对于轻度哮喘患者按需联合吸入布地奈德-福莫特罗的研究
2018/07/09
摘要
背景：在轻度哮喘患者中, 按需使用吸入糖皮质激素加上短效β2受体激动剂可能替代传统治疗策略。
方法：我们对12岁或以上的轻度哮喘患者进行了为期52周的双盲试验。将患者随机分配到三种方案之一: 每日两次使用安慰剂加按需使用特布他林 (0.5 毫克) (特布他林组), 每日两次使用安慰剂加按需使用布地奈德-福莫特罗 (200 微克的布地奈德和6微克的福莫特罗) (布地奈德-福莫特罗组), 或每日两次使用布地奈德 (200 微克) 加上按需使用特布他林(布地奈德维持组)。主要目的是研究在电子记录周内按需使用布地奈德-福莫特罗与按需使用特布他林对于得到哮喘良好控制的优越性。
结果：总共对3849例患者进行随机化分组，,对3836 例患者（特布他林组1277例，布地奈德-福莫特罗组1277例, 布地奈德维持组 1282例）进行安全数据集全面分析。从每位患者哮喘得到良好控制的平均周数来看, 布地奈德-福莫特罗组优于特布他林组 (34.4% 与31.1% 周;OR值为1.14; 95% 置信区间 [CI]为1.00至1.30;P = 0.046) ，但劣于布地奈德维持组(分别为34.4% 和 44.4%; OR值为0.64; 95% CI为0.57至0.73)。每年急性加重率为特布他林组为0.20, 布地奈德-福莫特罗组为0.07, 布地奈德维持组为0.09;布地奈德-福莫特罗组对特布他林组的OR值为0.36 (95% CI为0.27至0.49)，布地奈德-福莫特罗组与布地奈德维持组的OR值为0.83(95% CI为0.59至1.16)。布地奈德维持组的坚持率为78.9%。从每日吸入糖皮质激素剂量的中位数来看，布地奈德-福莫特罗组 (57 微克)是布地奈德维持组 (340 微克) 的17%。
结论：根据电子记录周内哮喘得到良好控制的情况对轻度哮喘患者的哮喘-症状控制进行评估， 按需使用布地奈德-福莫特罗优于按需使用特布他林,但劣于布地奈德维持治疗。两种含布地奈德的治疗方案的急性加重率相似,且低于按需使用特布他林。与布地奈德维持治疗相比，按需使用布地奈德-福莫特罗可显著降低糖皮质激素暴露率。
Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma.
O'Byrne PM, FitzGerald JM, Bateman ED, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Ivanov S, Reddel HK.
Abstract
BACKGROUND: In patients with mild asthma, as-needed use of an inhaled glucocorticoid plus a fast-acting β2-agonist may be an alternative to conventional treatment strategies.
METHODS: We conducted a 52-week, double-blind trial involving patients 12 years of age or older with mild asthma. Patients were randomly assigned to one of three regimens: twice-daily placebo plus terbutaline (0.5 mg) used as needed (terbutaline group), twice-daily placebo plus budesonide-formoterol (200 μg of budesonide and 6 μg of formoterol) used as needed (budesonide-formoterol group), or twice-daily budesonide (200 μg) plus terbutaline used as needed (budesonide maintenance group). The primary objective was to investigate the superiority of as-needed budesonide-formoterol to as-needed terbutaline with regard to electronically recorded weeks with well-controlled asthma.
RESULTS: A total of 3849 patients underwent randomization, and 3836 (1277 in the terbutaline group, 1277 in the budesonide-formoterol group, and 1282 in the budesonide maintenance group) were included in the full analysis and safety data sets. With respect to the mean percentage of weeks with well-controlled asthma per patient, budesonide-formoterol was superior to terbutaline (34.4% vs. 31.1% of weeks; odds ratio, 1.14; 95% confidence interval [CI], 1.00 to 1.30; P=0.046) but inferior to budesonide maintenance therapy (34.4% and 44.4%, respectively; odds ratio, 0.64; 95% CI, 0.57 to 0.73). The annual rate of severe exacerbations was 0.20 with terbutaline, 0.07 with budesonide-formoterol, and 0.09 with budesonide maintenance therapy; the rate ratio was 0.36 (95% CI, 0.27 to 0.49) for budesonide-formoterol versus terbutaline and 0.83 (95% CI, 0.59 to 1.16) for budesonide-formoterol versus budesonide maintenance therapy. The rate of adherence in the budesonide maintenance group was 78.9%. The median metered daily dose of inhaled glucocorticoid in the budesonide-formoterol group (57 μg) was 17% of the dose in the budesonide maintenance group (340 μg).
CONCLUSIONS: In patients with mild asthma, as-needed budesonide-formoterol provided superior asthma-symptom control to as-needed terbutaline, assessed according to electronically recorded weeks with well-controlled asthma, but was inferior to budesonide maintenance therapy. Exacerbation rates with the two budesonide-containing regimens were similar and were lower than the rate with terbutaline. Budesonide-formoterol used as needed resulted in substantially lower glucocorticoid exposure than budesonide maintenance therapy.
背景：在轻度哮喘患者中, 按需使用吸入糖皮质激素加上短效β2受体激动剂可能替代传统治疗策略。
方法：我们对12岁或以上的轻度哮喘患者进行了为期52周的双盲试验。将患者随机分配到三种方案之一: 每日两次使用安慰剂加按需使用特布他林 (0.5 毫克) (特布他林组), 每日两次使用安慰剂加按需使用布地奈德-福莫特罗 (200 微克的布地奈德和6微克的福莫特罗) (布地奈德-福莫特罗组), 或每日两次使用布地奈德 (200 微克) 加上按需使用特布他林(布地奈德维持组)。主要目的是研究在电子记录周内按需使用布地奈德-福莫特罗与按需使用特布他林对于得到哮喘良好控制的优越性。
结果：总共对3849例患者进行随机化分组，,对3836 例患者（特布他林组1277例，布地奈德-福莫特罗组1277例, 布地奈德维持组 1282例）进行安全数据集全面分析。从每位患者哮喘得到良好控制的平均周数来看, 布地奈德-福莫特罗组优于特布他林组 (34.4% 与31.1% 周;OR值为1.14; 95% 置信区间 [CI]为1.00至1.30;P = 0.046) ，但劣于布地奈德维持组(分别为34.4% 和 44.4%; OR值为0.64; 95% CI为0.57至0.73)。每年急性加重率为特布他林组为0.20, 布地奈德-福莫特罗组为0.07, 布地奈德维持组为0.09;布地奈德-福莫特罗组对特布他林组的OR值为0.36 (95% CI为0.27至0.49)，布地奈德-福莫特罗组与布地奈德维持组的OR值为0.83(95% CI为0.59至1.16)。布地奈德维持组的坚持率为78.9%。从每日吸入糖皮质激素剂量的中位数来看，布地奈德-福莫特罗组 (57 微克)是布地奈德维持组 (340 微克) 的17%。
结论：根据电子记录周内哮喘得到良好控制的情况对轻度哮喘患者的哮喘-症状控制进行评估， 按需使用布地奈德-福莫特罗优于按需使用特布他林,但劣于布地奈德维持治疗。两种含布地奈德的治疗方案的急性加重率相似,且低于按需使用特布他林。与布地奈德维持治疗相比，按需使用布地奈德-福莫特罗可显著降低糖皮质激素暴露率。
(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):1865-1876.)
(N Engl J Med. 2018 May 17;378(20):1865-1876.)
Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma.
O'Byrne PM, FitzGerald JM, Bateman ED, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Ivanov S, Reddel HK.
Abstract
BACKGROUND: In patients with mild asthma, as-needed use of an inhaled glucocorticoid plus a fast-acting β2-agonist may be an alternative to conventional treatment strategies.
METHODS: We conducted a 52-week, double-blind trial involving patients 12 years of age or older with mild asthma. Patients were randomly assigned to one of three regimens: twice-daily placebo plus terbutaline (0.5 mg) used as needed (terbutaline group), twice-daily placebo plus budesonide-formoterol (200 μg of budesonide and 6 μg of formoterol) used as needed (budesonide-formoterol group), or twice-daily budesonide (200 μg) plus terbutaline used as needed (budesonide maintenance group). The primary objective was to investigate the superiority of as-needed budesonide-formoterol to as-needed terbutaline with regard to electronically recorded weeks with well-controlled asthma.
RESULTS: A total of 3849 patients underwent randomization, and 3836 (1277 in the terbutaline group, 1277 in the budesonide-formoterol group, and 1282 in the budesonide maintenance group) were included in the full analysis and safety data sets. With respect to the mean percentage of weeks with well-controlled asthma per patient, budesonide-formoterol was superior to terbutaline (34.4% vs. 31.1% of weeks; odds ratio, 1.14; 95% confidence interval [CI], 1.00 to 1.30; P=0.046) but inferior to budesonide maintenance therapy (34.4% and 44.4%, respectively; odds ratio, 0.64; 95% CI, 0.57 to 0.73). The annual rate of severe exacerbations was 0.20 with terbutaline, 0.07 with budesonide-formoterol, and 0.09 with budesonide maintenance therapy; the rate ratio was 0.36 (95% CI, 0.27 to 0.49) for budesonide-formoterol versus terbutaline and 0.83 (95% CI, 0.59 to 1.16) for budesonide-formoterol versus budesonide maintenance therapy. The rate of adherence in the budesonide maintenance group was 78.9%. The median metered daily dose of inhaled glucocorticoid in the budesonide-formoterol group (57 μg) was 17% of the dose in the budesonide maintenance group (340 μg).
CONCLUSIONS: In patients with mild asthma, as-needed budesonide-formoterol provided superior asthma-symptom control to as-needed terbutaline, assessed according to electronically recorded weeks with well-controlled asthma, but was inferior to budesonide maintenance therapy. Exacerbation rates with the two budesonide-containing regimens were similar and were lower than the rate with terbutaline. Budesonide-formoterol used as needed resulted in substantially lower glucocorticoid exposure than budesonide maintenance therapy.
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轻度哮喘患者按需吸入布地奈德 -福莫特罗VS布地奈德维持治疗的比较
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25-羟维生素D和儿童早期哮喘的卫生服务利用
