按需使用布地奈德福莫特罗治疗青少年轻度哮喘的有效性和安全性
2021/05/26
摘要
背景：青少年的药物依从性具有挑战性。对于轻度哮喘，与按需使用短效β 2-激动剂（SABA）相比，按需使用布地奈德福莫特罗（BUD-FORM）可减少严重恶化，这与维持使用布地奈德的减少类似。
目的：对SYGMA 1和SYGMA 2进行回顾性分析，评估青少年按需使用BUD-FORM的有效性和安全性。
方法：SYGMA 1和2是≥12岁的轻度哮喘患者为期52周的的双盲研究（NCT022149199；NCT02224157）。患者随机分为2次/日安慰剂+按需BUD-FORM 200/6μg, 2次/日BUD 200μg +按需特布他林（BUD维持），或2次/日安慰剂+按需特布他林0.5mg（仅SYGMA 1）。比较了青少年（≥12- 18岁）治疗组之间的年严重急性发作率、维持治疗依从性和安全性（包括身高变化）。
结果：按需使用BUD-FORM和BUD维持治疗的严重急性发作率相似（汇总分析：0.08 vs 0.07/年，p=0.634），而按需BUD-FORM的严重急性发作率显著低于按需特布他林 （SYGMA 1: 0.04 vs 0.17/年，p=0.005）。SYGMA 1组的中位依从性为73%，SYGMA 2组为51%。≥12-<14岁的青少年，按需BUD-FORM（4.8cm）的身高变化显著大于BUD维持治疗（3.9cm）（汇总：p=0.046），而按需BUD- form （4.5cm）和按需特布他林（4.1cm）的身高变化相似（SYGMA 1：p=0.500）。没有发现新的或意外的安全问题。
结论：对于青少年轻度哮喘患者，按需BUD-FORM在减少严重急性发作方面优于按需特布他林，与维持BUD的疗效相似。根据需要，BUD-FORM为患有轻度哮喘的青少年提供了一种替代治疗选择，无需每日治疗。
Efficacy and safety of as-needed budesonide-formoterol in adolescents with mild asthma
Helen K Reddel , Paul M O'Byrne, J Mark FitzGerald, Peter J Barnes, Jinping Zheng, Stefan Ivanov, Rosa Lamarca, Margareta Puu, Vijay K T Alagappan, Eric D Bateman
Abstract
Background: Medication adherence is challenging for adolescents. In mild asthma, as-needed budesonide-formoterol (BUD-FORM) reduces severe exacerbations compared with as-needed short-acting beta2-agonists (SABA), similar to the reduction with maintenance budesonide.
Objective: This post hoc pooled analysis of SYGMA 1 and 2 assessed the efficacy and safety of as-needed BUD-FORM in adolescents.
Methods: SYGMA 1 and 2 were 52-week, double-blind studies (NCT022149199; NCT02224157) in patients ≥12 years with mild asthma. Patients were randomized to twice-daily placebo + as-needed BUD-FORM 200/6μg, twice-daily BUD 200μg + as-needed terbutaline (BUD maintenance), or twice-daily placebo + as-needed terbutaline 0.5mg (SYGMA 1 only). Annualized severe exacerbation rates, maintenance treatment adherence and safety (including change in height) were compared between treatment groups in adolescents (aged ≥12-<18 years).
Results: Severe exacerbation rate was similar with as-needed BUD-FORM and BUD maintenance (pooled analysis: 0.08 vs 0.07/year, p=0.634), and was significantly lower with as-needed BUD-FORM versus as-needed terbutaline (SYGMA 1: 0.04 vs 0.17/year, p=0.005). Median adherence was 73% in SYGMA 1 and 51% in SYGMA 2. Change in height from baseline in adolescents aged ≥12-<14 years was significantly greater with as-needed BUD-FORM (4.8cm) versus BUD maintenance (3.9cm) (pooled: p<0.046), and was similar between as-needed BUD-FORM (4.5cm) and as-needed terbutaline (4.1cm) (SYGMA 1: p=0.500). No new or unexpected safety concerns were identified.
Conclusions: In adolescents with mild asthma, as-needed BUD-FORM was superior to as-needed terbutaline for severe exacerbation reduction, with similar efficacy to BUD maintenance. As-needed BUD-FORM provides an alternative treatment option for adolescents with mild asthma, without needing daily treatment.
背景：青少年的药物依从性具有挑战性。对于轻度哮喘，与按需使用短效β 2-激动剂（SABA）相比，按需使用布地奈德福莫特罗（BUD-FORM）可减少严重恶化，这与维持使用布地奈德的减少类似。
目的：对SYGMA 1和SYGMA 2进行回顾性分析，评估青少年按需使用BUD-FORM的有效性和安全性。
方法：SYGMA 1和2是≥12岁的轻度哮喘患者为期52周的的双盲研究（NCT022149199；NCT02224157）。患者随机分为2次/日安慰剂+按需BUD-FORM 200/6μg, 2次/日BUD 200μg +按需特布他林（BUD维持），或2次/日安慰剂+按需特布他林0.5mg（仅SYGMA 1）。比较了青少年（≥12- 18岁）治疗组之间的年严重急性发作率、维持治疗依从性和安全性（包括身高变化）。
结果：按需使用BUD-FORM和BUD维持治疗的严重急性发作率相似（汇总分析：0.08 vs 0.07/年，p=0.634），而按需BUD-FORM的严重急性发作率显著低于按需特布他林 （SYGMA 1: 0.04 vs 0.17/年，p=0.005）。SYGMA 1组的中位依从性为73%，SYGMA 2组为51%。≥12-<14岁的青少年，按需BUD-FORM（4.8cm）的身高变化显著大于BUD维持治疗（3.9cm）（汇总：p=0.046），而按需BUD- form （4.5cm）和按需特布他林（4.1cm）的身高变化相似（SYGMA 1：p=0.500）。没有发现新的或意外的安全问题。
结论：对于青少年轻度哮喘患者，按需BUD-FORM在减少严重急性发作方面优于按需特布他林，与维持BUD的疗效相似。根据需要，BUD-FORM为患有轻度哮喘的青少年提供了一种替代治疗选择，无需每日治疗。
(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)
(J Allergy Clin Immunol Pract. 2021 Apr 22;S2213-2198(21)00456-6. doi: 10.1016/j.jaip.2021.04.016.)
(J Allergy Clin Immunol Pract. 2021 Apr 22;S2213-2198(21)00456-6. doi: 10.1016/j.jaip.2021.04.016.)
Efficacy and safety of as-needed budesonide-formoterol in adolescents with mild asthma
Helen K Reddel , Paul M O'Byrne, J Mark FitzGerald, Peter J Barnes, Jinping Zheng, Stefan Ivanov, Rosa Lamarca, Margareta Puu, Vijay K T Alagappan, Eric D Bateman
Abstract
Background: Medication adherence is challenging for adolescents. In mild asthma, as-needed budesonide-formoterol (BUD-FORM) reduces severe exacerbations compared with as-needed short-acting beta2-agonists (SABA), similar to the reduction with maintenance budesonide.
Objective: This post hoc pooled analysis of SYGMA 1 and 2 assessed the efficacy and safety of as-needed BUD-FORM in adolescents.
Methods: SYGMA 1 and 2 were 52-week, double-blind studies (NCT022149199; NCT02224157) in patients ≥12 years with mild asthma. Patients were randomized to twice-daily placebo + as-needed BUD-FORM 200/6μg, twice-daily BUD 200μg + as-needed terbutaline (BUD maintenance), or twice-daily placebo + as-needed terbutaline 0.5mg (SYGMA 1 only). Annualized severe exacerbation rates, maintenance treatment adherence and safety (including change in height) were compared between treatment groups in adolescents (aged ≥12-<18 years).
Results: Severe exacerbation rate was similar with as-needed BUD-FORM and BUD maintenance (pooled analysis: 0.08 vs 0.07/year, p=0.634), and was significantly lower with as-needed BUD-FORM versus as-needed terbutaline (SYGMA 1: 0.04 vs 0.17/year, p=0.005). Median adherence was 73% in SYGMA 1 and 51% in SYGMA 2. Change in height from baseline in adolescents aged ≥12-<14 years was significantly greater with as-needed BUD-FORM (4.8cm) versus BUD maintenance (3.9cm) (pooled: p<0.046), and was similar between as-needed BUD-FORM (4.5cm) and as-needed terbutaline (4.1cm) (SYGMA 1: p=0.500). No new or unexpected safety concerns were identified.
Conclusions: In adolescents with mild asthma, as-needed BUD-FORM was superior to as-needed terbutaline for severe exacerbation reduction, with similar efficacy to BUD maintenance. As-needed BUD-FORM provides an alternative treatment option for adolescents with mild asthma, without needing daily treatment.
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在哮喘急性发作期间，外周血中Th2细胞标志物增多
