Juniper E F, Guyatt G H, Andersson B, Ferrie P J
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Ann Allergy. 1993 Mar;70(3):225-30.
The aims of the study were to compare the efficacy and side effects of intranasal budesonide as a dry powder and as a freon propelled pressurized aerosol in the treatment of perennial rhinitis and to validate a perennial rhinitis quality of life questionnaire. The design was a single-blind, randomized, parallel group comparison of two active treatments over a 6-week period. Sixty adults with symptomatic perennial rhinitis, stratified for atopy, received 400 micrograms intranasal budesonide administered daily either as one inhalation/nostril/day of pure drug powder or two puffs/nostril/day of drug delivered by a freon propelled aerosol. Subjects kept daily symptom diaries and, at each clinic visit, rhinitis quality of life and adverse experiences were recorded. Fifty-eight subjects completed the study. During the 6 weeks, there were significant improvements in symptoms and quality of life in both treatment groups. The improvements tended to be slightly greater in the aerosol group but the differences did not reach significance. Most frequently reported adverse experiences were headache and nosebleed, which were equally distributed in the two groups. We conclude that budesonide taken 400 micrograms daily for 6 weeks was associated with improvements in perennial rhinitis with little evidence of any difference in efficacy or side effects between the powder and aerosol. The questionnaire is a valid instrument for assessing quality of life in perennial rhinitis clinical trials.
本研究的目的是比较鼻用布地奈德干粉剂和氟利昂推进式加压气雾剂治疗常年性鼻炎的疗效和副作用,并验证一份常年性鼻炎生活质量问卷。研究设计为在6周时间内对两种有效治疗方法进行单盲、随机、平行组比较。60名有症状的常年性鼻炎成年患者,根据特应性进行分层,每天接受400微克鼻用布地奈德治疗,要么是每天每个鼻孔吸入一次纯药粉,要么是每天每个鼻孔喷两次由氟利昂推进气雾剂递送的药物。受试者每天记录症状日记,每次门诊就诊时记录鼻炎生活质量和不良经历。58名受试者完成了研究。在6周内,两个治疗组的症状和生活质量均有显著改善。气雾剂组的改善趋势略大,但差异无统计学意义。最常报告的不良经历是头痛和鼻出血,两组分布相同。我们得出结论,每天服用400微克布地奈德6周可改善常年性鼻炎,几乎没有证据表明粉剂和气雾剂在疗效或副作用上有任何差异。该问卷是评估常年性鼻炎临床试验中生活质量的有效工具。