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背景和目的:吸入糖皮质激素和长效β受体激动剂已用于慢性阻塞性肺疾病(COPD)的治疗,但二者对患者死亡率的影响尚未明确。方法:来自42个国家、6112例 COPD 患者的双盲、随机、平行、安慰剂对照研究(TORCH),通过干粉吸入装置,一日两次分别吸入安慰剂,50μg沙美特罗、500μg丙酸氟替卡松或同时吸入50μg沙美特罗和500μg丙酸氟替卡松(联合治疗组),研究时间为3年。主要研究终点为联合治疗组与安慰剂组全因死亡率(不论致死原因)的差别,次要观察指标为各组间
BACKGROUND & AIM: Inhaled corticosteroids and long-acting beta-agonists have been used in the treatment of chronic obstructive pulmonary disease (COPD), but their impact on patient mortality has not been established. METHODS: A double-blind, randomized, parallel, placebo-controlled study (TORCH) of 6112 patients with COPD in 42 countries was administered with a placebo, 50 μg salmeterol, 500 μg fluticasone propionate Or inhalation of 50 μg salmeterol and 500 μg fluticasone propionate (combination therapy group) for a duration of 3 years. The primary end point was the difference in all-cause mortality (regardless of cause of death) between the combination and placebo groups. The secondary outcome measures were inter-group