補充氧氣對許多COPD患者並無好處


  【24drs.com】一篇隨機試驗顯示,穩定型慢性阻塞性肺部疾病(COPD)以及休息時或運動時誘發中度去飽和的患者,長期補充氧氣並無顯著效果。
  
  研究主席、阿拉巴馬大學William C. Bailey醫師與代表「長期氧氣治療試驗研究小組(Long-Term Oxygen Treatment Trial Research Group)」的研究夥伴寫道,我們發現,在到發生死亡時間、到發生第一次住院時間、其他可測量之結果的持續效益方面,長期補充氧氣並未提供任何效果。他們的研究結果發表於10月27日新英格蘭醫學期刊。
  
  研究者最初的研究設計,是要探討長期給氧到死亡為止對於COPD與中度休息時去飽和(Spo2, 89% - 93%)之患者的效果;不過,因為納入研究對象的時間拖太久,他們在7個月後修改了研究方法,修訂後的試驗擴大了納入標準,加入中度運動誘發去飽和(6分鐘行走測試中,Spo2, ≧80% 達≧5分鐘以及<90% 達≧10秒)的患者,結果方面則是增加了因為任何原因而第一次住院的時間,作為複合初級結果。
  
  研究者隨機指派738名患者:接受補充氧氣(n = 368人)或沒有補充氧氣(n = 370人)。補充氧氣組的患者接受24小時給氧-如果他們的休息時Spo2為89%-93% (n = 220人);只在睡眠與運動時給氧-如果他們只有在運動時發生去飽和(n = 148人)。給氧速率為2 L/分鐘,研究者追蹤這些患者1-6年。
  
  補充氧氣組與沒有補充氧氣組,在到死亡的時間或發生第一次住院的時間,並無顯著差異(風險比[HR], 0.94; 95%信賴區間[CI], 0.79 - 1.12; P = .52)。兩組在所有住院比率(比率比值[RR], 1.01; 95% CI, 0.91 - 1.13)、COPD惡化(RR, 1.08; 95% CI, 0.98 - 1.19)以及COPD相關住院(RR, 0.99; 95% CI, 0.83 - 1.17)也沒有顯著差異。
  
  補充氧氣組中,到死亡的時間或發生第一次住院的時間,比較長的人,分別是在納入前1-3個月發生COPD惡化(HR, 0.58; 95% CI, 0.39 - 0.88; 交互影響P = .007)、納入時71歲以上(HR, 0.75; 95% CI, 0.57 - 0.99; 交互影響P = .03)或納入時生活品質報告較低(福祉品質量表分數<0.55)(HR, 0.77; 95% CI, 0.60 - 0.99;交互影響P = .03),不過,校正多重、預先設定比較之後,這些交互影響都不顯著。
  
  在生活品質、焦慮、憂鬱、肺功能、6分鐘行走距離、其他功能狀態測量等方面與開始時相比的變化上,兩組之間並無一致性的差異。
  
  瑞典Karlskrona Blekinge醫院內科、Lund大學呼吸醫學與過敏學科臨床科學系Magnus Ekstrom醫師在編輯評論寫道,這篇指標性的研究是迄今有關長期給氧治療的最大型研究。研究結果的有效性是,在各項結果一致缺乏效果,而且這並不因氧氣處方類型、去飽和模式、氧氣使用、性別、吸菸狀態和肺功能而改變。
  
  我相信,根據目前所有可以獲得的資料,長期給氧治療處方給COPD患者以延長存活時,患者應為慢性(>3週)嚴重休息時低血氧(Pao2 ≦55 mm Hg)者。
  
  資料來源: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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