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在 COPD 患者停用 LABA/ICS 后升级至三联疗法与转换至双联支气管扩张剂相比的疗效和安全性:一项回顾性队列研究。

Comparative effectiveness and safety of escalating to triple therapy versus switching to dual bronchodilators after discontinuing LABA/ICS in patients with COPD: a retrospective cohort study.

机构信息

School of Pharmacy, National Defense Medical Center, Taipei, Taiwan, Republic of China.

Department of Pharmacy, National Yang Ming Chiao Tung University, Taipei, Taiwan, Republic of China.

出版信息

Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241292242. doi: 10.1177/17534666241292242.

DOI:10.1177/17534666241292242
PMID:39491813
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11533288/
Abstract

BACKGROUND

The latest guidelines discourage the use of long-acting beta-agonists/inhaled corticosteroids (LABA/ICS) for chronic obstructive pulmonary disease (COPD). However, there is a lack of evidence regarding the optimal subsequent treatment after discontinuing LABA/ICS.

OBJECTIVES

To compare the effectiveness and safety of switching from LABA/ICS to triple therapy (LABA/long-acting muscarinic antagonists (LAMA)/ICS) or to dual bronchodilators (LABA/LAMA) in COPD patients.

DESIGN

This was a new-user, active-comparator, and propensity score-matched cohort study analyzing the Taiwanese nationwide healthcare insurance claims.

METHODS

We recruited COPD patients switching from LABA/ICS to triple therapy or to dual bronchodilators from 2015 to 2019. The primary effectiveness outcome was the annual rate of exacerbations, and safety outcomes included severe pneumonia and all-cause mortality. Stratification by prior exacerbations was conducted.

RESULTS

After matching, each group comprised 1892 patients, 55% of whom experienced no exacerbations in the prior year. Treatment with LABA/LAMA/ICS versus LABA/LAMA showed comparable annual rate of moderate-to-severe exacerbations (incidence rate ratio, 1.04; 95% confidence interval (CI), 0.91-1.19). However, switching to LABA/LAMA/ICS was associated with increased risks of severe pneumonia (hazard ratio (HR), 1.65; 95% CI, 1.30-2.09) and all-cause death (HR, 1.39; 95% CI, 1.09-1.78). In patients with⩾2 prior exacerbations, LABA/LAMA/ICS versus LABA/LAMA was related to a 21% reduced rate of exacerbations but with a twofold increased pneumonia risk and a 49% elevated risk of all-cause mortality.

CONCLUSION

Switching from LABA/ICS to triple therapy versus dual bronchodilators in COPD patients was associated with similar rates of annual exacerbations but was related to elevated risks of severe pneumonia and all-cause mortality. Among frequent exacerbators, triple therapy was associated with lower rates of exacerbation but was accompanied by increased risks of pneumonia and mortality compared to LABA/LAMA. Careful consideration of the examined safety events is necessary when switching from LABA/ICS to triple therapy in COPD management.

摘要

背景

最新指南不建议将长效β-激动剂/吸入皮质类固醇(LABA/ICS)用于慢性阻塞性肺疾病(COPD)。然而,停止使用 LABA/ICS 后,最佳的后续治疗方案尚缺乏证据。

目的

比较 COPD 患者从 LABA/ICS 转换为三联疗法(LABA/长效毒蕈碱拮抗剂(LAMA)/ICS)或双支气管扩张剂(LABA/LAMA)的有效性和安全性。

设计

这是一项新用户、活性对照和倾向评分匹配的队列研究,分析了台湾全民健康保险理赔数据。

方法

我们招募了 2015 年至 2019 年期间从 LABA/ICS 转换为三联疗法或双支气管扩张剂的 COPD 患者。主要有效性结局为每年加重率,安全性结局包括严重肺炎和全因死亡率。对既往加重情况进行分层。

结果

匹配后,每组各有 1892 例患者,其中 55%的患者在前一年无加重。与 LABA/LAMA/ICS 相比,LABA/LAMA 的每年中重度加重率相当(发生率比,1.04;95%置信区间(CI),0.91-1.19)。然而,转换为 LABA/LAMA/ICS 与严重肺炎风险增加相关(风险比(HR),1.65;95%CI,1.30-2.09)和全因死亡风险增加(HR,1.39;95%CI,1.09-1.78)。在既往加重次数≥2 的患者中,与 LABA/LAMA 相比,LABA/LAMA/ICS 可使加重率降低 21%,但肺炎风险增加两倍,全因死亡率增加 49%。

结论

在 COPD 患者中,从 LABA/ICS 转换为三联疗法与双支气管扩张剂相比,每年加重率相当,但严重肺炎和全因死亡率风险增加。在频繁加重的患者中,三联疗法与较低的加重率相关,但与 LABA/LAMA 相比,肺炎和死亡率风险增加。在 COPD 管理中从 LABA/ICS 转换为三联疗法时,需要仔细考虑所检查的安全性事件。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/579b/11533288/14dc217a4560/10.1177_17534666241292242-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/579b/11533288/fd643901be55/10.1177_17534666241292242-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/579b/11533288/7d1627875903/10.1177_17534666241292242-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/579b/11533288/14dc217a4560/10.1177_17534666241292242-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/579b/11533288/fd643901be55/10.1177_17534666241292242-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/579b/11533288/7d1627875903/10.1177_17534666241292242-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/579b/11533288/14dc217a4560/10.1177_17534666241292242-fig3.jpg

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