地洛他定片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 探讨地洛他定片治疗变应性鼻炎的有效性及安全性并作出初步评价 ,同时推荐临床给药剂量。方法 采用随机盲法、多中心、氯雷他定平行对照的临床研究。结果 共有 2 2 5例病人入组 ,地洛他定片可明显改善病人的临床症状。地洛他定组与氯雷他定组总有效率差别无统计学意义 (P >0 .0 5 )。未发现地洛他定片有严重的不良反应。副作用发生率为 1 3.3%,以口干居多 ,嗜睡、头晕其次 ,不良反应发生率两组比较差别无统计学意义 (P >0 .0 5 )。结论 两种药物治疗变应性鼻炎疗效和不良反应相似 ,国产地洛他定片治疗变应性鼻炎疗效可靠、安全性好。

Objective To preliminarily evaluate the safety and efficacy of the domestic desloratadine tablet and recommend its clinic doses. Methods A randomized, single-blind, multicenter, loratadine-controlled trial was performed. Results A total of 225 patients were involved in the trial. Desloratadine can obviously alleviate patients' clinic symptoms, with its effect similar to that of loratadine tablet. No serious adverse effects were found. The incidence rate of side effects was about 12.2%. Side effects mainly include dry mouth followed by drowsiness and dizziness. Safe indexes between desloratadine and loratadine were not significantly different. Conclusion The efficacy and incidence of desloratadine and loratadine are similar in treatment of allergic rhinitis. Domestic desloratadine tablet is effective and safe for allergic rhinitis.