Landesklinikum Hochegg, Pulmologische Abteilung, Grimmenstein, Austria
Medical University Vienna, Dept of Emergency Medicine, Vienna, Austria.
Eur Respir J. 2021 Jul 29;58(1). doi: 10.1183/13993003.01798-2020. Print 2021 Jul.
Several studies have shown that statins have beneficial effects in COPD regarding lung function decline, rates and severity of exacerbation, hospitalisation and need for mechanical ventilation.
We performed a randomised double-blind placebo-controlled single-centre trial of simvastatin at a daily dose of 40 mg placebo in patients with Global Initiative for Chronic Obstructive Lung Disease criteria grades 2-4 at a tertiary care pulmonology department in Austria. Scheduled treatment duration was 12 months and the main outcome parameter was time to first exacerbation.
Overall, 209 patients were enrolled. In the 105 patients taking simvastatin, time to first exacerbation was significantly longer compared to the 104 patients taking placebo: median 341 140 days (log-rank test p<0.001). Hazard ratio for risk of first exacerbation for the simvastatin group was 0.51 (95% CI 0.34-0.75; p=0.001). Rate of exacerbations was significantly lower with simvastatin: 103 (41%) 147 (59%) (p=0.003). The annualised exacerbation rate was 1.45 events per patient-year in the simvastatin group and 1.9 events per patient-year in the placebo group (incidence rate ratio 0.77, 95% CI 0.60-0.99). We found no effect on quality of life, lung function, 6-min walk test and high-sensitivity C-reactive protein. More patients dropped out in the simvastatin group compared to the placebo group (39 29).
In our single-centre RCT, simvastatin at a dose of 40 mg daily significantly prolonged time to first COPD exacerbation and reduced exacerbation rate.
多项研究表明，他汀类药物对 COPD 患者的肺功能下降、加重率和严重程度、住院和机械通气需求有有益影响。
我们在奥地利一家三级护理肺病科进行了一项随机、双盲、安慰剂对照的单中心试验，研究了辛伐他汀（每天 40mg 安慰剂）对慢性阻塞性肺疾病全球倡议标准 2-4 级的患者的影响。计划治疗时间为 12 个月，主要观察指标为首次加重时间。
共有 209 例患者入组。在服用辛伐他汀的 105 例患者中，首次加重时间明显长于服用安慰剂的 104 例患者：中位数 341 140 天（对数秩检验，p<0.001）。辛伐他汀组首次加重风险的危险比为 0.51（95%可信区间 0.34-0.75；p=0.001）。服用辛伐他汀的患者发生加重的比例明显较低：103（41%） 147（59%）（p=0.003）。辛伐他汀组的年加重率为 1.45 例/患者年，安慰剂组为 1.9 例/患者年（发生率比为 0.77，95%可信区间 0.60-0.99）。我们没有发现对生活质量、肺功能、6 分钟步行试验和高敏 C 反应蛋白有影响。与安慰剂组相比，辛伐他汀组有更多的患者退出（39 29）。
在我们的单中心 RCT 中，辛伐他汀 40mg 每日剂量显著延长了 COPD 患者首次加重的时间，并降低了加重率。
