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布地奈德或西替利嗪对常年性鼻炎的早期治疗及其对长期疗效的影响。

Early treatment of perennial rhinitis with budesonide or cetirizine and its effect on long-term outcome.

作者信息

Rinne Juhani, Simola Markku, Malmberg Henrik, Haahtela Tari

机构信息

Division of Allergy, Skin and Allergy Hospital, University of Helsinki, Finland.

出版信息

J Allergy Clin Immunol. 2002 Mar;109(3):426-32. doi: 10.1067/mai.2002.121703.

DOI:10.1067/mai.2002.121703
PMID:11897986
Abstract

BACKGROUND

Perennial rhinitis is a common disease that has many similarities with bronchial asthma. Early treatment with inhaled steroids has improved asthma symptoms, lung function, and bronchial hyperreactivity, but it has not been studied in perennial rhinitis.

OBJECTIVE

The main objective was to determine whether early introduction of long-term daily intranasal steroid treatment would have a positive effect on the clinical course and outcome of perennial rhinitis compared with the effect of an antihistamine. A secondary objective was to compare the clinical efficacy of intranasal budesonide and oral cetirizine.

METHODS

One hundred forty-three adult patients with newly detected perennial allergic or nonallergic eosinophilic rhinitis of 1 to 3 years' duration were randomized to receive budesonide dry powder, 400 microg (delivered dose of 280 microg) intranasally, or cetirizine, 10 mg orally, once daily for 1 year. At the end of the double-blind treatment period, medication was stopped, and the patients were followed for another year, during which time they could use 14-day courses of intranasal budesonide as needed to control rhinitis relapses. The main outcome measures were the time to first relapse and the number of relapses during the second year. Nasal symptom scores, nasal smear eosinophilia, and nasal peak expiratory flow were used to compare the clinical efficacy of the 2 treatments.

RESULTS

During the randomized phase of the study, budesonide was significantly more effective than cetirizine in relieving nasal symptoms. Nasal peak expiratory flow improved significantly in budesonide-treated patients compared with in patients receiving cetirizine. After discontinuation of randomized treatment, 38% of budesonide-treated and 56% of cetirizine-treated patients had a relapse within the first month (P =.04). The median time to first relapse was longer in budesonide-treated patients than in cetirizine-treated patients (62 vs 20 days), although the difference was not significant. Fourteen-day courses of budesonide provided effective control of relapses; the mean number of relapses was 4.0 versus 5.4 in the groups previously treated with budesonide or cetirizine, respectively. Both treatments were well tolerated throughout the study.

CONCLUSIONS

Budesonide is significantly more effective than cetirizine in controlling perennial rhinitis. After stopping treatment, budesonide better prevents relapses for 1 to 2 months compared with cetirizine. Periodic therapy with budesonide may be sufficient to control symptoms in most patients who have relapses.

摘要

背景

常年性鼻炎是一种常见疾病,与支气管哮喘有许多相似之处。吸入性类固醇的早期治疗改善了哮喘症状、肺功能和支气管高反应性,但尚未在常年性鼻炎中进行研究。

目的

主要目的是确定与抗组胺药相比,早期长期每日鼻内使用类固醇治疗对常年性鼻炎的临床病程和结局是否有积极影响。次要目的是比较鼻内布地奈德和口服西替利嗪的临床疗效。

方法

143例新诊断的病程为1至3年的成年常年性变应性或非变应性嗜酸性粒细胞性鼻炎患者被随机分为两组,分别接受鼻内给予布地奈德干粉400μg(递送剂量280μg)或口服西替利嗪10mg,每日1次,共1年。在双盲治疗期结束时,停止用药,对患者随访1年,在此期间他们可根据需要使用14天疗程的鼻内布地奈德来控制鼻炎复发。主要结局指标为首次复发时间和第2年的复发次数。采用鼻症状评分、鼻涂片嗜酸性粒细胞计数和鼻呼气峰流速来比较两种治疗方法的临床疗效。

结果

在研究的随机阶段,布地奈德在缓解鼻症状方面明显比西替利嗪更有效。与接受西替利嗪治疗的患者相比,布地奈德治疗的患者鼻呼气峰流速显著改善。随机治疗停止后,38%接受布地奈德治疗的患者和56%接受西替利嗪治疗的患者在第一个月内复发(P = 0.04)。布地奈德治疗的患者首次复发的中位时间比西替利嗪治疗的患者长(62天对20天),尽管差异不显著。14天疗程的布地奈德能有效控制复发;之前接受布地奈德或西替利嗪治疗的组中,复发的平均次数分别为4.0次和5.4次。在整个研究过程中,两种治疗的耐受性都良好。

结论

布地奈德在控制常年性鼻炎方面明显比西替利嗪更有效。停止治疗后,与西替利嗪相比,布地奈德在1至2个月内能更好地预防复发。对于大多数复发的患者,布地奈德的定期治疗可能足以控制症状。

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