布地奈德/福莫特罗维持及缓解策略勇于青少年哮喘人群
2018/01/19
摘要
青少年哮喘控制情况通常欠佳，极少研究评价这一人群的哮喘治疗。本研究通过析因分析评价布地奈德/福莫特罗（BUD/FORM）维持及缓解策略（MART）在青少年（12~17岁）持续哮喘中的疗效，总计纳入6个随机、双盲研究。首要研究终点为初次急性重度加重的时间。次要研究终点为重度急性加重的次数，哮喘相关症状，夜间症状，日间PEF，FEV1, 按需用药以及ACQ问卷。在青少年中（n=1847），BUD/FORM MART在所有研究中在降低首次重度急性加重的时间方面均等于或优于对照药物（HR BUD/FORM v.s. 对照物 0.15-1.01; 集中HR 0.49, 95%CI:0.34-0.70），这一点与成人数据相似（n=12197）。在次要研究终点观察中BUD/FORM MART同样获益。按需用药在BUD/FORM MART更少见，且青少年较成人更好。所有治疗耐受性均可。这一研究结果支持在BUD/FORM MART用于青少年持续性哮喘，其有效性和安全性与成人研究相一致。
Budesonide/formoterol maintenance and reliever therapy in adolescent patients with asthma.
Eur Respir J. 2018 Jan 4;51(1). pii: 1701688. doi: 10.1183/13993003.01688-2017. Print 2018 Jan.
Jorup C, Lythgoe D, Bisgaard H.
Abstract
Asthma control is often suboptimal in adolescents, but few studies have evaluated asthma treatments in this population. This post hoc analysis assessed the efficacy and safety of budesonide/formoterol (BUD/FORM) maintenance and reliever therapy (MART) for treatment of persistent asthma in adolescent (age 12-17 years) subgroups within six randomised, double-blind trials. The primary end-point was time to first severe exacerbation. Secondary end-points included number of severe exacerbations, asthma-related symptoms, night-time awakenings, morning peak expiratory flow, forced expiratory volume in 1 s, as-needed medication use and five-item asthma control questionnaire scores. In adolescents (n=1847), BUD/FORM MART was similar to or more effective than comparators across each of the studies in reducing the risk of a first severe exacerbation (hazard ratios (HR) BUD/FORM MART versus comparators 0.15-1.01; pooled HR 0.49, 95% CI 0.34-0.70), with comparable outcomes to the adult subgroups (n=12 197). Similar treatment benefits for BUD/FORM MART were observed for secondary end-points. As-needed medication use was lower with BUD/FORM MART than comparators, and BUD/FORM as-needed use was lower in adolescents than adults. Treatment was well tolerated. This analysis supports the use of BUD/FORM MART in adolescents with persistent asthma, its efficacy and safety being consistent with that reported for adults.
青少年哮喘控制情况通常欠佳，极少研究评价这一人群的哮喘治疗。本研究通过析因分析评价布地奈德/福莫特罗（BUD/FORM）维持及缓解策略（MART）在青少年（12~17岁）持续哮喘中的疗效，总计纳入6个随机、双盲研究。首要研究终点为初次急性重度加重的时间。次要研究终点为重度急性加重的次数，哮喘相关症状，夜间症状，日间PEF，FEV1, 按需用药以及ACQ问卷。在青少年中（n=1847），BUD/FORM MART在所有研究中在降低首次重度急性加重的时间方面均等于或优于对照药物（HR BUD/FORM v.s. 对照物 0.15-1.01; 集中HR 0.49, 95%CI:0.34-0.70），这一点与成人数据相似（n=12197）。在次要研究终点观察中BUD/FORM MART同样获益。按需用药在BUD/FORM MART更少见，且青少年较成人更好。所有治疗耐受性均可。这一研究结果支持在BUD/FORM MART用于青少年持续性哮喘，其有效性和安全性与成人研究相一致。
（上海交通大学医学院附属瑞金医院呼吸与危重症医学科 周剑平 万欢英 摘译）
（Eur Respir J. 2018 Jan 4;51(1). pii: 1701688. doi: 10.1183/13993003.01688-2017. Print 2018 Jan.）
（Eur Respir J. 2018 Jan 4;51(1). pii: 1701688. doi: 10.1183/13993003.01688-2017. Print 2018 Jan.）
Budesonide/formoterol maintenance and reliever therapy in adolescent patients with asthma.
Eur Respir J. 2018 Jan 4;51(1). pii: 1701688. doi: 10.1183/13993003.01688-2017. Print 2018 Jan.
Jorup C, Lythgoe D, Bisgaard H.
Abstract
Asthma control is often suboptimal in adolescents, but few studies have evaluated asthma treatments in this population. This post hoc analysis assessed the efficacy and safety of budesonide/formoterol (BUD/FORM) maintenance and reliever therapy (MART) for treatment of persistent asthma in adolescent (age 12-17 years) subgroups within six randomised, double-blind trials. The primary end-point was time to first severe exacerbation. Secondary end-points included number of severe exacerbations, asthma-related symptoms, night-time awakenings, morning peak expiratory flow, forced expiratory volume in 1 s, as-needed medication use and five-item asthma control questionnaire scores. In adolescents (n=1847), BUD/FORM MART was similar to or more effective than comparators across each of the studies in reducing the risk of a first severe exacerbation (hazard ratios (HR) BUD/FORM MART versus comparators 0.15-1.01; pooled HR 0.49, 95% CI 0.34-0.70), with comparable outcomes to the adult subgroups (n=12 197). Similar treatment benefits for BUD/FORM MART were observed for secondary end-points. As-needed medication use was lower with BUD/FORM MART than comparators, and BUD/FORM as-needed use was lower in adolescents than adults. Treatment was well tolerated. This analysis supports the use of BUD/FORM MART in adolescents with persistent asthma, its efficacy and safety being consistent with that reported for adults.
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