富马酸依美斯汀缓释片治疗过敏性鼻炎的有效性和安全性  

Study on efficacy and safety of Emedastine Difumarate Sustained- release Tablets in treatment of allergic rhinitis

作　　者：庄婕[1] 晁磊[2] 王淑华[1] 

机构地区：[1]山东省生物药物研究院,山东济南250100 [2]山东大学附属济南市中心医院,山东济南250013

出　　处：《药学研究》2013年第8期482-484,共3页Journal of Pharmaceutical Research

摘　　要：目的评价富马酸依美斯汀缓释片治疗过敏性鼻炎的有效性和安全性,并与市售的富马酸氯马斯汀缓释片进行对照。方法采用多中心、随机、双盲双模拟、阳性药平行对照的临床试验。结果经过两周治疗,两组临床控制率试验组11.11%,对照组18.06%,组间比较无统计学意义(P>0.05);显效率试验组81.94%,对照组75.00%,组间比较无统计学意义(P>0.05)。PP分析结果与FAS分析结果一致。不良反应:两组病人用药后不良反应发生率A组8例占11.11%,B组9例占12.50%。组间比较差异无统计学意义(P=1.000 0)。结论富马酸依美斯汀缓释片治疗过敏性鼻炎安全有效。Objective To evaluate the efficacy and safety of Emedastine Difumarate Sustained - release Tablets in the treatment of allergic rhinitis with commercial Clemastine Fumarate Sustained - release Tablets as control. Methods A mul- ticenter, randomized, double - blind, double dummy, positive - controlled trial was adopted. Results After 2 weeks of treat- ment, the clinical control rate and efficiency were respectively 11.11% , 81.94% for emedastine difumarate group and 18. 06% ,75.00% for clemastine fumarate group. And the differences between the groups were not statistically significant in clinical control rate and efficiency（P 〉 0.05）. PP analysis and FAS analysis showed the consistent results. Adverse reac- tion：the incidence of adverse events was 11.11% for 8 cases in a group and 12.50% for 9 cases in B group,respectively. The difference between the both groups was not statistically significant （ P = 1. 000 0 ）. Conclusion Emedastine Difumarate Sustained - release Tablets can be safe and effective in the treatment of allergic rhinitis.

关 键 词：富马酸依美斯汀缓释片 富马酸氯马斯汀缓释片 过敏性鼻炎 

分 类 号：R969.4[医药卫生—药理学]