应用四倍剂量的吸入性糖皮质激素预防哮喘急性发作
2018/06/04
摘要
研究背景：哮喘急性加重严重威胁患者健康甚至生命。我们认为哮喘患者的自我管理计划（即在哮喘控制不佳早期应用4倍剂量吸入性糖皮质激素（ICS））可以减少成年人和青少年中严重哮喘急性加重的发生率，并对这一概念进行了验证。
方法：我们开展了一项真实世界，非盲，随机的试验，纳入正在接受ICS治疗，有或没有其他辅助治疗，并且在过去一年中至少有一次急性加重的成人和青少年哮喘患者。我们对进行自我管理计划的患者观察了12个月，并比较了4倍剂量ICS组（4倍组）与不增加ICS剂量组（非4倍组）的结果。主要研究终点是距首次发生严重哮喘急性加重的时间（即系统性应用糖皮质激素治疗或进行非计划性卫生保健咨询）。
结果：实验纳入1922名患者，随机分组，最终纳入分析了1871名患者数据。4倍ICS治疗组一年内发生严重哮喘急性加重的人数为420（45％），而非4倍组为484（52％），距首次发生重度急性加重时间的调整后风险比为0.81（95％CI[0.71-0.92], P = 0.002）。与ICS局部效应相关的不良反应发生率在4倍ICS治疗组高于非4倍组。
结论：在这项包括成人和青少年哮喘患者的试验中，实施个体化自我管理计划，即在哮喘控制不佳的早期开始，临时吸入4倍剂量的ICS治疗的患者比不增加ICS的患者其严重的哮喘急性加重的发生率有所降低。
Quadrupling Inhaled Glucocorticoid Dose to Abort Asthma Exacerbations.
Abstract
BACKGROUND:Asthma exacerbations are frightening for patients and are occasionally fatal. We tested the concept that a plan for patients to manage their asthma (self-management plan), which included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate, would reduce the incidence of severe asthma exacerbations among adults and adolescents with asthma.
METHODS: We conducted a pragmatic, unblinded, randomized trial involving adults and adolescents with asthma who were receiving inhaled glucocorticoids, with or without add-on therapy, and who had had at least one exacerbation in the previous 12 months. We compared a self-management plan that included an increase in the dose of inhaled glucocorticoids by a factor of 4 (quadrupling group) with the same plan without such an increase (non-quadrupling group), over a period of 12 months. The primary outcome was the time to a first severe asthma exacerbation, defined as treatment with systemic glucocorticoids or an unscheduled health care consultation for asthma.
RESULTS:A total of 1922 participants underwent randomization, of whom 1871 were included in the primary analysis. The number of participants who had a severe asthma exacerbation in the year after randomization was 420 (45%) in the quadrupling group as compared with 484 (52%) in the non-quadrupling group, with an adjusted hazard ratio for the time to a first severe exacerbation of 0.81 (95% confidence interval, 0.71 to 0.92; P=0.002). The rate of adverse effects, which were related primarily to local effects of inhaled glucocorticoids, was higher in the quadrupling group than in the non-quadrupling group.
CONCLUSIONS:In this trial involving adults and adolescents with asthma, a personalized self-management plan that included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate resulted in fewer severe asthma exacerbations than a plan in which the dose was not increased.
研究背景：哮喘急性加重严重威胁患者健康甚至生命。我们认为哮喘患者的自我管理计划（即在哮喘控制不佳早期应用4倍剂量吸入性糖皮质激素（ICS））可以减少成年人和青少年中严重哮喘急性加重的发生率，并对这一概念进行了验证。
方法：我们开展了一项真实世界，非盲，随机的试验，纳入正在接受ICS治疗，有或没有其他辅助治疗，并且在过去一年中至少有一次急性加重的成人和青少年哮喘患者。我们对进行自我管理计划的患者观察了12个月，并比较了4倍剂量ICS组（4倍组）与不增加ICS剂量组（非4倍组）的结果。主要研究终点是距首次发生严重哮喘急性加重的时间（即系统性应用糖皮质激素治疗或进行非计划性卫生保健咨询）。
结果：实验纳入1922名患者，随机分组，最终纳入分析了1871名患者数据。4倍ICS治疗组一年内发生严重哮喘急性加重的人数为420（45％），而非4倍组为484（52％），距首次发生重度急性加重时间的调整后风险比为0.81（95％CI[0.71-0.92], P = 0.002）。与ICS局部效应相关的不良反应发生率在4倍ICS治疗组高于非4倍组。
结论：在这项包括成人和青少年哮喘患者的试验中，实施个体化自我管理计划，即在哮喘控制不佳的早期开始，临时吸入4倍剂量的ICS治疗的患者比不增加ICS的患者其严重的哮喘急性加重的发生率有所降低。
(中国医科大学附属第一医院呼吸与危重症医学科 李文扬 摘译 杨冬 审校)
(McKeever T(1),et al N Engl J Med. 2018 Mar 8 Abstract)
(McKeever T(1),et al N Engl J Med. 2018 Mar 8 Abstract)
Quadrupling Inhaled Glucocorticoid Dose to Abort Asthma Exacerbations.
Abstract
BACKGROUND:Asthma exacerbations are frightening for patients and are occasionally fatal. We tested the concept that a plan for patients to manage their asthma (self-management plan), which included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate, would reduce the incidence of severe asthma exacerbations among adults and adolescents with asthma.
METHODS: We conducted a pragmatic, unblinded, randomized trial involving adults and adolescents with asthma who were receiving inhaled glucocorticoids, with or without add-on therapy, and who had had at least one exacerbation in the previous 12 months. We compared a self-management plan that included an increase in the dose of inhaled glucocorticoids by a factor of 4 (quadrupling group) with the same plan without such an increase (non-quadrupling group), over a period of 12 months. The primary outcome was the time to a first severe asthma exacerbation, defined as treatment with systemic glucocorticoids or an unscheduled health care consultation for asthma.
RESULTS:A total of 1922 participants underwent randomization, of whom 1871 were included in the primary analysis. The number of participants who had a severe asthma exacerbation in the year after randomization was 420 (45%) in the quadrupling group as compared with 484 (52%) in the non-quadrupling group, with an adjusted hazard ratio for the time to a first severe exacerbation of 0.81 (95% confidence interval, 0.71 to 0.92; P=0.002). The rate of adverse effects, which were related primarily to local effects of inhaled glucocorticoids, was higher in the quadrupling group than in the non-quadrupling group.
CONCLUSIONS:In this trial involving adults and adolescents with asthma, a personalized self-management plan that included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate resulted in fewer severe asthma exacerbations than a plan in which the dose was not increased.
上一篇：
ICS 和 LABA 作为控制及快速缓解治疗与持续性哮喘患者急性发作及症状控制之间的关系:一项系统性回顾 Meta 分析
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依据血EOS计数判定奥马珠单抗治疗重度过敏性哮喘的有效性：STELLAIR 研究
