Day J H, Andersson C B, Briscoe M P
Division of Allergy and Immunology, Kingston General Hospital, Ontario, Canada.
Ann Allergy. 1990 May;64(5):445-50.
The efficacy and safety of intranasal budesonide were evaluated in a placebo-controlled double-blind study of 51 children (6 to 18 years) and 48 adults with perennial (allergic or nonallergic) rhinitis. The trial commenced with a 2-week baseline period without treatment for perennial rhinitis. This was followed by a treatment period of 4 weeks. Treatment was either intranasal budesonide 200 micrograms bid or matching placebo bid. Nasal symptoms were rated daily on a scale from 0 (absent) to 3 (severe). Safety was monitored by laboratory assessments (hematology, blood chemistry, urinalysis) as well as by rhinoscopy and recording of adverse events. Budesonide reduced the nasal symptoms as compared with baseline. The reduction was greater than in the placebo group and symptoms were improved significantly on budesonide treatment compared with placebo. Laboratory assessments demonstrated no differences between budesonide and placebo. Adverse responses to intranasal budesonide were few and minor, and compliance was high. Intranasal budesonide, 200 micrograms bid, thus appears to be efficacious, highly acceptable, and safe for the treatment of perennial rhinitis.
在一项针对51名儿童（6至18岁）和48名患有常年性（过敏性或非过敏性）鼻炎的成年人的安慰剂对照双盲研究中，对鼻用布地奈德的疗效和安全性进行了评估。试验开始时，有一个为期2周的基线期，在此期间不对常年性鼻炎进行治疗。随后是一个为期4周的治疗期。治疗方法为每日两次鼻用200微克布地奈德或匹配的安慰剂。每天根据0（无）至3（严重）的量表对鼻部症状进行评分。通过实验室评估（血液学、血液化学、尿液分析）以及鼻镜检查和不良事件记录来监测安全性。与基线相比，布地奈德减轻了鼻部症状。这种减轻比安慰剂组更大，并且与安慰剂相比，布地奈德治疗使症状有显著改善。实验室评估显示布地奈德和安慰剂之间没有差异。鼻用布地奈德的不良反应很少且轻微，依从性很高。因此，每日两次鼻用200微克布地奈德似乎对常年性鼻炎的治疗有效、高度可接受且安全。
