相対作用素エントロピーをめぐって(作用素不等式とその周辺)

Independent Ethics Committees and Institutional Review Boards for ClinicalTrial.gov: NCT01072396. (PDF 71 kb

Proportion of controls subjects and patients with GOLD grade 1 COPD within each cluster.

<p>Proportion of controls subjects and patients with GOLD grade 1 COPD within each cluster.</p

Cluster Analysis in Patients with GOLD 1 Chronic Obstructive Pulmonary Disease

<div><p>Background</p><p>We hypothesized that heterogeneity exists within the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 1 spirometric category and that different subgroups could be identified within this GOLD category.</p><p>Methods</p><p>Pre-randomization study participants from two clinical trials were symptomatic/asymptomatic GOLD 1 chronic obstructive pulmonary disease (COPD) patients and healthy controls. A hierarchical cluster analysis used pre-randomization demographics, symptom scores, lung function, peak exercise response and daily physical activity levels to derive population subgroups.</p><p>Results</p><p>Considerable heterogeneity existed for clinical variables among patients with GOLD 1 COPD. All parameters, except forced expiratory volume in 1 second (FEV₁)/forced vital capacity (FVC), had considerable overlap between GOLD 1 COPD and controls. Three-clusters were identified: cluster I (18 [15%] COPD patients; 105 [85%] controls); cluster II (45 [80%] COPD patients; 11 [20%] controls); and cluster III (22 [92%] COPD patients; 2 [8%] controls). Apart from reduced diffusion capacity and lower baseline dyspnea index versus controls, cluster I COPD patients had otherwise preserved lung volumes, exercise capacity and physical activity levels. Cluster II COPD patients had a higher smoking history and greater hyperinflation versus cluster I COPD patients. Cluster III COPD patients had reduced physical activity versus controls and clusters I and II COPD patients, and lower FEV₁/FVC versus clusters I and II COPD patients.</p><p>Conclusions</p><p>The results emphasize heterogeneity within GOLD 1 COPD, supporting an individualized therapeutic approach to patients.</p><p>Trial registration</p><p>www.clinicaltrials.gov. <a href="https://clinicaltrials.gov/ct2/show/NCT01360788" target="_blank">NCT01360788</a> and <a href="https://clinicaltrials.gov/ct2/show/NCT01072396" target="_blank">NCT01072396</a>.</p></div

V′o_{2 peak} relative to body weight and daily physical activity levels by cluster.

<p>a) Peak oxygen consumption (V′o_{2 peak}) relative to body weight; b) mean steps per day; c) mean daily energy expenditure (EE); d) mean daily time >3 metabolic equivalents (METs); and e) baseline dyspnea index (BDI) score by cluster of patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade 1 chronic obstructive pulmonary disease. Values are mean ± SD. Dashed lines represent mean values in control subjects. *p<0.01 versus controls subjects; ^†p<0.05 versus cluster I and II.</p

Frequency distributions for pulmonary function, peak V′o₂, BDI score and physical activity.

<p>a) forced expiratory volume in 1 second (FEV₁); b) FEV₁/forced vital capacity (FVC) ratio; c) total lung capacity (TLC); d) functional residual capacity (FRC); e) residual volume (RV); f) diffusion capacity (<i>D</i>lco); g) peak oxygen uptake (V′o₂ peak); h) baseline dyspnea index (BDI) score; i) number of steps per day; j) and daily time spent in physical activity >3 metabolic equivalents (METs). GOLD: Global Initiative for Chronic Obstructive Lung Disease.</p

Pulmonary function parameters expressed as percentage of predicted values by cluster.

<p>a) forced expiratory volume in 1 second (FEV₁); b) total lung capacity (TLC); c) functional residual volume (FRC); d) residual volume (RV); and e) diffusion capacity (<i>D</i>lco); as well as f) FEV₁/forced vital capacity (FVC) ratio by cluster of patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade 1 chronic obstructive pulmonary disease. Values are mean ± SD. Dashed lines represent mean values in control subjects. *p<0.01 versus healthy controls; ^†p<0.05 versus cluster I; ^‡p<0.01 versus cluster I and II.</p

Breathing pattern and operating lung volume measurements versus work rate during incremental treadmill exercise.

<p>(A) Breathing frequency (<i>F</i>b), (B) tidal volume, (C) inspiratory capacity (IC), and (D) inspiratory reserve volume (IRV) showing that all three groups reach a similar minimal value at end-exercise (shaded area). Data are shown as mean ± standard error. TLC, total lung capacity. *p<0.05 GOLD 1 and 2 versus controls at a standardized work rate; ^#p<0.05 GOLD 1 versus controls; ^†p<0.05 GOLD 2 versus GOLD 1 and controls (confidence intervals do not overlap indicating p<0.05).</p

Pulmonary function.

<p>Data are presented as mean ± standard deviation.</p><p>GOLD, Global Initiative for Chronic Obstructive Lung Disease; FEV₁, forced expiratory volume in 1 s; FVC, forced vital capacity; SVC, slow vital capacity; IC, inspiratory capacity; FRC, functional residual capacity; RV, residual volume; TLC, total lung capacity; sR_aw, specific airway resistance; DL_CO, diffusing capacity of the lung for carbon monoxide.</p><p>P-values are from a linear regression model, adjusted for age, sex, alcohol status, employment status, and body mass index.</p><p>**p<0.01 versus control;</p><p>***p<0.001 versus control.</p>#<p>p<0.05 GOLD 1 versus GOLD 2;</p>###<p>p<0.001 GOLD 1 versus GOLD 2.</p>†<p>GOLD 1, n = 40; GOLD 2, n = 62.</p>‡<p>GOLD 2, n = 61.</p

Intensity ratings of (A) dyspnea and (B) leg discomfort versus work rate during incremental treadmill exercise.

<p>Data are shown as mean ± standard error. *p<0.05 GOLD 1 and GOLD 2 versus controls at a standardized work rate; ^#p<0.05 GOLD 1 versus controls (confidence intervals do not overlap indicating p<0.05).</p

Peak symptom-limited incremental treadmill exercise.

<p>Data are presented as mean ± standard deviation.</p><p>GOLD, Global Initiative for Chronic Obstructive Lung Disease; , oxygen uptake; , carbon dioxide production; , minute ventilation; MBC, maximum breathing capacity; Vt, tidal volume; <i>F</i>b, breathing frequency; Ti, inspiratory time; Ttot, total respiratory time; Ti_/Ttot, inspiratory duty cycle; IC, inspiratory capacity; Δ, change; IRV, inspiratory reserve volume; EELV, end-expiratory lung volumes; SpO₂, arterial oxygen saturation measured by pulse oximetry.</p><p>P-values are from a linear regression model, adjusted for age, sex, alcohol status, employment status, and body mass index.</p><p>*p<0.05 versus control;</p><p>**p<0.01 versus control;</p><p>***p<0.001 versus control</p>#<p>p<0.05 GOLD 1 versus GOLD 2;</p>##<p>p<0.01 GOLD 1 versus GOLD 2;</p>###<p>p<0.001 GOLD 1 versus GOLD 2.</p>†<p>GOLD 2, n = 62.</p