西替伪麻缓释片治疗季节性或常年性过敏性鼻炎的临床研究

Efficacy and safety of cetirizine-pseudoephedrine sustained-release tablets in the treatment of seasonal and perennial allergic rhinitis

目的:评价西替伪麻缓释片治疗季节性或常年性过敏性鼻炎疗效和安全性。方法:按照随机、双盲、双模拟盐酸西替利嗪对照设计,将210例受试者按1∶1随机分配至西替伪麻缓释片组和盐酸西替利嗪胶囊组,进行系统性的临床试验研究。结果:服药7 d时的鼻塞、流涕、鼻痒程度评分改善,疾病总体严重程度和总体改善的评价分析中,试验组较对照组改善的更好,差别有统计学意义。与对照组相比不良事件发生率差别无统计意义。无严重不良事件发生。结论:西替伪麻缓释片是一种安全、有效的治疗季节性或常年性过敏性鼻炎的药物,值得推广使用。

Objective： To investigate the efficacy and safety of compound cetirizine hydrochloride and pseudoephedrine hydroehloride sustained-release tablets in the treatment of seasonal and perennial allergic rhinitis. Methods： In a randomized, double-blind, double-dummy and controlled trial, 210 patients were randomly assigned to the cetirizine-pseudoephedrine sustained-release tablet group and cetirizine hydrochloride capsules （con- trol） group to conduct a systematic research. Results： After 7-day treatments, the scores of nasal blockage, runny nose, nasal itching and the overall severity of the disease were significantly reduced, and the efficacy of cetirizinepseudoephedrine tablets was better than control capsules. The incidence of adverse events was not significantly different, and no serious adverse events occurred in both groups. Conclusion： Cetirizine-pseudoephedrine sustainedrelease tablet is a safe and effective drug in the treatment of seasonal or perennial allergic rhinitis.