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中国人群中慢性阻塞性肺疾病(COPD)三联吸入疗法从多种吸入装置转换为单一吸入装置的前瞻性随机研究。

Prospective Randomized Study on Switching Triple Inhaler Therapy in COPD from Multiple Inhaler Devices to a Single Inhaler Device in a Chinese Population.

作者信息

Kwok Wang Chun, Ma Ting Fung, Tsui Chung Ki, Ho James Chung Man, Tam Terence Chi Chun

机构信息

Department of Medicine, Queen Mary Hospital, University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China.

Department of Statistics, College of Arts and Sciences, University of South Carolina, Columbia, South Carolina, United States.

出版信息

Chronic Obstr Pulm Dis. 2025 Jan 29;12(1):52-60. doi: 10.15326/jcopdf.2024.0519.

Abstract

BACKGROUND

Triple therapy with inhaled corticosteroids and dual bronchodilator therapy is recommended for chronic obstructive pulmonary disease (COPD) patients who have exacerbations and eosinophilia. It can be administered by single inhaler triple therapy (SITT) or by multiple inhaler triple therapy (MITT). There is a lack of evidence of the benefits of SITT over MITT in the Chinese population, especially on switching from existing MITT to SITT.

METHODS

A total of 70 Chinese patients with COPD were recruited in this open-label, double-arm clinical trial to investigate the number of critical inhaler errors, the modified Medical Research Council (mMRC) dyspnea scale, the Medication Adherence Report Scale for Asthma (MARS-A) score, and a satisfaction score upon switching from MITT to SITT.

RESULTS

The mean number of critical inhaler errors was 0.4±1.0 in the SITT group and 1.1±1.8 in the MITT group( =0.038) at the first visit; and 0.2±0.6 in the SITT group and 0.8±1.1 in the MITT group (=0.007) at the second visit. The mean change in MARS-A from baseline to first visit was +3.76±7.48 in the SITT group and -1.27±7.76 in the MITT group (-value 0.008). A total of 22 (59.5%) and 8 (24.2%) of the patients in the SITT and the MITT group respectively, had an increase in MARS-A score from baseline to first visit, with an adjusted odds ratio of 6.23 (95% confidence interval=1.63-23.77, =0.007), favoring SITT. There was no significant difference in the change in the mMRC dyspnea scale and the satisfaction score between the 2 groups.

CONCLUSION

Switching from MITT to SITT in Chinese COPD patients may have the benefits of having fewer critical inhaler errors and a higher MARS-A score.

摘要

背景

对于有急性加重和嗜酸性粒细胞增多的慢性阻塞性肺疾病(COPD)患者,推荐吸入糖皮质激素与双重支气管扩张剂联合治疗。可通过单吸入器三联疗法(SITT)或多吸入器三联疗法(MITT)给药。在中国人群中,缺乏SITT优于MITT的获益证据,尤其是从现有的MITT转换为SITT时。

方法

在这项开放标签、双臂临床试验中,共招募了70名中国COPD患者,以调查严重吸入错误的数量、改良医学研究委员会(mMRC)呼吸困难量表、哮喘药物依从性报告量表(MARS-A)评分以及从MITT转换为SITT后的满意度评分。

结果

首次就诊时,SITT组严重吸入错误的平均数量为0.4±1.0,MITT组为1.1±1.8(P=0.038);第二次就诊时,SITT组为0.2±0.6,MITT组为0.8±1.1(P=0.007)。从基线到首次就诊,SITT组MARS-A的平均变化为+3.76±7.48,MITT组为-1.27±7.76(P值0.008)。SITT组和MITT组分别有22名(59.5%)和8名(24.2%)患者从基线到首次就诊时MARS-A评分增加,调整后的优势比为6.23(95%置信区间=1.63-23.77,P=0.007),支持SITT。两组之间mMRC呼吸困难量表的变化和满意度评分无显著差异。

结论

中国COPD患者从MITT转换为SITT可能有减少严重吸入错误和提高MARS-A评分的益处。

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2
Clinical Concepts for Triple Therapy Use in Patients with COPD: A Delphi Consensus.用于 COPD 患者三联疗法的临床概念:德尔菲共识。
Int J Chron Obstruct Pulmon Dis. 2023 Aug 28;18:1853-1866. doi: 10.2147/COPD.S424128. eCollection 2023.

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