摘要
目的:对右布地奈德鼻喷雾剂治疗过敏性鼻炎的有效性和安全性进行评价,并与布地奈德鼻喷雾剂比较。方法:采用多中心、随机、开放、平行对照的临床试验,符合入选标准的过敏性鼻炎患者共222例,分成2组:右布地奈德组(试验组)110例,布地奈德组(对照组)112例。试验组给予右布地奈德鼻喷雾剂,25μg/喷,每次每个鼻孔2喷,早晚各1次;对照组给予布地奈德鼻喷雾剂,64μg/喷,每次每个鼻孔1喷,早晚各1次。2组均连续用药14d。疗效评价以症状积分下降指数作为主要指标,生活质量改善程度作为次要指标。结果:试验组和治疗组相比,症状积分下降指数、生活质量改善程度、不良反应发生率均相似,即0.78±0.24,0.76±0.23;96.4%,94.6%;以及13.6%,14.3%。结论:右布地奈德鼻喷雾剂治疗过敏性鼻炎与布地奈德鼻喷雾剂同样安全有效。
Objective： To compare the efficacy and safety of R-budesonide nasal spray in the treatment of allergic rhinitis with those ofbudesonide nasal spray. Methods： A multi-center, randomized, open and parallel-controlled clinical trail was performed. Two hundred and twenty-two patients with allergic rhinitis were assigned randomly into two groups： experimental group （110 cases） and control group （112 cases）. The patients in the experimental group received R-budesonide nasal spray 50 μg （2 puffs） into each nostril twice daily and the patients in the control group received budesonide nasal spray 64 μg （1 puff） into each nostril twice daily. The duration of treatment in the two groups was 14 days. The clinical effects were evaluated according to the symptom score reducing index regarded as the main index and the improvement in quality of/ife after therapy regarded as the secondary index. Results： 0The symptom score reducing index, the improvement in quality of life, and the incidence of adverse reactions were similar among the experimental group compared with the comtrol group, that is, 0.78±0.24 vs 0.76±0.23, 96.4% vs 94.6%, and 13.6% vs 14.3%. Conclusion： R-budesonide nasal spray has the same efficacy and safety as budesonide nasal spray in the treatment of allergic rhinitis.
出处
《药物不良反应杂志》
2007年第3期162-165,共4页
Adverse Drug Reactions Journal
