Abstract
Patients with acute exacerbations of chronic obstructive pulmonary disease (AECOPD) were treated with immediate or sequential withdrawal after 5 days of systemic glucocorticoids. The effects of the two withdrawal methods on the prognosis of patients were compared at 30, 90, 180, and 360 days after discharge. A multicenter, randomized, double-blind, parallel-controlled, open-label study was conducted in the respiratory department of tertiary hospitals in Central China. Patients met inclusion criteria for AECOPD and needed to use systemic glucocorticoids. They were randomly assigned to immediate and sequential withdrawal groups at a 1:1 ratio. The study was completed in August 2020 and is registered at the China Clinical Trials Registry (Chictr.org) (ChiCTR1800018894). According to general data and clinical characteristics, there were no statistically significant differences between the 329 patients in the immediate withdrawal group and the 310 patients in the sequential withdrawal group (P > 0.05). At the 30, 90, 180, and 360-days follow-up, the acute exacerbation frequency, rehospitalization rate, mortality, and intensive care unit (ICU) treatment rate were not significantly different between the immediate withdrawal group and sequential withdrawal group (P > 0.05). The modified Medical Research Council (mMRC) and COPD assessment test (CAT) scores were also not significantly different between the two groups. At the 180- and 360-day follow-up, forced expiratory volume in 1 s (FEV1%) and peak expiratory flow (PEF) were not significantly different between the two groups (P > 0.05). The time from discharge to first acute exacerbation was significantly lower in the immediate withdrawal group (46.12 days) than in sequential withdrawal group (49.02 days) (P < 0.05). The time of stay in the hospital for the first time after discharge was not significantly different between the two groups (P > 0.05). Adverse events were not significantly different between the immediate withdrawal group and sequential withdrawal group (P < 0.05). Subgroup analysis was performed according to age, degree of disease, and relevant indicators. At the 30-day follow-up, the acute exacerbation frequency of patients with advanced age, high global strategy for chronic obstructive lung disease (GOLD), and high fractional exhaled nitric oxide was significantly higher in the immediate withdrawal group than in the sequential withdrawal group (P < 0.05). In addition, according to receiver operating characteristic (ROC) curve analysis, the frequency of acute exacerbations at the 30-day follow-up was significantly higher in patients with age > 63.5 years or GOLD > 3 in the immediate withdrawal group than in the sequential withdrawal group, suggesting that the short-term efficacy was poor.
Highlights
Chronic obstructive pulmonary disease (COPD) is a chronic, non-specific disease in which inflammation of the airways activates inflammatory epithelial and smooth muscle cells and the release of inflammatory mediators (Doumas et al, 2020)
The Global Strategy for Chronic Obstructive Lung Disease (GOLD) guide indicates that glucocorticoids can shorten recovery time and improve lung function and hypoxia during acute exacerbations, in addition to reducing the risk of recurrence and disease progression (Burns et al, 2020)
A multicenter, randomized, double-blind, parallel-controlled study was conducted in tertiary hospitals in Central China to compare the effects of systemic glucocorticoid immediate or sequential withdrawal on the prognosis of Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) patients at 30, 90, 180, and 360 days after discharge
Summary
Chronic obstructive pulmonary disease (COPD) is a chronic, non-specific disease in which inflammation of the airways activates inflammatory epithelial and smooth muscle cells and the release of inflammatory mediators (Doumas et al, 2020). Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) occur when COPD patients show rapid changes within a short period (Vermeersch et al, 2019), with obvious aggravation of clinical symptoms such as cough, sputum production, dyspnea, and shortness of breath. The Global Strategy for Chronic Obstructive Lung Disease (GOLD) guide indicates that glucocorticoids can shorten recovery time and improve lung function and hypoxia during acute exacerbations, in addition to reducing the risk of recurrence and disease progression (Burns et al, 2020). The GOLD guide recommends methyl prednisone at 40 mg/d for 5 days in cases of AECOPD (Leuppi et al, 2013)
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