Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK.
Respiratory Medicine, University of Ferrara, Ferrara, Italy.
Int J Chron Obstruct Pulmon Dis. 2022 Aug 22;17:1909-1920. doi: 10.2147/COPD.S369804. eCollection 2022.
To explore the effect of erdosteine on COPD exacerbations, health-related quality of life (HRQoL), and subjectively assessed COPD severity.
This post-hoc analysis of the RESTORE study included participants with COPD and spirometrically moderate (GOLD 2; post-bronchodilator forced expiratory volume in 1 second [FEV] 50‒79% predicted; n = 254), or severe airflow limitation (GOLD 3; post-bronchodilator FEV 30‒49% predicted; n = 191) who received erdosteine 300 mg twice daily or placebo added to usual maintenance therapy for 12 months. Antibiotic and oral corticosteroid use was determined together with patient-reported HRQoL (St George's Respiratory Questionnaire, SGRQ). Patient and physician subjective COPD severity scores (scale 0‒4) were rated at baseline, 6 and 12 months. Data were analyzed using descriptive statistics for exacerbation severity, COPD severity, and treatment group. Comparisons between treatment groups used Student's -tests or ANCOVA as appropriate.
Among GOLD 2 patients, 43 of 126 erdosteine-treated patients exacerbated (7 moderate-to-severe exacerbations), compared to 62 of 128 placebo-treated patients (14 moderate-to-severe exacerbations). Among those with moderate-to-severe exacerbations, erdosteine-treated patients had a shorter mean duration of corticosteroid treatment (11.4 days vs 13.3 days for placebo, = 0.043), and fewer patients required antibiotic treatment with/without oral corticosteroids (71.4% vs 85.8% for placebo, < 0.001). Erdosteine-treated GOLD 2 patients who exacerbated showed significant improvements from baseline in SGRQ total scores and subjective disease severity scores (patient- and physician-rated), compared with placebo-treated patients regardless of exacerbation severity. Among GOLD 3 patients, there were no significant differences between treatment groups on any of these measures.
Adding erdosteine to the usual maintenance therapy of COPD patients with moderate airflow limitation reduced the number of exacerbations, the duration of treatment with corticosteroids and the episodes requiring treatment with antibiotics. Additionally, treatment with erdosteine improved HRQoL and patient-reported disease severity.
探讨厄多司坦对慢性阻塞性肺疾病（COPD）加重、健康相关生活质量（HRQoL）以及主观评估的 COPD 严重程度的影响。
这项 RESTORE 研究的事后分析纳入了 COPD 患者，这些患者的肺功能检测为中重度气流受限（GOLD 2 级；支气管扩张剂后 1 秒用力呼气量[FEV]占预计值的 50%至 79%，n=254）或重度气流受限（GOLD 3 级；支气管扩张剂后 FEV 占预计值的 30%至 49%，n=191），他们接受厄多司坦 300mg 每日两次或安慰剂，联合常规维持治疗 12 个月。通过抗生素和口服皮质类固醇的使用情况以及患者报告的 HRQoL（圣乔治呼吸问卷[SGRQ]）来确定结果。在基线、6 个月和 12 个月时，评估患者和医生主观 COPD 严重程度评分（0 至 4 分）。使用描述性统计方法分析加重严重程度、COPD 严重程度和治疗组之间的差异。使用 Student's t 检验或协方差分析（ANCOVA）比较治疗组间的差异。
在 GOLD 2 级患者中，厄多司坦治疗的 126 例患者中有 43 例（7 例为中重度加重），而安慰剂治疗的 128 例患者中有 62 例（14 例为中重度加重）。在中重度加重的患者中，厄多司坦治疗的患者皮质类固醇治疗的平均持续时间更短（11.4 天比安慰剂组的 13.3 天， = 0.043），需要抗生素治疗的患者更少（联合或不联合口服皮质类固醇，厄多司坦组为 71.4%，安慰剂组为 85.8%， < 0.001）。厄多司坦治疗的 GOLD 2 级加重患者，与安慰剂治疗的患者相比，无论加重严重程度如何，SGRQ 总分和主观疾病严重程度评分（患者和医生评估）均有显著改善。在 GOLD 3 级患者中，在这些指标上，两组之间没有显著差异。
在中重度气流受限的 COPD 患者的常规维持治疗中添加厄多司坦可减少加重次数、皮质类固醇治疗的持续时间和需要抗生素治疗的发作。此外，厄多司坦治疗可改善 HRQoL 和患者报告的疾病严重程度。
