噻托溴铵/奥达特罗一线治疗可改善初治慢性阻塞性肺疾病患者的身体活动能力。
First-Line Treatment with Tiotropium/Olodaterol Improves Physical Activity in Patients with Treatment-Naïve Chronic Obstructive Pulmonary Disease.
作者信息
Takahashi Koichiro, Uchida Masaru, Kato Go, Takamori Ayako, Kinoshita Takashi, Yoshida Makoto, Tajiri Ryo, Kojima Keisuke, Inoue Hiroshi, Kobayashi Hiromi, Sadamatsu Hironori, Tashiro Hiroki, Tanaka Masahide, Hayashi Shinichiro, Kawaguchi Atsushi, Kimura Shinya, Sueoka-Aragane Naoko, Kawayama Tomotaka
机构信息
Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.
Division of Internal Medicine, Japan Community Health Care Organization Saga Central Hospital, Saga, Japan.
出版信息
Int J Chron Obstruct Pulmon Dis. 2020 Sep 14;15:2115-2126. doi: 10.2147/COPD.S268905. eCollection 2020.
BACKGROUND
Comparative effects on physical activity of mono and dual bronchodilators remain unclear in patients with treatment-naïve chronic obstructive pulmonary disease (COPD). We sought to compare the changes in physical activity before and after tiotropium and tiotropium/olodaterol treatment in treatment-naïve COPD patients.
METHODS
A prospective, multicenter, randomized, open-labeled, and parallel interventional study was conducted. Eighty Japanese patients with treatment-naïve COPD were randomized to receive either tiotropium or tiotropium/olodaterol treatment for 12 weeks. Spirometry and dyspnea index were assessed, and COPD assessment test (CAT) and the 6-minute walk distance (6MWD) were conducted before and after treatment. Evaluation of physical activity was assessed by a triaxle accelerometer over a 2-week period before and after treatment.
RESULTS
There were no differences in the mean age (69.8 vs 70.4 years), body mass index (BMI) (22.5 vs 22.6 kg/m) and mean % forced expiratory volume in 1 second (%FEV1) at baseline (61.5 vs 62.6%) between the two groups. Changes in FEV1 (mean±standard error, 242.8±28.8 mL) and transient dyspnea index (TDI) (2.4±0.3 points) before and after tiotropium/olodaterol treatment were greater than with tiotropium treatment (104.1±31.9 mL, p<0.01 and 1.5±0.3, p=0.02, respectively). Changes in the duration of physical activity with 1.0-1.5 metabolic equivalents (METs) estimated in the sedentary position following tiotropium/olodaterol treatment (-38.7±14.7 min) tended to be reduced more than with tiotropium treatment (-4.6±10.6 min) (p=0.06), although those with ≥2.0 METs numerically increased with both treatments (+10.8±7.6 min for tiotropium/olodaterol vs +8.3±7.6 min for tiotropium, p=0.82). Tiotropium/olodaterol treatment reduced the duration of physical activity with 1.0-1.5 METs (regression coefficient, -43.6 [95% CI -84.1, -3.1], p=0.04) in a multiple regression model adjusted for cofounding factors such as age, FEV1, total CAT scores, 6MWD, and TDI.
CONCLUSION
This is the first study to report the impact of dual bronchodilator on physical activity in treatment-naïve COPD patients of Japanese with low BMI.
背景
在初治慢性阻塞性肺疾病（COPD）患者中，单支气管扩张剂和双支气管扩张剂对身体活动的比较效果仍不清楚。我们试图比较初治COPD患者使用噻托溴铵和噻托溴铵/奥达特罗治疗前后身体活动的变化。
方法
进行了一项前瞻性、多中心、随机、开放标签和平行干预研究。80例初治COPD日本患者被随机分为接受噻托溴铵或噻托溴铵/奥达特罗治疗12周。评估肺功能和呼吸困难指数，并在治疗前后进行COPD评估测试（CAT）和6分钟步行距离（6MWD）。通过三轴加速度计在治疗前后的2周内评估身体活动。
结果
两组在基线时的平均年龄（69.8岁对70.4岁）、体重指数（BMI）（22.5对22.6kg/m）和平均第1秒用力呼气容积百分比（%FEV1）（61.5%对62.6%）无差异。噻托溴铵/奥达特罗治疗前后FEV1的变化（平均值±标准误差，242.8±28.8mL）和短暂呼吸困难指数（TDI）（2.4±0.3分）大于噻托溴铵治疗（104.1±31.9mL，p<0.01；1.5±0.3，p=0.02）。噻托溴铵/奥达特罗治疗后，久坐状态下估计的1.0-1.5代谢当量（METs）身体活动持续时间的变化（-38.7±14.7分钟）比噻托溴铵治疗（-4.6±10.6分钟）更倾向于减少（p=0.06），尽管两种治疗下≥2.0METs的身体活动持续时间在数值上均增加（噻托溴铵/奥达特罗为+10.8±7.6分钟，噻托溴铵为+8.3±7.6分钟，p=0.82）。在针对年龄、FEV1、总CAT评分、6MWD和TDI等混杂因素进行调整的多元回归模型中，噻托溴铵/奥达特罗治疗减少了1.0-1.5METs身体活动的持续时间（回归系数，-43.6[95%CI-84.1，-3.1]，p=0.04）。
结论
这是第一项报告双支气管扩张剂对低BMI日本初治COPD患者身体活动影响的研究。
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