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The clinical efficacy of budesonide in hay fever treatment is dependent on topical nasal application

机译:布地奈德在花粉症治疗中的临床疗效取决于局部鼻腔应用

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SummaryDuring the last decade topical glucocorticoids have been established as the first hand choice for the treatment of allergic rhinitis. Although they are clinically effective, their precise mode of action has not been sufficiently clarified. In order to evaluate whether the clinical effect is dependent on the topical administration a randomized, double‐blind, double‐dummy study was performed. Ninety‐eight patients with allergic rhinitis due to birch pollen were recruited at two centres in southern Sweden. The patients received one of the following three treatment alternatives: 200 μg of nasally applied budesonide twice daily, 250 μg of budesonide given orally twice daily or a placebo. The selection of the doses was based on previous pharmacokinetic studies giving almost equal plasma levels of the nasally and orally administered budesonide. To evaluate the possible clinical efficacy of the treatment, the patients kept a diary in order to register symptoms according to a 0–4 scale. After a run‐in week with no treatment the patients entered the treatment period which lasted for 3 weeks. A total of 96 patients completed the study. The symptom data showed that topically applied budesonide was clinically effective with a pronounced reduction in all the nasal symptoms registered and compared with placebo treatment there was a statistically significant difference in favour of the budesonide treatment (P<0.001). The nasal symptoms of the patients receiving oral budesonide did not differ from those receiving placebo. Intranasally administered budesonide proved to be significantly more effective than orally applied budesonide (P<0.01). Thus, this study clearly demonstrates that the clinical effect of budesonide in recommended doses for hay fever treatment is dependent on the nasal
机译:摘要在过去十年中,外用糖皮质激素已被确定为治疗过敏性鼻炎的首选药物。尽管它们在临床上有效,但它们的确切作用方式尚未得到充分阐明。为了评估临床效果是否取决于局部给药,进行了一项随机、双盲、双虚拟研究。在瑞典南部的两个中心招募了98名由桦树花粉引起的过敏性鼻炎患者。患者接受了以下三种治疗方案之一:200 μg 鼻用布地奈德,每日两次,250 μg 布地奈德口服,每日两次或安慰剂。剂量的选择基于先前的药代动力学研究,鼻腔和口服布地奈德的血浆水平几乎相等。为了评估治疗的可能临床疗效,患者记录了日记,以便根据 0-4 的等级记录症状。经过一周没有治疗的磨合期后,患者进入了持续 3 周的治疗期。共有 96 名患者完成了这项研究。症状数据显示,局部应用布地奈德具有临床效果,所有鼻部症状均明显减轻,与安慰剂治疗相比,布地奈德治疗在统计学上存在显着差异(P<0.001)。接受口服布地奈德的患者的鼻部症状与接受安慰剂的患者没有差异。经证实,鼻内布地奈德比口服布地奈德更有效(P<0.01)。因此,这项研究清楚地表明,布地奈德在花粉症治疗的推荐剂量下的临床效果取决于鼻腔

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