Tiotropium in Early-Stage Chronic Obstructive Pulmonary Disease
Tiotropium in Early-Stage Chronic Obstructive Pulmonary Disease
复制标题
噻托溴铵在早期慢性阻塞性肺疾病中的应用
DOI：
10.1056/nejmoa1700228
复制
发表时间：
2017-09-07
影响因子：
158.5
通讯作者：
Ran, P.
中科院分区：
文献类型：
--
作者：
Zhou, Y.;Zhong, N.;Ran, P.
背景轻、中度慢性阻塞性肺疾病(COPD)患者很少接受药物治疗，因为他们几乎没有症状。在中国进行的一项多中心、随机、双盲、安慰剂对照试验中，我们随机将841例慢性阻塞性肺疾病全球倡议(GOLD)1期(轻度)或2级(中度)慢性阻塞性肺疾病患者随机分配给每日1次(18mU)的硫托品(419例)或与之匹配的安慰剂(422例)，为期2年。主要终点是使用支气管扩张剂前1秒用力呼气量(FEV1)从基线到24个月变化的组间差异。次要终点包括使用支气管扩张剂后FEV1从基线到24个月变化的组间差异和使用30天至24个月后FEV1年下降的组间差异。结果841名接受随机分组的患者中，硫托溴胺组388名患者和安慰剂组383名患者进入完全分析集。在整个试验期间，接受噻托溴铵治疗的患者的FEV1高于接受安慰剂治疗的患者(平均差异范围，使用支气管扩张剂前为127~169ml，使用后为71~133ml；P
BACKGROUNDPatients with mild or moderate chronic obstructive pulmonary disease (COPD) rarely receive medications, because they have few symptoms. We hypothesized that long-term use of tiotropium would improve lung function and ameliorate the decline in lung function in patients with mild or moderate COPD.METHODSIn a multicenter, randomized, double-blind, placebo-controlled trial that was conducted in China, we randomly assigned 841 patients with COPD of Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 1 (mild) or 2 (moderate) severity to receive a once-daily inhaled dose (18 mu g) of tiotropium (419 patients) or matching placebo (422) for 2 years. The primary end point was the between-group difference in the change from baseline to 24 months in the forced expiratory volume in 1 second (FEV 1) before bronchodilator use. Secondary end points included the between-group difference in the change from baseline to 24 months in the FEV 1 after bronchodilator use and the between-group difference in the annual decline in the FEV 1 before and after bronchodilator use from day 30 to month 24.RESULTSOf 841 patients who underwent randomization, 388 patients in the tiotropium group and 383 in the placebo group were included in the full analysis set. The FEV 1 in patients who received tiotropium was higher than in those who received placebo throughout the trial (ranges of mean differences, 127 to 169 ml before bronchodilator use and 71 to 133 ml after bronchodilator use; P