A Randomized Trial of Long-Term Oxygen for COPD with Moderate Desaturation

被引:304
作者
Albert, Richard K. [1 ]
Au, David H. [2 ,3 ]
Blackford, Amanda L. [4 ]
Casaburi, Richard [4 ,6 ]
Cooper, J. Allen, Jr. [8 ,9 ]
Criner, Gerard J. [10 ]
Diaz, Philip [12 ]
Fuhlbrigge, Anne L. [16 ,17 ]
Gay, Steven E. [18 ]
Kanner, Richard E. [19 ]
MacIntyre, Neil [20 ]
Martinez, Fernando J. [21 ]
Panos, Ralph J. [13 ,14 ]
Piantadosi, Steven [7 ]
Sciurba, Frank [11 ]
Shade, David [5 ]
Stibolt, Thomas [22 ]
Stoller, James K. [15 ]
Wise, Robert
Yusen, Roger D. [23 ]
Tonascia, James [5 ]
Sternberg, Alice L. [5 ]
Bailey, William [9 ]
机构
[1] Univ Colorado, Denver, CO 80202 USA
[2] Vet Affairs VA Puget Sound Hlth Care Syst, Seattle, WA USA
[3] Univ Washington, Seattle, WA 98195 USA
[4] Johns Hopkins Univ, Sch Med, Baltimore, MD USA
[5] Johns Hopkins Univ, Bloomberg Sch Publ Hlth, Baltimore, MD USA
[6] Harbor UCLA Med Ctr, Los Angeles Biomed Res Inst, Los Angeles, CA USA
[7] Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA
[8] Birmingham VA Med Ctr, Birmingham, AL USA
[9] Univ Alabama Birmingham, Birmingham, AL USA
[10] Temple Univ, Lewis Katz Sch Med, Philadelphia, PA 19122 USA
[11] Univ Pittsburgh, Pittsburgh, PA USA
[12] Ohio State Univ, Columbus, OH 43210 USA
[13] Cincinnati VA Med Ctr, Cincinnati, OH USA
[14] Univ Cincinnati, Coll Med, Cincinnati, OH USA
[15] Cleveland Clin, Cleveland, OH 44106 USA
[16] Brigham & Womens Hosp, 75 Francis St, Boston, MA 02115 USA
[17] Harvard Med Sch, Boston, MA USA
[18] Univ Michigan, Ann Arbor, MI 48109 USA
[19] Univ Utah, Hlth Sci Ctr, Salt Lake City, UT USA
[20] Duke Univ, Med Ctr, Durham, NC USA
[21] Weill Cornell Med Ctr, New York, NY USA
[22] Kaiser Permanente, Ctr Hlth Res, Portland, OR USA
[23] Washington Univ, Sch Med, St Louis, MO 63130 USA
关键词
OBSTRUCTIVE PULMONARY-DISEASE; EXERCISE; THERAPY; SCALE; VALIDITY; QUALITY; DYSPNEA; INDEX;
D O I
10.1056/NEJMoa1604344
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND Long-term treatment with supplemental oxygen has unknown efficacy in patients with stable chronic obstructive pulmonary disease (COPD) and resting or exercise-induced moderate desaturation. METHODS We originally designed the trial to test whether long-term treatment with supplemental oxygen would result in a longer time to death than no use of supplemental oxygen among patients who had stable COPD with moderate resting desaturation (oxyhemoglobin saturation as measured by pulse oximetry [Spo(2)], 89 to 93%). After 7 months and the randomization of 34 patients, the trial was redesigned to also include patients who had stable COPD with moderate exercise-induced desaturation (during the 6-minute walk test, Spo(2) >= 80% for >= 5 minutes and < 90% for >= 10 seconds) and to incorporate the time to the first hospitalization for any cause into the new composite primary outcome. Patients were randomly assigned, in a 1: 1 ratio, to receive long-term supplemental oxygen (supplemental-oxygen group) or no long-term supplemental oxygen (no-supplemental-oxygen group). In the supplemental-oxygen group, patients with resting desaturation were prescribed 24-hour oxygen, and those with desaturation only during exercise were prescribed oxygen during exercise and sleep. The trial-group assignment was not masked. RESULTS A total of 738 patients at 42 centers were followed for 1 to 6 years. In a time-to-event analysis, we found no significant difference between the supplemental-oxygen group and the no-supplemental-oxygen group in the time to death or first hospitalization (hazard ratio, 0.94; 95% confidence interval [CI], 0.79 to 1.12; P = 0.52), nor in the rates of all hospitalizations (rate ratio, 1.01; 95% CI, 0.91 to 1.13), COPD exacerbations (rate ratio, 1.08; 95% CI, 0.98 to 1.19), and COPD-related hospitalizations (rate ratio, 0.99; 95% CI, 0.83 to 1.17). We found no consistent between-group differences in measures of quality of life, lung function, and the distance walked in 6 minutes. CONCLUSIONS In patients with stable COPD and resting or exercise-induced moderate desaturation, the prescription of long-term supplemental oxygen did not result in a longer time to death or first hospitalization than no long-term supplemental oxygen, nor did it provide sustained benefit with regard to any of the other measured outcomes. (Funded by the National Heart, Lung, and Blood Institute and the Centers for Medicare and Medicaid Services; LOTT ClinicalTrials.gov number, NCT00692198.)
引用
收藏
页码:1617 / 1627
页数:11
相关论文
共 29 条
[1]  
Ameer F, 2014, COCHRANE DATABASE SY, V6
[2]  
[Anonymous], 1980, ANN INTERN MED, V93, P391
[3]  
[Anonymous], 2013, 2013 CMS STAT CMS PU, V03504
[4]  
[Anonymous], 1996, MULTIPLE COMP THEORY, DOI DOI 10.1201/B15074
[5]   American translation, modification, and validation of the St. George's Respiratory Questionnaire [J].
Barr, JT ;
Schumacher, GE ;
Freeman, S ;
LeMoine, M ;
Bakst, AW ;
Jones, PW .
CLINICAL THERAPEUTICS, 2000, 22 (09) :1121-1145
[6]   The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease [J].
Celli, BR ;
Cote, CG ;
Marin, JM ;
Casanova, C ;
de Oca, MM ;
Mendez, RA ;
Pinto Plata, V ;
Cabral, HJ .
NEW ENGLAND JOURNAL OF MEDICINE, 2004, 350 (10) :1005-1012
[7]   A randomized trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease patients [J].
Chaouat, A ;
Weitzenblum, E ;
Kessler, R ;
Charpentier, C ;
Ehrhart, M ;
Schott, R ;
Levi-Valensi, P ;
Zielinski, J ;
Delaunois, L ;
Cornudella, R ;
dos Santos, JM .
EUROPEAN RESPIRATORY JOURNAL, 1999, 14 (05) :1002-1008
[8]  
COX DR, 1972, J R STAT SOC B, V34, P187
[9]   Continuous oxygen use in nonhypoxemic emphysema patients identifies a high-risk subset of patients - Retrospective analysis of the National Emphysema Treatment Trial [J].
Drummond, Michael B. ;
Blackford, Amanda L. ;
Benditt, Joshua O. ;
Make, Barry J. ;
Sciurba, Frank C. ;
McCormack, Meredith C. ;
Martinez, Fernando J. ;
Fessler, Henry E. ;
Fishman, Alfred P. ;
Wise, Robert A. .
CHEST, 2008, 134 (03) :497-506
[10]   Benefits of supplemental oxygen in exercise training in nonhypoxemic chronic obstructive pulmonary disease patients [J].
Emtner, M ;
Porszasz, J ;
Burns, M ;
Somfay, A ;
Casaburi, R .
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 2003, 168 (09) :1034-1042