盐酸奥洛他定在中国变应性鼻炎人群的非劣效临床研究设计及其定量分析  

Efficacy and safety of olopatadine hydrochloride for allergic rhinitis in Chinese patients

作　　者：刘红霞[1] 杨娟[1] 盛玉成[1] 何迎春[1] 许羚[1] 郑青山[1] 

机构地区：[1]上海中医药大学药物临床研究中心,上海201203

出　　处：《中国新药杂志》2007年第18期1528-1533,共6页Chinese Journal of New Drugs

基　　金：上海重点学科建设项目(Y0302)

摘　　要：目的:通过非劣性设计,评价盐酸奥洛他定片剂治疗变应性鼻炎的安全性和有效性。方法:以盐酸氯雷他定片为对照,采用随机、双盲双模拟、多中心、平行对照、非劣效临床研究。两组各120例。试验组早晚各1次口服盐酸奥洛他定,每次5 mg;对照组早晨服用氯雷他定片10 mg。按双模拟方法编盲,以症状体征总积分下降值为主要疗效指标,非劣效标准(δ)设为1分,疗程2周。结果:用药后2周,两组各项症状明显改善,症状体征总积分和生活质量评估等级较用药前显著下降(P<0.01);作为主要疗效指标的症状总积分差值(FAS集),组间差值95%可信区间为[-0.260,0.880],即试验组不劣于对照组(P<0.05)。对照组有效率为61.5%,不良反应发生率为9.2%;试验组有效率62.4%,不良反应发生率为5.8%,组间差异无统计学意义(P>0.05)。结论:盐酸奥洛他定治疗变应性鼻炎疗效确切,不劣于对照药氯雷他定,患者耐受性好,未发现严重不良反应。Objective： To evaluate the efficacy and safety of olopatadine hydrochloride in the treatment of Chinese patients with allergic rhinitis. Methods： A randomized, double-blind, multicenter, parallel controlled, and non-inferiority trial was designed to compare the efficacy and safety of olopatadine hydrochloride （5 mg,bid） and loratadine （10 mg, qd） （n = 120）. The oral administration lasted two weeks. The main end points were the decreased values of total score of symptoms and physical signs （ TSS）. The margin of non-inferiority was set at 1. Results： After two weeks of treatment, the total score of symptoms and physical signs and the quality of life assessment in two groups decreased significantly in comparison with those before the treatment（P 〈0.01）. 95% CI of TSS was [ -0. 260, 0. 880] （P 〈 0.05） , and no significant differences were found between the two groups either in the efficacy rate （loratadine： 61.5% , olopatadine hydrochloride： 62.4% ） or the incidence of adverse reactions （loratadine： 9. 2% , olopatadine hydrochloride：5.8% ）. Conclusion： Olopatadine hydrochloride is non-inferior to loratadine, and well tolerated in the treatment of Chinese patients with allergic rhinitis.

关 键 词：盐酸奥洛他定 氯雷他定 变应性鼻炎 临床试验 非劣效试验 

分 类 号：R976[医药卫生—药品] R969.4[医药卫生—药学]