From the Department of Epidemiology and Public Health (T.M.) and the Nottingham Respiratory Research Unit (T.H.), National Institute for Health Research (NIHR) Biomedical Research Centre, and the Nottingham Clinical Trials Unit (A.S., L.D., L.B., R.H., E.M.), University of Nottingham, Nottingham, the Liverpool School of Tropical Medicine and Aintree University Hospital, Liverpool (K.M.), the University of Leicester (A.W.) and the Leicester NIHR Biomedical Research Centre, University of Leicester (C.B.), Leicester, Asthma UK, London (S.W.), the Respiratory Medicine Unit and Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford (I.P.), the Centre of Academic Primary Care (D.P.) and the Institute of Medical Sciences (G.D.), University of Aberdeen, Aberdeen, the Primary Care and Population Science and NIHR Southampton Biomedical Research Centre, University of Southampton, Southampton (M.T.), and the Department of Respiratory Medicine, Newcastle upon Tyne Hospitals NHS Trust, Newcastle upon Tyne (B.H.) - all in the United Kingdom.
N Engl J Med. 2018 Mar 8;378(10):902-910. doi: 10.1056/NEJMoa1714257. Epub 2018 Mar 3.
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.
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.
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.
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 .).
哮喘加重令患者感到恐惧，有时甚至危及生命。我们对一个概念进行了检验，即制定一个患者管理哮喘的方案（自我管理计划），当哮喘控制开始恶化时，该方案包括临时将吸入性糖皮质激素的剂量增加四倍，如果患者为成年人或青少年且患有哮喘，该方案将降低其哮喘重度恶化的发生率。
我们进行了一项实用、非盲、随机试验，纳入了正在接受吸入性糖皮质激素治疗（含或不含附加治疗）且在过去 12 个月中有至少一次加重的成年人和青少年哮喘患者。我们比较了一个自我管理计划，其中包括将吸入性糖皮质激素的剂量增加四倍（增加组），与没有这种增加的相同计划（非增加组），为期 12 个月。主要结局是首次重度哮喘恶化的时间，定义为接受全身糖皮质激素治疗或因哮喘进行计划外的卫生保健咨询。
共有 1922 名参与者接受了随机分组，其中 1871 名参与者纳入主要分析。在随机分组后 1 年内，增加组中有 420 名（45%）参与者发生重度哮喘恶化，而非增加组中有 484 名（52%）参与者发生重度哮喘恶化，首次重度恶化的时间调整风险比为 0.81（95%置信区间，0.71 至 0.92；P=0.002）。与非增加组相比，增加组中与吸入性糖皮质激素局部作用相关的不良事件发生率更高。
在这项涉及成年人和青少年哮喘患者的试验中，与不增加剂量的方案相比，当哮喘控制开始恶化时，包含临时将吸入性糖皮质激素剂量增加四倍的个性化自我管理计划可减少重度哮喘恶化的发生。（由英国国家卫生与临床优化研究所卫生技术评估计划资助；当前对照试验编号，ISRCTN83003314。）
