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真实世界临床实践中,双重支气管扩张剂治疗对慢性阻塞性肺疾病既往和现吸烟者急性加重的获益:一项多中心验证研究(TOReTO)。

Benefit of dual bronchodilator therapy on exacerbations in former and current smokers with chronic obstructive pulmonary disease in real-world clinical practice: a multicenter validation study (TOReTO).

机构信息

Division of Pulmonary Medicine, Department of Internal Medicine, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chiayi, Taiwan.

Department of Pulmonary and Critical Care Medicine, Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation, Taoyuan, Taiwan.

出版信息

Respir Res. 2024 Oct 17;25(1):377. doi: 10.1186/s12931-024-02971-3.

Abstract

BACKGROUND

Dual bronchodilator therapy, consisting of a long-acting beta-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), has proven effective for patients with chronic obstructive pulmonary disease (COPD). However, it remains uncertain whether there are efficacy differences between current and former smokers with COPD. This study aims to explore the effectiveness of LABA/LAMA therapies in both these groups.

METHODS

The TOReTO trial assessed lung function, symptoms, health status, the occurrence of exacerbations, clinically significant exacerbations, and the use of LABA/LAMA therapies. These therapies include Tio/Olo, umeclidinium/vilanterol (Umec/Vi), and umeclidinium/vilanterol (Umec/Vi) are used in patients with COPD. The study examined the differences in outcomes between current and former smokers. To balance the baseline characteristics, propensity score matching (PSM) was employed.

RESULTS

Data from 967 patients were collected. After PSM, the time to the first acute exacerbation in current smokers was analyzed separately for the three treatment groups and was significantly different between them (p = 0.0457). Among, there are differences in the occurrence of acute exacerbation between treatment and smoking status in Umec/Vi (p = 0.0114). There is no significant difference in the treatment of former smokers among the three different groups of LABA/LAMA fixed-dose combinations (p = 0.3079). COPD-related symptoms remained stable throughout the treatment period. There were no significant differences in symptom scores, including CAT and mMRC, among the three groups at the end of the study.

CONCLUSIONS

The three fixed-dose combinations of LABA/LAMA showed no difference in reducing exacerbations in former smokers but did show differences in current smokers. This trend has clinical significance, and future research will be conducted to control influencing variables to validate this point. However, due to the non-randomized study design, these findings should be interpreted with caution.

摘要

背景

长效β激动剂(LABA)和长效抗胆碱能拮抗剂(LAMA)的双联支气管扩张剂疗法已被证明对慢性阻塞性肺疾病(COPD)患者有效。然而,目前仍不确定 COPD 患者中,当前吸烟者和既往吸烟者之间的疗效是否存在差异。本研究旨在探讨 LABA/LAMA 治疗方案在这两组人群中的有效性。

方法

TOReTO 试验评估了肺功能、症状、健康状况、加重事件的发生、有临床意义的加重事件以及 LABA/LAMA 治疗的使用情况。这些治疗方法包括 Tio/Olo、乌美溴铵/维兰特罗(Umec/Vi)和乌美溴铵/维兰特罗(Umec/Vi),用于 COPD 患者。研究考察了当前吸烟者和既往吸烟者在结局上的差异。为了平衡基线特征,采用了倾向评分匹配(PSM)。

结果

共纳入 967 例患者的数据。在 PSM 后,分别分析了当前吸烟者三组治疗方案中首次急性加重的时间,且组间差异有统计学意义(p=0.0457)。在 Umec/Vi 中,治疗和吸烟状态之间的急性加重发生率存在差异(p=0.0114)。在 LABA/LAMA 固定剂量组合的三组中,既往吸烟者的治疗效果没有显著差异(p=0.3079)。整个治疗期间,COPD 相关症状保持稳定。研究结束时,三组的症状评分(CAT 和 mMRC)均无显著差异。

结论

三种 LABA/LAMA 固定剂量组合在减少既往吸烟者的加重方面没有差异,但在当前吸烟者中存在差异。这一趋势具有临床意义,未来将进行控制影响变量的研究来验证这一点。然而,由于研究设计是非随机的,这些发现应谨慎解释。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb3a/11487693/70eee01acf8c/12931_2024_2971_Fig1_HTML.jpg

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