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氯沙坦治疗肺气肿的临床试验:肺试验合作组织氯沙坦对肺气肿进展的临床试验。

Clinical Trial of Losartan for Pulmonary Emphysema: Pulmonary Trials Cooperative Losartan Effects on Emphysema Progression Clinical Trial.

机构信息

Johns Hopkins University School of Medicine, Baltimore, Maryland.

Center for Clinical Trials and Evidence Synthesis, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.

出版信息

Am J Respir Crit Care Med. 2022 Oct 1;206(7):838-845. doi: 10.1164/rccm.202201-0206OC.

Abstract

There are no pharmacologic agents that modify emphysema progression in patients with chronic obstructive pulmonary disease (COPD). To evaluate the efficacy of losartan, an angiotensin receptor blocker, to reduce emphysema progression. The trial was a multicenter, randomized, placebo-controlled trial conducted between May 2017 and January 2021. Eligible participants were aged ⩾40 years, had moderate to severe airflow obstruction, ⩾10 pack-years of smoking, mild-moderate emphysema on high-resolution computed tomography, and no medical indication for or intolerance of angiotensin receptor blockers. Treatment with losartan 100 mg daily or matching placebo (1:1) was randomly assigned. The primary outcome was emphysema progression on high-resolution computed tomography over 48 weeks. Secondary outcomes included the St George's Respiratory Questionnaire, the modified Medical Research Council dyspnea scale, the COPD Assessment Test, and the Physical Function-Short Form 20a. A total of 220 participants were enrolled; 58% were men, 19% were African American, and 24% were current smokers. The medians (interquartile ranges) for age were 65 (61-73) years and 48 (36-59) for percent predicted FEV after bronchodilator use. The mean (95% confidence interval) percentage emphysema progression was 1.35% (0.67-2.03) in the losartan group versus 0.66% (0.09-1.23) in the placebo group ( = NS). Losartan did not prevent emphysema progression in people with COPD with mild-moderate emphysema. Clinical trial registered with www.clinicaltrials.gov (NCT02696564).

摘要

在慢性阻塞性肺疾病(COPD)患者中,没有药物可以改变肺气肿的进展。评估血管紧张素受体阻滞剂氯沙坦减少肺气肿进展的疗效。该试验是一项多中心、随机、安慰剂对照试验,于 2017 年 5 月至 2021 年 1 月进行。合格的参与者年龄 ⩾40 岁,有中重度气流阻塞, ⩾10 包年吸烟史,高分辨率计算机断层扫描显示轻度至中度肺气肿,并且没有使用血管紧张素受体阻滞剂的医学指征或不能耐受。每天给予氯沙坦 100 mg 或匹配的安慰剂(1:1)治疗,并随机分配。主要结局是 48 周时高分辨率计算机断层扫描上肺气肿的进展。次要结局包括圣乔治呼吸问卷、改良的医学研究委员会呼吸困难量表、COPD 评估测试和物理功能-20a 短表。共有 220 名参与者入组;58%为男性,19%为非裔美国人,24%为当前吸烟者。年龄中位数(四分位间距)分别为 65(61-73)岁和支气管扩张剂使用后预测的 FEV 的 48(36-59)%。氯沙坦组的平均(95%置信区间)肺气肿进展百分比为 1.35%(0.67-2.03),安慰剂组为 0.66%(0.09-1.23)( = NS)。氯沙坦不能预防轻度至中度肺气肿的 COPD 患者的肺气肿进展。临床试验在 www.clinicaltrials.gov 注册(NCT02696564)。

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