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通过临床慢性阻塞性肺疾病问卷评分的改善来衡量噻托溴铵/奥达特罗联合治疗慢性阻塞性肺疾病(COPD)在波兰标准临床实践中的有效性:一项观察性研究。

Effectiveness of chronic obstructive pulmonary disease (COPD) treatment with a combination of tiotropium / olodaterol in Polish standard clinical practice as measured by the improvement of the Clinical COPD Questionnaire score: an observational study.

作者信息

Kania Aleksander, Celejewska-Wójcik Natalia, Żurowska Katarzyna, Barczyk Adam

机构信息

Department of Pulmonology, Second Department of Internal Medicine, Faculty of Medicine, Jagiellonian University Medical College, Kraków, Poland.

Department of Pulmonology, Second Department of Internal Medicine, Faculty of Medicine, Jagiellonian University Medical College, Kraków, Poland

出版信息

Pol Arch Intern Med. 2022 Aug 22;132(7-8). doi: 10.20452/pamw.16268. Epub 2022 May 27.

DOI:10.20452/pamw.16268
PMID:35635728
Abstract

INTRODUCTION

Health‑related quality of life in patients with chronic obstructive pulmonary disease (COPD) can be measured by the Clinical COPD Questionnaire (CCQ). In this study, the CCQ was used to assess the therapeutic success of a fixed‑dose tiotropium / olodaterol combination treatment in Polish COPD patients.

OBJECTIVES

We aimed to evaluate the changes in the CCQ score in Polish patients with COPD after 6 weeks of treatment with tiotropium / olodaterol and to assess the predictors of response to this treatment.

PATIENTS AND METHODS

Data of the Polish subgroup of the NIS‑CCQ observational study (NCT03663569) were extracted. COPD patients who had received a new tiotropium / olodaterol prescription were included. The primary end point was therapeutic success predefined as a 0.4‑point reduction in the CCQ score after 6 weeks of tiotropium / olodaterol treatment. Post‑hoc logistic regression analysis was performed to identify the predictors of response to the treatment.

RESULTS

After 6 weeks of treatment, 72.4% of patients achieved therapeutic success. The therapy was successful in 83.4% of treatment‑naïve patients, as compared with 62.6% and 73.3% of those previously treated with long‑acting muscarinic antagonists or long‑acting β2 agonists in monotherapy and in combination with inhaled corticosteroids, respectively. Therapeutic success was achieved by at least 50% of patients regardless of the COPD severity and exacerbation history but it was more frequent in patients with more severe disease. The airflow limitation severity grades 2 to 4, modified Medical Research Council Dyspnea Scale classes 2 to 4, exacerbations within the last year before the study, and treatment‑naïve status predicted a better response to tiotropium / olodaterol.

CONCLUSIONS

Tiotropium / olodaterol treatment improved clinical control in Polish COPD patients. Therapeutic success was the most pronounced in individuals with more severe COPD and in the treatment‑naïve group but occurred also in those with moderate disease and in previously treated participants.

摘要

引言

慢性阻塞性肺疾病(COPD)患者的健康相关生活质量可用慢性阻塞性肺疾病临床问卷(CCQ)进行测量。在本研究中,CCQ用于评估波兰COPD患者使用噻托溴铵/奥达特罗固定剂量联合治疗的疗效。

目的

我们旨在评估波兰COPD患者接受噻托溴铵/奥达特罗治疗6周后CCQ评分的变化,并评估该治疗反应的预测因素。

患者与方法

提取NIS-CCQ观察性研究(NCT03663569)波兰亚组的数据。纳入接受新的噻托溴铵/奥达特罗处方的COPD患者。主要终点是治疗成功,定义为噻托溴铵/奥达特罗治疗6周后CCQ评分降低0.4分。进行事后逻辑回归分析以确定治疗反应的预测因素。

结果

治疗6周后,72.4%的患者获得治疗成功。在初治患者中,治疗成功率为83.4%,而之前分别接受长效毒蕈碱拮抗剂单药治疗或与吸入性糖皮质激素联合使用长效β2激动剂治疗的患者,治疗成功率分别为62.6%和73.3%。无论COPD严重程度和加重病史如何,至少50%的患者获得了治疗成功,但在病情更严重的患者中更为常见。气流受限严重程度为2至4级、改良的医学研究委员会呼吸困难量表分级为2至4级、研究前最后一年内的加重情况以及初治状态可预测对噻托溴铵/奥达特罗的反应更好。

结论

噻托溴铵/奥达特罗治疗改善了波兰COPD患者的临床控制。治疗成功在COPD更严重的个体和初治组中最为显著,但在中度疾病患者和先前接受过治疗的参与者中也有发生。

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