四倍吸入糖皮质激素治疗哮喘恶化
2018/05/08
摘要
背景：哮喘恶化对患者来说是非常可怕的，有时甚至是致命的。我们测试了一个概念，即一个病人管理哮喘的计划（自我管理计划），其中包括哮喘控制开始恶化时吸入的糖皮质激素剂量的临时翻两番，将减少成人和青少年严重哮喘恶化的发生率。
方法：我们进行了一项实用的、非盲的、随机试验，入组接受吸入糖皮质激素治疗的成人和青少年哮喘患者，无论有或无附加治疗的情况下，在过去的12个月内至少有一次急性发作。在12个月的时间内，我们比较了两组自我管理计划，两组基本管理计划相同，其中一组在哮喘发作时吸入糖皮质激素的剂量增加4倍（四倍组），另一组则无（非四倍组）。主要终点结果为哮喘第一次严重哮喘恶化的时间，严重恶化定义为实用全身糖皮质激素或非计划内的哮喘健康咨询。
结果：共有1922名受试者接受随机化，其中1871人被纳入初步分析。随机化后，一年内发生严重哮喘恶化的人数在四倍组中为420（45%），而非四倍组为484（52%），第一次严重恶化时间调整后的危险比为0.81（95%置信区间，0.71～0.92；P＝0.002）。不良反应的发生率与吸入糖皮质激素的局部效应有关，四倍组的不良反应发生率高于非四倍组。
结论：在这项涉及成人和青少年哮喘的试验中，一个个性化的自我管理计划，包括哮喘控制开始恶化时吸入的糖皮质激素剂量的临时翻两番，使哮喘恶化的严重程度较未使用吸入激素加倍的组轻。
Quadrupling Inhaled Glucocorticoid Dose to Abort Asthma Exacerbations.
McKeever T, Mortimer K, Wilson A, Walker S, Brightling C
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. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN15441965 .).
背景：哮喘恶化对患者来说是非常可怕的，有时甚至是致命的。我们测试了一个概念，即一个病人管理哮喘的计划（自我管理计划），其中包括哮喘控制开始恶化时吸入的糖皮质激素剂量的临时翻两番，将减少成人和青少年严重哮喘恶化的发生率。
方法：我们进行了一项实用的、非盲的、随机试验，入组接受吸入糖皮质激素治疗的成人和青少年哮喘患者，无论有或无附加治疗的情况下，在过去的12个月内至少有一次急性发作。在12个月的时间内，我们比较了两组自我管理计划，两组基本管理计划相同，其中一组在哮喘发作时吸入糖皮质激素的剂量增加4倍（四倍组），另一组则无（非四倍组）。主要终点结果为哮喘第一次严重哮喘恶化的时间，严重恶化定义为实用全身糖皮质激素或非计划内的哮喘健康咨询。
结果：共有1922名受试者接受随机化，其中1871人被纳入初步分析。随机化后，一年内发生严重哮喘恶化的人数在四倍组中为420（45%），而非四倍组为484（52%），第一次严重恶化时间调整后的危险比为0.81（95%置信区间，0.71～0.92；P＝0.002）。不良反应的发生率与吸入糖皮质激素的局部效应有关，四倍组的不良反应发生率高于非四倍组。
结论：在这项涉及成人和青少年哮喘的试验中，一个个性化的自我管理计划，包括哮喘控制开始恶化时吸入的糖皮质激素剂量的临时翻两番，使哮喘恶化的严重程度较未使用吸入激素加倍的组轻。
(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. 2018 Mar 8;378(10):902-910.)
(N Engl J Med. 2018 Mar 8;378(10):902-910.)
Quadrupling Inhaled Glucocorticoid Dose to Abort Asthma Exacerbations.
McKeever T, Mortimer K, Wilson A, Walker S, Brightling C
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. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN15441965 .).
上一篇：
英国哮喘患者口服皮质类固醇激素不良事件概况：队列研究与巢式病例对照分析
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信必可®维持和缓解治疗（SMART）以及GINA指南中哮喘管理的演变
