非嗜酸细胞性哮喘患者吸入糖皮质激素的降级治疗：现实世界的前瞻性试验
2018/05/30
摘要
背景：虽然非嗜酸细胞性哮喘通常被认为对吸入糖皮质激素（ICS）反应不佳，但目前还缺乏对此类人群ICS降级治疗的评价性研究。
目的：估测停止ICS治疗后不存在临床恶化的风险的非嗜酸细胞性哮喘患者的比例，并确定停止ICS治疗会失败的预测指标。
方法：这项前瞻性研究由36名非嗜酸细胞性哮喘患者完成，非嗜酸细胞性哮喘定义为痰嗜酸性粒细胞<3％，血嗜酸性粒细胞<400 /μL。 在这些患者中，无论基线哮喘控制水平如何，ICS的剂量每3个月逐渐降低，直至达到失败标准或成功停用ICS 6个月。 失败标准是ACQ评分≥1.5，较基线增加> 0.5或在研究期间严重恶化的次数大于基线访视前一年的次数。 构建受试者工作特征（ROC）曲线来评估不能停用ICS的预测因子。
结果：14例患者（39％）完全停用ICS。在另外10名患者（28％）中，ICS减少至较低剂量，而哮喘控制和急性发作率没有任何恶化。高龄（ROC曲线下面积[ROC AUC]和[95％CI]：0.77 [0.62-0.93]）和血液嗜酸性粒细胞升高（ROC AUC [95％CI]：0.77 [0.61-0.93]）是不能停用ICS治疗的基线预测因子。 ICS第一次降级后，最好的预测因子是嗜酸性粒细胞计数升高（ROC AUC [95％CI]：0.85 [0.72-0.99]）。
结论：无论基线哮喘控制如何，在非嗜酸细胞增多型哮喘患者中，三分之二的患者能够撤药或减少ICS剂量。 升高的血液嗜酸性粒细胞计数是停药失败的预测因子。
Step-down of inhaled corticosteroids in non-eosinophilic asthma: a prospective trial in real life
Demarche S, Schleich F, Henket M, Paulus V, Louis R, Van Hees T..
Abstract
BACKGROUND:While non-eosinophilic asthmatics are usually considered poorly responsive to inhaled corticosteroids (ICS), studies assessing a step-down of ICS in this specific population are currently lacking.
OBJECTIVE:To assess the proportion of non-eosinophilic asthmatics in whom ICS may be withdrawn without any clinical degradation and to determine the predictive markers of a failure to stop treatment with ICS.
METHODS:This prospective study was completed by 36 non-eosinophilic asthmatics, defined by sputum eosinophils <3% and blood eosinophils <400/μL. In these patients, whichever the baseline asthma control level, the dose of ICS was gradually reduced every 3 months until they met the failure criteria or successfully discontinued ICS for 6 months. The failure criteria were an ACQ score ≥1.5 with an increase from baseline >0.5 or a number of severe exacerbations during the study which was greater than the number during the year prior to the baseline visit. Receiver-operating characteristic (ROC) curves were constructed to assess predictors of a failure to stop ICS.
RESULTS:In 14 patients (39%), ICS were completely withdrawn and in 10 further patients (28%), ICS were stepped-down to a reduced ICS dose without any deterioration of asthma control and exacerbation rate. Baseline predictors of a failure to stop ICS were a greater age (area under ROC curve [ROC AUC] and [95% CI]: 0.77 [0.62-0.93]) and elevated blood eosinophils (ROC AUC [95% CI]: 0.77 [0.61-0.93]). After the first step-down of ICS, the best predictor was an elevated blood eosinophil count (ROC AUC [95% CI]: 0.85 [0.72-0.99]).
CONCLUSIONS:Withdrawing or reducing the dose of ICS is feasible in two thirds of non-eosinophilic asthmatics irrespective of baseline asthma control. An elevated blood eosinophil count may predict the failure to stop ICS.
背景：虽然非嗜酸细胞性哮喘通常被认为对吸入糖皮质激素（ICS）反应不佳，但目前还缺乏对此类人群ICS降级治疗的评价性研究。
目的：估测停止ICS治疗后不存在临床恶化的风险的非嗜酸细胞性哮喘患者的比例，并确定停止ICS治疗会失败的预测指标。
方法：这项前瞻性研究由36名非嗜酸细胞性哮喘患者完成，非嗜酸细胞性哮喘定义为痰嗜酸性粒细胞<3％，血嗜酸性粒细胞<400 /μL。 在这些患者中，无论基线哮喘控制水平如何，ICS的剂量每3个月逐渐降低，直至达到失败标准或成功停用ICS 6个月。 失败标准是ACQ评分≥1.5，较基线增加> 0.5或在研究期间严重恶化的次数大于基线访视前一年的次数。 构建受试者工作特征（ROC）曲线来评估不能停用ICS的预测因子。
结果：14例患者（39％）完全停用ICS。在另外10名患者（28％）中，ICS减少至较低剂量，而哮喘控制和急性发作率没有任何恶化。高龄（ROC曲线下面积[ROC AUC]和[95％CI]：0.77 [0.62-0.93]）和血液嗜酸性粒细胞升高（ROC AUC [95％CI]：0.77 [0.61-0.93]）是不能停用ICS治疗的基线预测因子。 ICS第一次降级后，最好的预测因子是嗜酸性粒细胞计数升高（ROC AUC [95％CI]：0.85 [0.72-0.99]）。
结论：无论基线哮喘控制如何，在非嗜酸细胞增多型哮喘患者中，三分之二的患者能够撤药或减少ICS剂量。 升高的血液嗜酸性粒细胞计数是停药失败的预测因子。
(中日友好医院呼吸与危重症医学科 张科文 摘译 林江涛 审校)
(Clin Exp Allergy. 2018 Jan 31. doi: 10.1111/cea.13106)
(Clin Exp Allergy. 2018 Jan 31. doi: 10.1111/cea.13106)
Step-down of inhaled corticosteroids in non-eosinophilic asthma: a prospective trial in real life
Demarche S, Schleich F, Henket M, Paulus V, Louis R, Van Hees T..
Abstract
BACKGROUND:While non-eosinophilic asthmatics are usually considered poorly responsive to inhaled corticosteroids (ICS), studies assessing a step-down of ICS in this specific population are currently lacking.
OBJECTIVE:To assess the proportion of non-eosinophilic asthmatics in whom ICS may be withdrawn without any clinical degradation and to determine the predictive markers of a failure to stop treatment with ICS.
METHODS:This prospective study was completed by 36 non-eosinophilic asthmatics, defined by sputum eosinophils <3% and blood eosinophils <400/μL. In these patients, whichever the baseline asthma control level, the dose of ICS was gradually reduced every 3 months until they met the failure criteria or successfully discontinued ICS for 6 months. The failure criteria were an ACQ score ≥1.5 with an increase from baseline >0.5 or a number of severe exacerbations during the study which was greater than the number during the year prior to the baseline visit. Receiver-operating characteristic (ROC) curves were constructed to assess predictors of a failure to stop ICS.
RESULTS:In 14 patients (39%), ICS were completely withdrawn and in 10 further patients (28%), ICS were stepped-down to a reduced ICS dose without any deterioration of asthma control and exacerbation rate. Baseline predictors of a failure to stop ICS were a greater age (area under ROC curve [ROC AUC] and [95% CI]: 0.77 [0.62-0.93]) and elevated blood eosinophils (ROC AUC [95% CI]: 0.77 [0.61-0.93]). After the first step-down of ICS, the best predictor was an elevated blood eosinophil count (ROC AUC [95% CI]: 0.85 [0.72-0.99]).
CONCLUSIONS:Withdrawing or reducing the dose of ICS is feasible in two thirds of non-eosinophilic asthmatics irrespective of baseline asthma control. An elevated blood eosinophil count may predict the failure to stop ICS.
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长效β2-激动剂治疗哮喘的安全性试验综合分析
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重症哮喘中降低奥马珠单抗反应的因素
