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在轻度哮喘患者中按需使用布地奈德-福莫特罗与维持使用布地奈德的研究

2018/11/02

   摘要
   背景:轻度哮喘患者通常依赖吸入短效β2受体激动剂来缓解症状, 并且对维持治疗的依从性较差。另一种方法可能是病人在必要的基础上使用快速起效的缓解剂联合吸入糖皮质激素以缓解症状和急性加重风险。
   方法:我们进行了为期52周、双盲、多中心的试验, 涉及12岁或以上患有轻度哮喘的患者, 并有资格接受定期吸入糖皮质激素治疗。患者被随机分配接受按需使用安慰剂加布地奈德-福莫特罗 (200 微克的布地奈德和6微克的福莫特罗) 每日两次,或按需使用布地奈德(200 微克) 加特普他林 (0.5 毫克)维持治疗每日两次。主要分析比较按需使用布地奈德-福莫特罗和布地奈德维持治疗的每年急性加重的发病率, 预设的非劣限值为1.2。根据哮喘控制问卷-5 (ACQ-5) 的分数评估症状, 0分为无损害,6分为损害最大。
   结果:总共4215例患者进行随机化, 共4176人 (布地奈德-福莫特罗组有2089人,布地奈德维持组有2087人) 纳入完整的分析集。在急性加重率方面,按需使用布地奈德-福莫特罗非劣于布地奈德维持疗法,急性加重率分别为 0.11 (95% 置信区间 [CI]为0.10 至 0.13) 和 0.12 (95% 置信区间为0.10 至 0.14),  率比为0.97,上单侧95% 置信限为1.16。吸入糖皮质激素的每日剂量中位数布地奈德-福莫特罗组 (66 微克) 低于布地奈德维持组 (267 微克)。第一次急性加重时间是两组是相似的(风险比率为0.96; 95% CI为0.78 到 1.17)。ACQ-5 评分的变化显示布地奈德维护治疗比按需使用布地奈德-福莫特罗有0.11个单位 (95% CI为0.07 至 0.15) 的优势差异。
   结论:在轻度哮喘患者中, 52周的治疗过程显示在重症哮喘急性加重率方面按需使用布地奈德-福莫特罗非劣于每日两次布地奈德维持治疗, 但在控制症状方面较差。布地奈德-福莫特罗组患者与布地奈德维持组相比,约有四分之一的吸入糖皮质激素暴露量。

 
(中日友好医院呼吸与危重症医学科 禹汶伯 摘译 林江涛 审校)
(N Engl J Med. 2018 May 17;378(20):1877-1887.)
 
 
 
As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma.

Bateman ED, Reddel HK, O'Byrne PM, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Siwek-Posluszna A, FitzGerald JM.

Abstract
BACKGROUND: Patients with mild asthma often rely on inhaled short-acting β2-agonists for symptom relief and have poor adherence to maintenance therapy. Another approach might be for patients to receive a fast-acting reliever plus an inhaled glucocorticoid component on an as-needed basis to address symptoms and exacerbation risk.
METHODS: We conducted a 52-week, double-blind, multicenter trial involving patients 12 years of age or older who had mild asthma and were eligible for treatment with regular inhaled glucocorticoids. Patients were randomly assigned to receive twice-daily placebo plus budesonide-formoterol (200 μg of budesonide and 6 μg of formoterol) used as needed or budesonide maintenance therapy with twice-daily budesonide (200 μg) plus terbutaline (0.5 mg) used as needed. The primary analysis compared budesonide-formoterol used as needed with budesonide maintenance therapy with regard to the annualized rate of severe exacerbations, with a prespecified noninferiority limit of 1.2. Symptoms were assessed according to scores on the Asthma Control Questionnaire-5 (ACQ-5) on a scale from 0 (no impairment) to 6 (maximum impairment).
RESULTS: A total of 4215 patients underwent randomization, and 4176 (2089 in the budesonide-formoterol group and 2087 in the budesonide maintenance group) were included in the full analysis set. Budesonide-formoterol used as needed was noninferior to budesonide maintenance therapy for severe exacerbations; the annualized rate of severe exacerbations was 0.11 (95% confidence interval [CI], 0.10 to 0.13) and 0.12 (95% CI, 0.10 to 0.14), respectively (rate ratio, 0.97; upper one-sided 95% confidence limit, 1.16). The median daily metered dose of inhaled glucocorticoid was lower in the budesonide-formoterol group (66 μg) than in the budesonide maintenance group (267 μg). The time to the first exacerbation was similar in the two groups (hazard ratio, 0.96; 95% CI, 0.78 to 1.17). The change in ACQ-5 score showed a difference of 0.11 units (95% CI, 0.07 to 0.15) in favor of budesonide maintenance therapy.
CONCLUSIONS: In patients with mild asthma, budesonide-formoterol used as needed was noninferior to twice-daily budesonide with respect to the rate of severe asthma exacerbations during 52 weeks of treatment but was inferior in controlling symptoms. Patients in the budesonide-formoterol group had approximately one quarter of the inhaled glucocorticoid exposure of those in the budesonide maintenance group.





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