补充氧气对许多COPD患者并无好处


  【24drs.com】一篇随机试验显示,稳定型慢性阻塞性肺部疾病(COPD)以及休息时或运动时诱发中度去饱和的患者,长期补充氧气并无显著效果。
  
  研究主席、阿拉巴马大学William C. Bailey医师与代表「长期氧气治疗试验研究小组(Long-Term Oxygen Treatment Trial Research Group)」的研究伙伴写道,我们发现,在到发生死亡时间、到发生第一次住院时间、其它可测量之结果的持续效益方面,长期补充氧气并未提供任何效果。他们的研究结果发表于10月27日新英格兰医学期刊。
  
  研究者最初的研究设计,是要探讨长期给氧到死亡为止对于COPD与中度休息时去饱和(Spo2, 89% - 93%)之患者的效果;不过,因为纳入研究对象的时间拖太久,他们在7个月后修改了研究方法,修订后的试验扩大了纳入标准,加入中度运动诱发去饱和(6分钟行走测试中,Spo2, ≧80% 达≧5分钟以及<90% 达≧10秒)的患者,结果方面则是增加了因为任何原因而第一次住院的时间,作为复合初级结果。
  
  研究者随机指派738名患者:接受补充氧气(n = 368人)或没有补充氧气(n = 370人)。补充氧气组的患者接受24小时给氧-如果他们的休息时Spo2为89%-93% (n = 220人);只在睡眠与运动时给氧-如果他们只有在运动时发生去饱和(n = 148人)。给氧速率为2 L/分钟,研究者追踪这些患者1-6年。
  
  补充氧气组与没有补充氧气组,在到死亡的时间或发生第一次住院的时间,并无显著差异(风险比[HR], 0.94; 95%信赖区间[CI], 0.79 - 1.12; P = .52)。两组在所有住院比率(比率比值[RR], 1.01; 95% CI, 0.91 - 1.13)、COPD恶化(RR, 1.08; 95% CI, 0.98 - 1.19)以及COPD相关住院(RR, 0.99; 95% CI, 0.83 - 1.17)也没有显著差异。
  
  补充氧气组中,到死亡的时间或发生第一次住院的时间,比较长的人,分别是在纳入前1-3个月发生COPD恶化(HR, 0.58; 95% CI, 0.39 - 0.88; 交互影响P = .007)、纳入时71岁以上(HR, 0.75; 95% CI, 0.57 - 0.99; 交互影响P = .03)或纳入时生活质量报告较低(福祉质量量表分数<0.55)(HR, 0.77; 95% CI, 0.60 - 0.99;交互影响P = .03),不过,校正多重、预先设定比较之后,这些交互影响都不显著。
  
  在生活质量、焦虑、忧郁、肺功能、6分钟行走距离、其它功能状态测量等方面与开始时相比的变化上,两组之间并无一致性的差异。
  
  瑞典Karlskrona Blekinge医院内科、Lund大学呼吸医学与过敏学科临床科学系Magnus Ekstrom医师在编辑评论写道,这篇指标性的研究是迄今有关长期给氧治疗的最大型研究。研究结果的有效性是,在各项结果一致缺乏效果,而且这并不因氧气处方类型、去饱和模式、氧气使用、性别、吸菸状态和肺功能而改变。
  
  我相信,根据目前所有可以获得的资料,长期给氧治疗处方给COPD患者以延长存活时,患者应为慢性(>3周)严重休息时低血氧(Pao2 ≦55 mm Hg)者。
  
  资料来源:http://www.24drs.com/
  
  Native link:Supplemental Oxygen No Benefit for Many With COPD

Supplemental Oxygen No Benefit for Many With COPD

By Troy Brown, RN
Medscape Medical News

Patients with stable chronic obstructive pulmonary disease (COPD) and resting or exercise-induced moderate desaturation do not appear to benefit from long-term supplemental oxygen, a randomized trial shows.

"[W]e found that long-term supplemental oxygen did not provide any benefit with respect to the time to death or first hospitalization or any sustained benefit with respect to any other measured outcome," write study chair William C. Bailey, MD, from the University of Alabama, Birmingham, and colleagues on behalf of the Long-Term Oxygen Treatment Trial Research Group. They report their findings in an article published in the October 27 issue of New England Journal of Medicine.

The investigators originally designed the trial to study the effect of long-term supplemental oxygen on time to death in patients with COPD and moderate resting desaturation (Spo2, 89% - 93%); however, they revised their study after 7 months as a result of slow recruitment. The amended trial expanded the inclusion criteria, allowing patients with moderate exercise-induced desaturation (during the 6-minute walk test, Spo2, ?80% for ?5 minutes and <90% for ?10 seconds), and added the outcome of time to first hospitalization for any cause as a composite primary outcome.

The investigators randomly assigned 738 patients to receive supplemental oxygen (n = 368) or no supplemental oxygen (n = 370). Patients in the supplemental oxygen group received 24-hour oxygen if their resting Spo2 was 89% to 93% (n = 220) and oxygen only during sleep and exercise if they only experienced desaturation during exercise (n = 148). Oxygen was given at 2 L/minute. The researchers followed the patients for from 1 to 6 years.

Time to death or first hospitalization did not differ significantly between the supplemental oxygen group and the no supplemental oxygen group in the time to death or first hospitalization (hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.79 - 1.12; P = .52). The rates of all hospitalizations (rate ratio [RR], 1.01; 95% CI, 0.91 - 1.13), COPD exacerbations (RR, 1.08; 95% CI, 0.98 - 1.19), and COPD-related hospitalizations (RR, 0.99; 95% CI, 0.83 - 1.17) also did not differ significantly between the two groups.

Time to death or first hospitalization was longer in patients in the supplemental oxygen group who experienced a COPD exacerbation 1 to 3 months before enrollment (HR, 0.58; 95% CI, 0.39 - 0.88; P = .007 for interaction), were 71 years of age or older at enrollment (HR, 0.75; 95% CI, 0.57 - 0.99; P = .03 for interaction), or reported a lower quality of life (Quality of Well-Being Scale score, <0.55) at enrollment (HR, 0.77; 95% CI, 0.60 - 0.99; P = .03 for interaction). However, none of these interactions was significant after adjustment for multiple, prespecified comparisons.

There were no consistent differences between the study groups in the change from baseline in measures of quality of life, anxiety, or depression or in lung function, distance walked in 6 minutes, or other measures of functional status.

"This landmark study is the largest to date with regard to long-term oxygen therapy," Magnus Ekstrom, MD, PhD, from the Department of Clinical Sciences, Division of Respiratory Medicine and Allergology, Lund University, and the Department of Medicine, Blekinge Hospital, Karlskrona, Sweden, writes in an accompanying editorial. "The validity of the findings is supported by the consistent lack of effect across outcomes, which was not modified by type of oxygen prescription, desaturation profile, oxygen use, sex, smoking status, and lung function," he adds.

"I believe that on the basis of all available current data, long-term oxygen therapy should be prescribed to prolong survival among patients with COPD who have chronic (>3 weeks) severe resting hypoxemia (Pao2 of ?55 mm Hg or Sao

Dr Bailey has disclosed no relevant financial relationships. Several coauthors reported various financial relationships with Novartis, Boehringer Ingelheim, AstraZeneca, GlaxoSmithKline, Astellas Pharma, ICON Medical Imaging, Breathe Technologies, Ventec Life Systems, Bayer, Centocor, Gilead Sciences, Takeda Pharmaceuticals (formerly Nycomed), Afferent Pharmaceuticals, Forest Laboratories, Janssen, Pearl Therapeutics, Ikaria, Bellerophon Therapeutics (formerly Ikaria), Kadmon, Pfizer, Veracyte, Roche, Sunovion Pharmaceuticals, Theravance Biopharma, Concert Pharmaceuticals, Biogen (formerly Stromedix), AcademicCME, MedEd Consulting, Continuing Education, Potomac Center for Medical Education, CME Incite, Annenberg Center for Health Sciences at Eisenhower, Integritas Communications, inThought Research, Miller Medical Communications, Paradigm Medical Communications, PeerVoice, HayMarket Communications, Prime Healthcare, WebMD, PeerView Academic Network, Axon Communications, Johnson & Johnson, Clarion Communications, Adept Field Solutions, Proterixbio (formerly Bioscale), Unity Biotechnology, Lucid Communique Medical Education, Baxalta, CSL Behring, Grifols, Arrowhead Pharmaceuticals, Bristol-Myers Squibb, ContraFect, Mylan, Pulmonx, Spiration, Teva Pharmaceutical Industries, Verona Pharma, and Vertex Pharmaceuticals. The remaining authors and Dr Ekstrom have disclosed no relevant financial relationships.

N Engl J Med. 2016;375:1617-1627, 1683-1684.

    
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