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比较 COPD 患者吸入皮质类固醇和长效β激动剂联合治疗的安全性和有效性。

Comparative Safety and Effectiveness of Inhaled Corticosteroid and Long-Acting β-Agonist Combinations in Patients With COPD.

机构信息

Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.

Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.

出版信息

Chest. 2020 May;157(5):1117-1129. doi: 10.1016/j.chest.2019.12.006. Epub 2019 Dec 28.

Abstract

BACKGROUND

The differential risk of pneumonia among inhaled corticosteroid (ICS) use in patients with COPD requires more investigation, especially regarding beclomethasone-containing inhalers. The goal of this study was to compare the risk and benefit profile of different ICS/long-acting β-agonist (LABA) combinations in patients with COPD.

METHODS

This retrospective cohort study was conducted by using national health insurance claims data from the years 2009 to 2015 in Taiwan and included patients with COPD with new ICS/LABA use. Propensity score matching and Cox regression models were used to estimate the hazard ratios of severe pneumonia and acute exacerbation for different ICS/LABA users.

RESULTS

Both budesonide/formoterol (BUD/FOR) dry-powder inhalers and beclomethasone/formoterol (BEC/FOR) metered-dose inhalers, compared with fluticasone propionate/salmeterol (FLU/SAL) delivered via the same device type, were associated with a lower risk of severe pneumonia (BUD/FOR hazard ratio [HR], 0.83 [95% CI, 0.70-0.98]; BEC/FOR HR, 0.69 [95% CI, 0.58-0.81]) and severe acute exacerbation (BUD/FOR HR, 0.88 [95% CI, 0.78-0.99]; BEC/FOR HR, 0.82 [95% CI, 0.72-0.93]). After additionally adjusting for the average daily ICS dose, BUD/FOR dry-powder inhaler users continued to have a significantly decreased risk of severe pneumonia (18%), although BEC/FOR metered-dose inhaler users did not. The results were consistent in most of the prespecified subgroups and across all the sensitivity analyses.

CONCLUSIONS

This study augments the existing evidence concerning the different safety and effectiveness outcomes of ICS/LABA combinations in patients with COPD, which may be considered when making clinical treatment decisions.

摘要

背景

在 COPD 患者中,吸入性皮质类固醇(ICS)的使用的肺炎差异风险需要更多的研究,尤其是针对含有倍氯米松的吸入器。本研究的目的是比较 COPD 患者中不同 ICS/长效β-激动剂(LABA)组合的风险和获益情况。

方法

本回顾性队列研究使用了 2009 年至 2015 年台湾的国家健康保险理赔数据,纳入了新使用 ICS/LABA 的 COPD 患者。使用倾向评分匹配和 Cox 回归模型来估计不同 ICS/LABA 使用者发生严重肺炎和急性加重的风险比。

结果

与相同装置类型的丙酸氟替卡松/沙美特罗(FLU/SAL)相比,布地奈德/福莫特罗(BUD/FOR)干粉吸入剂和倍氯米松/福莫特罗(BEC/FOR)计量吸入器均与严重肺炎的风险降低相关(BUD/FOR 的风险比 [HR],0.83 [95%CI,0.70-0.98];BEC/FOR HR,0.69 [95%CI,0.58-0.81])和严重急性加重(BUD/FOR HR,0.88 [95%CI,0.78-0.99];BEC/FOR HR,0.82 [95%CI,0.72-0.93])。在进一步调整平均每日 ICS 剂量后,BUD/FOR 干粉吸入器使用者仍然显著降低了严重肺炎的风险(18%),尽管 BEC/FOR 计量吸入器使用者没有。这些结果在大多数预先指定的亚组和所有敏感性分析中均一致。

结论

本研究增加了有关 COPD 患者中 ICS/LABA 组合的不同安全性和有效性结果的现有证据,在做出临床治疗决策时可能需要考虑这些证据。

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