布地奈德福莫特罗治疗轻度哮喘的对照试验
2019/06/13
摘要
背景：在双盲、安慰剂对照试验中，按需使用布地奈德福莫特罗比按需使用短效β2受体激动剂（SABA）更能降低哮喘严重恶化的风险；风险与布地奈德维持治疗加上按需使用SABA相似。为了更好地反映临床实践而设计的临床试验所获得的数据的是有意义的。
方法：我们对成人轻度哮喘患者进行了一项52周、随机、开放、平行、对照试验。将患者随机分为三个治疗组：沙丁胺醇（100μg，根据哮喘症状需要，从加压定 量吸入器中吸入两吸）（沙丁胺醇组）；布地奈德（200μg，每日两次，通过都保吸入）加上按需使用沙丁胺醇（布地奈德维持组）；或布地奈德福莫特罗（200μg布地奈德和6μg福莫特罗，根据需要通过都保吸入）（布地奈德福莫特罗组）。电子监控吸入器被用来测量药物的使用。主要结果是哮喘年恶化率。
结果：在675例接受随机分组的患者中，668例被纳入分析。布地奈德福莫特罗组的年加重率低于沙丁胺醇组（绝对值为0.195 vs.0.400；相对率为0.49；95%置信区间[CI]，0.33～0.72；P<0.001），与布地奈德维持组无显著差异（布地奈德福莫特罗组绝对值为0.195, vs. 布地奈德维持组0.175；相对率为1.12；95%可信区间为0.70-1.79；P=0.65）。布地奈德福莫特罗组的严重恶化次数低于沙丁胺醇组（9比23；相对危险度，0.40；95%可信区间，0.18至0.86）和布地奈德维持组（9比21；相对危险度，0.44；95%可信区间，0.20至0.96）。布地奈德福莫特罗组吸入布地奈德的平均（±SD）剂量为每天107±109μg，布地奈德维持组吸入布地奈德的平均（±SD）剂量为每天222±113μg。报告的不良事件发生率和类型与以前的试验和临床应用报告一致。
结论：在一项涉及轻度哮喘成人的开放性试验中，根据需要使用布地奈德福莫特罗优于根据需要使用沙丁胺醇预防哮喘加重。（由阿斯利康和新西兰健康研究委员会资助；新开始澳大利亚新西兰临床试验注册号，ACTRN1261500000999538）。
Beasley R, Holliday M, Reddel HK, Braithwaite I, Ebmeier S, Hancox RJ, Harrison T, Houghton C, Oldfield K, Papi A, Pavord ID, Williams M, Weatherall M; Novel START Study Team.
Abstract
BACKGROUND: In double-blind, placebo-controlled trials, budesonide-formoterol used on an as-needed basis resulted in a lower risk of severe exacerbation of asthma than as-needed use of a short-acting β2-agonist (SABA); the risk was similar to that of budesonide maintenance therapy plus as-needed SABA. The availability of data from clinical trials designed to better reflect clinical practice would be beneficial.
METHODS: We conducted a 52-week, randomized, open-label, parallel-group, controlled trial involving adults with mild asthma. Patients were randomly assigned to one of three treatment groups: albuterol (100 μg, two inhalations from a pressurized metered-dose inhaler as needed for asthma symptoms) (albuterol group); budesonide (200 μg, one inhalation through a Turbuhaler twice daily) plus as-needed albuterol (budesonide maintenance group); or budesonide-formoterol (200 μg of budesonide and 6 μg of formoterol, one inhalation through a Turbuhaler as needed) (budesonide-formoterol group). Electronic monitoring of inhalers was used to measure medication use. The primary outcome was the annualized rate of asthma exacerbations.
RESULTS: The analysis included 668 of 675 patients who underwent randomization. The annualized exacerbation rate in the budesonide-formoterol group was lower than that in the albuterol group (absolute rate, 0.195 vs. 0.400; relative rate, 0.49; 95% confidence interval [CI], 0.33 to 0.72; P<0.001) and did not differ significantly from the rate in the budesonide maintenance group (absolute rate, 0.195 in the budesonide-formoterol group vs. 0.175 in the budesonide maintenance group; relative rate, 1.12; 95% CI, 0.70 to 1.79; P = 0.65). The number of severe exacerbations was lower in the budesonide-formoterol group than in both the albuterol group (9 vs. 23; relative risk, 0.40; 95% CI, 0.18 to 0.86) and the budesonide maintenance group (9 vs. 21; relative risk, 0.44; 95% CI, 0.20 to 0.96). The mean (±SD) dose of inhaled budesonide was 107±109 μg per day in the budesonide-formoterol group and 222±113 μg per day in the budesonide maintenance group. The incidence and type of adverse events reported were consistent with those in previous trials and with reports in clinical use.
CONCLUSIONS: In an open-label trial involving adults with mild asthma, budesonide-formoterol used as needed was superior to albuterol used as needed for the prevention of asthma exacerbations. (Funded by AstraZeneca and the Health Research Council of New Zealand; Novel START Australian New Zealand Clinical Trials Registry number, ACTRN12615000999538.).
背景：在双盲、安慰剂对照试验中，按需使用布地奈德福莫特罗比按需使用短效β2受体激动剂（SABA）更能降低哮喘严重恶化的风险；风险与布地奈德维持治疗加上按需使用SABA相似。为了更好地反映临床实践而设计的临床试验所获得的数据的是有意义的。
方法：我们对成人轻度哮喘患者进行了一项52周、随机、开放、平行、对照试验。将患者随机分为三个治疗组：沙丁胺醇（100μg，根据哮喘症状需要，从加压定 量吸入器中吸入两吸）（沙丁胺醇组）；布地奈德（200μg，每日两次，通过都保吸入）加上按需使用沙丁胺醇（布地奈德维持组）；或布地奈德福莫特罗（200μg布地奈德和6μg福莫特罗，根据需要通过都保吸入）（布地奈德福莫特罗组）。电子监控吸入器被用来测量药物的使用。主要结果是哮喘年恶化率。
结果：在675例接受随机分组的患者中，668例被纳入分析。布地奈德福莫特罗组的年加重率低于沙丁胺醇组（绝对值为0.195 vs.0.400；相对率为0.49；95%置信区间[CI]，0.33～0.72；P<0.001），与布地奈德维持组无显著差异（布地奈德福莫特罗组绝对值为0.195, vs. 布地奈德维持组0.175；相对率为1.12；95%可信区间为0.70-1.79；P=0.65）。布地奈德福莫特罗组的严重恶化次数低于沙丁胺醇组（9比23；相对危险度，0.40；95%可信区间，0.18至0.86）和布地奈德维持组（9比21；相对危险度，0.44；95%可信区间，0.20至0.96）。布地奈德福莫特罗组吸入布地奈德的平均（±SD）剂量为每天107±109μg，布地奈德维持组吸入布地奈德的平均（±SD）剂量为每天222±113μg。报告的不良事件发生率和类型与以前的试验和临床应用报告一致。
结论：在一项涉及轻度哮喘成人的开放性试验中，根据需要使用布地奈德福莫特罗优于根据需要使用沙丁胺醇预防哮喘加重。（由阿斯利康和新西兰健康研究委员会资助；新开始澳大利亚新西兰临床试验注册号，ACTRN1261500000999538）。
(中日友好医院呼吸与危重症医学科 李红雯 摘译 林江涛 审校)
(N Engl J Med. 2019 May 23;380(21):2020-2030. doi: 10.1056/NEJMoa1901963.)
Controlled Trial of Budesonide-Formoterol as Needed for Mild Asthma.(N Engl J Med. 2019 May 23;380(21):2020-2030. doi: 10.1056/NEJMoa1901963.)
Beasley R, Holliday M, Reddel HK, Braithwaite I, Ebmeier S, Hancox RJ, Harrison T, Houghton C, Oldfield K, Papi A, Pavord ID, Williams M, Weatherall M; Novel START Study Team.
Abstract
BACKGROUND: In double-blind, placebo-controlled trials, budesonide-formoterol used on an as-needed basis resulted in a lower risk of severe exacerbation of asthma than as-needed use of a short-acting β2-agonist (SABA); the risk was similar to that of budesonide maintenance therapy plus as-needed SABA. The availability of data from clinical trials designed to better reflect clinical practice would be beneficial.
METHODS: We conducted a 52-week, randomized, open-label, parallel-group, controlled trial involving adults with mild asthma. Patients were randomly assigned to one of three treatment groups: albuterol (100 μg, two inhalations from a pressurized metered-dose inhaler as needed for asthma symptoms) (albuterol group); budesonide (200 μg, one inhalation through a Turbuhaler twice daily) plus as-needed albuterol (budesonide maintenance group); or budesonide-formoterol (200 μg of budesonide and 6 μg of formoterol, one inhalation through a Turbuhaler as needed) (budesonide-formoterol group). Electronic monitoring of inhalers was used to measure medication use. The primary outcome was the annualized rate of asthma exacerbations.
RESULTS: The analysis included 668 of 675 patients who underwent randomization. The annualized exacerbation rate in the budesonide-formoterol group was lower than that in the albuterol group (absolute rate, 0.195 vs. 0.400; relative rate, 0.49; 95% confidence interval [CI], 0.33 to 0.72; P<0.001) and did not differ significantly from the rate in the budesonide maintenance group (absolute rate, 0.195 in the budesonide-formoterol group vs. 0.175 in the budesonide maintenance group; relative rate, 1.12; 95% CI, 0.70 to 1.79; P = 0.65). The number of severe exacerbations was lower in the budesonide-formoterol group than in both the albuterol group (9 vs. 23; relative risk, 0.40; 95% CI, 0.18 to 0.86) and the budesonide maintenance group (9 vs. 21; relative risk, 0.44; 95% CI, 0.20 to 0.96). The mean (±SD) dose of inhaled budesonide was 107±109 μg per day in the budesonide-formoterol group and 222±113 μg per day in the budesonide maintenance group. The incidence and type of adverse events reported were consistent with those in previous trials and with reports in clinical use.
CONCLUSIONS: In an open-label trial involving adults with mild asthma, budesonide-formoterol used as needed was superior to albuterol used as needed for the prevention of asthma exacerbations. (Funded by AstraZeneca and the Health Research Council of New Zealand; Novel START Australian New Zealand Clinical Trials Registry number, ACTRN12615000999538.).
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早期呼吸道病毒感染与儿童哮喘的发展:系统回顾和荟萃分析的方案
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莫米松或噻托溴铵与痰低嗜酸性粒细胞水平轻度哮喘治疗
