提示: 手机请竖屏浏览!

长期吸氧治疗伴中度减饱和的COPD的随机试验
A Randomized Trial of Long-Term Oxygen for COPD with Moderate Desaturation


The Long-Term Oxygen Treatment Trial Research Group* 呼吸系统疾病 • 2016.10.27
相关阅读
• COPD加重患者何时适用无创通气 • 阿奇霉素用于预防COPD的加重研究 • 临床实践中糠酸氟替卡松-维兰特罗对COPD治疗的有效性 • COPD患者第一秒用力呼气量随时间的变化


中度缺氧的慢性阻塞性肺疾病患者是否需要长期氧疗

 

牟密†,何建‡,徐国纲†*

† 中国人民解放军总医院南楼呼吸科;‡ 陆军医科大学附属西南医院呼吸科

* 通讯作者

 

慢性阻塞性肺疾病(chronic obstructive lung disease,COPD)是全球常见慢性疾病之一。据估计,2010年COPD全球发病率为11.7%1。由于吸烟、空气污染、老龄化等原因,COPD在全球的发病率仍然有上升趋势。中国存在COPD诊断、管理以及认知不足等情况,据中国2007年的一项调查研究2,所有被诊断为COPD的患者中,既往仅有35.1%的患者曾被确诊为COPD。提高COPD的诊断率,积极有效地进行COPD稳定期管理,包括戒烟、疫苗接种、康复治疗、药物治疗、氧疗等措施,能够改善患者的症状,降低未来发生不良事件的风险。

查看更多

摘要


背景

对于伴有静息或运动诱发中度减饱和的稳定型慢性阻塞性肺疾病(COPD)患者而言,我们尚不知晓长期供氧治疗的疗效。

 

方法

研究者最初的试验设计是在伴有中度静息减饱和(血氧饱和度通过脉搏血氧测定[SpO2],89%~93%)的稳定型COPD患者中,测试长期补氧治疗与不使用补氧治疗相比,能否延长患者的生存期。试验进行7个月后,共随机分配了34例患者,随后研究者对试验进行了重新设计,新试验同时纳入了伴有运动诱发中度减饱和的稳定型COPD患者(在6分钟步行试验期间,≥5分钟时SpO2≥80%,≥10秒时SpO2<90%),并将因任何原因引起的首次住院前时间纳入新的复合主要结局。以1∶1的比例,将患者随机分配至接受长期补氧组(辅助供氧组)或不接受长期补氧组(无补氧组)。在补氧组,静息减饱和患者将接受24小时氧疗,而仅在运动期间出现减饱和的患者将在运动和睡眠期间接受氧疗。试验组分配并未采用盲法。

 

结果

本研究在42个中心招募了738例患者,随访1~6年。在至事件时间分析中,研究者发现补氧组与无补氧组之间在生存期或首次住院前时间(风险比[HR],0.94;95%置信区间[CI],0.79~1.12;P=0.52)、所有住院治疗率(RR=1.01;95% CI,0.91~1.13)、COPD加重(RR=1.08;95% CI,0.98~1.19)以及COPD相关住院治疗率(RR=0.99;95% CI,0.83~1.17)中均未见显著差异。研究者在生活质量、肺功能以及6分钟步行距离中也未见一致的组间差异。

 

结论

在伴有静息或运动诱发中度减饱和的稳定型COPD患者中,长期补氧治疗并未延长患者的生存期或至首次住院治疗的时间,同时对于其他测试结局,也未提供持久的益处(该研究由美国国立心肺血液研究所[National Heart, Lung, and Blood Institute]和老年医疗保险和医疗补助服务中心[Centers for Medicare and Medicaid Services]等资助;LOTT在ClinicalTrials.gov注册号为NCT00692198)。





作者信息

The Long-Term Oxygen Treatment Trial Research Group*
The members of the writing committee (Richard K. Albert, M.D., David H. Au, M.D., Amanda L. Blackford, Sc.M., Richard Casaburi, M.D., Ph.D., J. Allen Cooper, Jr., M.D., Gerard J. Criner, M.D., Philip Diaz, M.D., Anne L. Fuhlbrigge, M.D., Steven E. Gay, M.D., Richard E. Kanner, M.D., Neil MacIntyre, M.D., Fernando J. Martinez, M.D., Ralph J. Panos, M.D., Steven Piantadosi, M.D., Ph.D., Frank Sciurba, M.D., David Shade, J.D., Thomas Stibolt, M.D., James K. Stoller, M.D., Robert Wise, M.D., Roger D. Yusen, M.D., James Tonascia, Ph.D., Alice L. Sternberg, Sc.M., and William Bailey, M.D.) assume responsibility for this article. The affiliations of the members of the writing committee are listed in the Appendix. Address reprint requests to Dr. Wise at the Johns Hopkins Asthma and Allergy Center, 4B.72, Division of Pulmonary and Critical Care, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, or at rwise@jhmi.edu. *A complete list of investigators in the Long-Term Oxygen Treatment Trial (LOTT) Research Group is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

1.Nocturnal Oxygen Therapy Trial Group. Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Ann Intern Med 1980;93:391-398

2.Medical Research Council Working Party. Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema: report of the Medical Research Council Working Party Lancet 1981;1:681-686

3.Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med 2011;155:179-191

4.Vestbo J, Hurd SS, Agustí AG, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med 2013;187:347-365

5.Chaouat A, Weitzenblum E, Kessler R, et al. A randomized trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease patients. Eur Respir J 1999;14:1002-1008

6.Górecka D, Gorzelak K, Sliwiński P, Tobiasz M, Zieliński J. Effect of long-term oxygen therapy on survival in patients with chronic obstructive pulmonary disease with moderate hypoxaemia. Thorax 1997;52:674-679

7.O’Donnell DE, D’Arsigny C, Webb KA. Effects of hyperoxia on ventilatory limitation during exercise in advanced chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2001;163:892-898

8.Ringbaek T, Martinez G, Lange P. The long-term effect of ambulatory oxygen in normoxaemic COPD patients: a randomised study. Chron Respir Dis 2013;10:77-84

9.Emtner M, Porszasz J, Burns M, Somfay A, Casaburi R. Benefits of supplemental oxygen in exercise training in nonhypoxemic chronic obstructive pulmonary disease patients. Am J Respir Crit Care Med 2003;168:1034-1042

10.Stoller JK, Panos RJ, Krachman S, Doherty DE, Make B. Oxygen therapy for patients with COPD: current evidence and the Long-term Oxygen Treatment Trial. Chest 2010;138:179-187

11.2013 CMS statistics: CMS publication 03504. Washington, DC: Office of Information Products and Data Analytics, August 2013.

12.Drummond MB, Blackford AL, Benditt JO, et al. Continuous oxygen use in nonhypoxemic emphysema patients identifies a high-risk subset of patients: retrospective analysis of the National Emphysema Treatment Trial. Chest 2008;134:497-506

13.Kaplan RM, Atkins CJ, Timms R. Validity of a quality of well-being scale as an outcome measure in chronic obstructive pulmonary disease. J Chronic Dis 1984;37:85-95

14.Kaplan RM. The minimally clinically important difference in generic utility-based measures. COPD 2005;2:91-97

15.Barr JT, Schumacher GE, Freeman S, LeMoine M, Bakst AW, Jones PW. American translation, modification, and validation of the St. George’s Respiratory Questionnaire. Clin Ther 2000;22:1121-1145

16.Jones PW. St. George’s Respiratory Questionnaire: MCID. COPD 2005;2:75-79

17.Ware JE Jr, Kosinski M, Bayliss MS, McHorney CA, Rogers WH, Raczek A. Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. Med Care 1995;33:AS264-79

18.Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand 1983;67:361-370

19.Puhan MA, Frey M, Büchi S, Schünemann HJ. The minimal important difference of the Hospital Anxiety and Depression Scale in patients with chronic obstructive pulmonary disease. Health Qual Life Outcomes 2008;6:46-46

20.Spira AP, Beaudreau SA, Stone KL, et al. Reliability and validity of the Pittsburgh Sleep Quality Index and the Epworth Sleepiness Scale in older men. J Gerontol A Biol Sci Med Sci 2012;67:433-439

21.Cox DR. Regression models and life-tables. J R Stat Soc [B] 1972;34:187-220

22.Hsu JC. Multiple comparisons: theory and methods. London: Chapman and Hall, 1996.

23.Celli BR, Cote CG, Marin JM, et al. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med 2004;350:1005-1012

24.Ameer F, Carson KV, Usmani ZA, Smith BJ. Ambulatory oxygen for people with chronic obstructive pulmonary disease who are not hypoxaemic at rest. Cochrane Database Syst Rev 2014:CD000238-CD000238

25.Timms RM, Tisi GM. The effect of short-term oxygen supplementation on oxygen hemoglobin affinity in patients with chronic obstructive pulmonary disease. Am Rev Respir Dis 1985;131:69-72

26.Williamson W, Fuld J, Westgate K, Sylvester K, Ekelund U, Brage S. Validity of reporting oxygen uptake efficiency slope from submaximal exercise using respiratory exchange ratio as secondary criterion. Pulm Med 2012;2012:874020-874020

27.Uronis HE, Ekström MP, Currow DC, McCrory DC, Samsa GP, Abernethy AP. Oxygen for relief of dyspnoea in people with chronic obstructive pulmonary disease who would not qualify for home oxygen: a systematic review and meta-analysis. Thorax 2015;70:492-494

28.Fletcher EC, Luckett RA, Miller T, Fletcher JG. Exercise hemodynamics and gas exchange in patients with chronic obstruction pulmonary disease, sleep desaturation, and a daytime PaO2 above 60 mm Hg. Am Rev Respir Dis 1989;140:1237-1245

29.Fletcher EC, Miller J, Divine GW, Fletcher JG, Miller T. Nocturnal oxyhemoglobin desaturation in COPD patients with arterial oxygen tensions above 60 mm Hg. Chest 1987;92:604-608

服务条款 | 隐私政策 | 联系我们