Oxidative stress contributes to chronic obstructive pulmonary disease (COPD) exacerbations and antioxidants can decrease exacerbation rates, although we lack data about the effect of such drugs on exacerbation duration. The RESTORE (Reducing Exacerbations and Symptoms by Treatment with ORal Erdosteine in COPD) study was a prospective randomised, double-blind, placebo-controlled study, enrolling patients aged 40–80 years with Global Initiative for Chronic Obstructive Lung Disease stage II/III. Patients received erdosteine 300 mg twice daily or placebo added to usual COPD therapy for 12 months. The primary outcome was the number of acute exacerbations during the study. In the pre-specified intention-to-treat population of 445 patients (74% male; mean age 64.8 years, forced expiratory volume in 1 s 51.8% predicted) erdosteine reduced the exacerbation rate by 19.4% (0.91 versus. 1.13 exacerbations·patient−1·year−1 for erdosteine and placebo, respectively; p=0.01), due to an effect on mild events; the reduction in the rate of mild exacerbations was 57.1% (0.23 versus 0.54 exacerbations·patient−1·year−1 for erdosteine and placebo, respectively; p=0.002). No significant difference was observed in the rate of moderate and severe exacerbations (0.68 versus 0.59 exacerbations·patient−1·year−1 for erdosteine and placebo, respectively; p=0.054) despite a trend in favour of the comparison group. Erdosteine decreased the exacerbation duration irrespective of event severity by 24.6% (9.55 versus 12.63 days for erdosteine and placebo, respectively; p=0.023). Erdosteine significantly improved subject and physician subjective severity scores (p=0.022 and p=0.048, respectively), and reduced the use of reliever medication (p<0.001), but did not affect the St George's Respiratory Questionnaire score or the time to first exacerbation. In patients with COPD, erdosteine can reduce both the rate and duration of exacerbations. The percentage of patients with adverse events was similar in both the placebo and erdosteine treatment groups. RESTORE study: erdosteine reduces both rate and duration of COPD exacerbations with a placebo-like safety profile http://ow.ly/BbGI30dRdEt

中文翻译：

---

厄多司坦对 COPD 急性加重率和持续时间的影响：RESTORE 研究

氧化应激会导致慢性阻塞性肺疾病 (COPD) 恶化，抗氧化剂可以降低恶化率，尽管我们缺乏关于此类药物对恶化持续时间影响的数据。RESTORE（通过口服厄多司坦治疗减少 COPD 中的急性加重和症状）研究是一项前瞻性随机、双盲、安慰剂对照研究，招募了 40-80 岁慢性阻塞性肺疾病全球倡议 II/III 期患者。患者接受厄多司坦 300 毫克每天两次或安慰剂加入常规 COPD 治疗 12 个月。主要结果是研究期间急性加重的次数。在预先指定的 445 名患者的意向治疗人群中（74% 为男性；平均年龄 64.8 岁，1 秒 51 内用力呼气量。8% 预测）厄多司坦降低了 19.4% 的恶化率（厄多司坦和安慰剂分别为 0.91 和 1.13 次恶化·患者-1·年-1；p=0.01），这是由于对轻度事件的影响；轻度加重率降低了 57.1%（厄多司坦和安慰剂分别为 0.23 和 0.54 加重·患者-1·年-1；p=0.002）。尽管有利于对照组的趋势，但在中度和重度恶化率中没有观察到显着差异（厄多司坦和安慰剂分别为 0.68 和 0.59 恶化·患者-1·年-1；p=0.054）。无论事件严重程度如何，厄多司坦都将恶化持续时间缩短了 24.6%（厄多司坦和安慰剂分别为 9.55 天和 12.63 天；p=0.023）。厄多司坦显着改善了受试者和医生的主观严重程度评分（p=0.022 和 p=0。048），并减少了缓解药物的使用（p<0.001），但不影响圣乔治呼吸问卷评分或首次恶化的时间。在 COPD 患者中，厄多司坦可降低急性加重的发生率和持续时间。安慰剂组和厄多司坦治疗组发生不良事件的患者百分比相似。RESTORE 研究：厄多司坦降低 COPD 急性加重的发生率和持续时间，具有类似安慰剂的安全性 http://ow.ly/BbGI30dRdEt 安慰剂组和厄多司坦治疗组发生不良事件的患者百分比相似。RESTORE 研究：厄多司坦降低 COPD 急性加重的发生率和持续时间，具有类似安慰剂的安全性 http://ow.ly/BbGI30dRdEt 安慰剂组和厄多司坦治疗组发生不良事件的患者百分比相似。RESTORE 研究：厄多司坦降低 COPD 急性加重的发生率和持续时间，具有类似安慰剂的安全性 http://ow.ly/BbGI30dRdEt