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布地奈德鼻喷雾剂与口服阿司咪唑治疗常年性鼻炎的双盲对照研究

A double-blind comparison of nasal budesonide and oral astemizole for the treatment of perennial rhinitis.

作者信息

Bunnag C, Jareoncharsri P, Wong E C

机构信息

Department of Otolaryngology, Siriraj Hospital, Bangkok, Thailand.

出版信息

Allergy. 1992 Aug;47(4 Pt 1):313-7. doi: 10.1111/j.1398-9995.1992.tb02060.x.

Abstract

Sixty-nine outpatients with symptomatic perennial rhinitis were recruited to this double-blind, parallel-group study to compare budesonide nasal spray with oral astemizole. Following a 1-week run-in on placebo, 67 patients achieved a mean daily total symptom score of at least 4 (scoring for each symptom was 0 = none, 1 = mild, 2 = moderate, 3 = severe), and were randomized to study treatments - 33 to budesonide, 100 micrograms in each nostril morning and evening, and 34 to astemizole, one 10-mg tablet each morning, for a period of 4 weeks. No antihistamine preparations other than eye drops and no corticosteroids were permitted during the active treatment period. Patients recorded symptoms of blocked nose, runny nose, sneezing, itchy nose, sore eyes or runny eyes in diary cards each evening before retiring. Diary card data showed that there was significantly greater improvement in blocked nose, runny nose and runny eyes during the first 2 weeks of budesonide treatment than during the same period on astemizole. A similar, although non-significant, trend was observed for sneezing and itchy nose, but there was no apparent difference in the reporting of sore eyes. After 4 weeks, blocked nose and runny nose remained significantly less troublesome in the budesonide group. Both treatments were well-tolerated and no major adverse effects were reported. Patient ratings for treatment efficacy were significantly higher for budesonide than astemizole at both 2 weeks and 4 weeks.

摘要

69例有症状的常年性鼻炎门诊患者被纳入这项双盲、平行组研究,以比较布地奈德鼻喷雾剂和口服阿司咪唑。在使用安慰剂进行1周导入期后,67例患者的每日总症状评分均值至少达到4分(每种症状的评分标准为:0=无,1=轻度,2=中度,3=重度),并被随机分配接受研究治疗——33例接受布地奈德治疗,早晚各每个鼻孔喷入100微克;34例接受阿司咪唑治疗,每天早晨服用1片10毫克片剂,为期4周。在积极治疗期间,除眼药水外不允许使用其他抗组胺制剂,也不允许使用皮质类固醇。患者每天晚上睡前在日记卡上记录鼻塞、流涕、打喷嚏、鼻痒、眼痛或流泪等症状。日记卡数据显示,布地奈德治疗的前2周,鼻塞、流涕和流泪症状的改善程度明显大于阿司咪唑治疗的同期。打喷嚏和鼻痒也观察到类似趋势,尽管不显著,但眼痛报告方面没有明显差异。4周后,布地奈德组的鼻塞和流涕症状仍然明显减轻。两种治疗耐受性良好,未报告重大不良反应。在2周和4周时,患者对布地奈德治疗效果的评分均显著高于阿司咪唑。

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