氯雷他定片治疗变应性鼻炎的临床疗效观察

目的:评价氯雷他定片治疗变应性鼻炎的疗效和安全性.方法:将140例变应性鼻炎患者随机分为治疗组、对照组各70例.治疗组给予氯雷他定片(商品名:开瑞坦),对照组给予咪唑斯汀缓释片(商品名:皿治林)治疗.两组均治疗28天后观察疗效.结果:对总体疗效而言,意向性分析(ITT)结果显示两组总有效率(痊愈率+显效率)分别为71.43%、70.00%,方案数据分析(PP)结果显示两组总有效率(痊愈率+显效率)分别为74.24%、76.19%,疗效差异均无统计学意义,P＞0.05,两组具有临床上的非劣性,P＜0.05.ITT分析与PP分析结果一致.临床观察中未发现明显不良反应.结论:氯雷他定片治疗变应性鼻炎安全有效,值得在临床上推广应用.

Clinical effective study of Loratadine Tablets for treatment of allergic rhinitis

Objective：To assess the efficacy and safety of Loratadine（clarityne） Tablets in the treatment of allergic rhinitis.Methods： 140 patients of allergic rhinitis were randomly divided into treatment group and control group,70 patients in each group.The treatment group was treated with loratadine （clarityne）,and control group with Mizolastine Sustained-Release Tablet.28 d later,their therapeutic effects were observed.Results：All the results were analyzed on the basis of intention-to-treat and per-protocol population,the total effective rate was 71.43% or 74.24% in the treatment group and 70.00% or 76.19% in the control group with the no significant difference between the two groups,P0.05.The efficacy between two groups was noninferiority,P0.05.ITT and PP analysis revealed similar results.No adverse effect was found in the observation.Conclusion：Loratadine （clarityne） Tablets is effeclive and safe in the treatment of allergic rhinitis and worth popularizing in clinic.