus Loratadine was carried out.A total of 190 subjects were involved in the trial.Results:The efficacy of Desloratadine was 88.30%,and the excellent rate was 73.40%,while the efficacy of Loratadine was 85.42%,and the excellent rate was 65.63%.The incidences of adverse reaction assessment (ADR) of Desloratadine and Loratadine were 8.5% and 17.7% respectively.Adverse reactions mainly included mild or moderate drowsiness,dry mouth,and headache.Conclusion:The efficacy of Desloratadine and Loratadine is similar in the treatment of AR. The incidences of ADR in Desloratadine group are less than that in Loratadine group.National Desloratadine is effective and safe for allergic rhinitis.