Nonoyama Mika L, Brooks Dina, Guyatt Gordon H, Goldstein Roger S
West Park Healthcare Centre, 82 Buttonwood Avenue, Toronto, ON, M6M 2J5 Canada.
Am J Respir Crit Care Med. 2007 Aug 15;176(4):343-9. doi: 10.1164/rccm.200702-308OC. Epub 2007 Apr 19.
Ambulatory oxygen improves acute exercise performance in people with chronic obstructive pulmonary disease (COPD). This improvement may not translate into symptomatic benefit for patients during activities of daily living.
We undertook a series of individual randomized controlled trials (N-of-1 RCTs) to measure the effect of oxygen in patients with COPD who do not meet criteria for mortality reduction with long-term oxygen therapy.
Twenty-seven patients completed blinded N-of-1 RCTs, each comprising three pairs of 2-week home treatment periods, with oxygen provided during one period of each pair and a placebo mixture during the other.
Patients completed the Chronic Respiratory Questionnaire (CRQ), the St. George's Respiratory Questionnaire, and a home five-minute-walk test at the end of each period. We defined a positive response as a CRQ dyspnea score greater (less dyspnea) on oxygen than placebo during all three pairs of treatment periods, with a difference >or= 0.5 inches for at least two treatment pairs. Oxygen significantly increased the five-minute-walk test (427 vs. 412 steps, p = 0.04). Two of 27 patients met the responder criteria. Among the whole group, neither the CRQ nor the St. George's Respiratory Questionnaire showed any statistical or clinical differences between oxygen and placebo.
This study does not support the general application of long-term ambulatory oxygen therapy for patients with COPD who do not meet criteria for mortality reduction with long-term oxygen therapy. N-of-1 RCTs can identify patients who may benefit.
动态吸氧可改善慢性阻塞性肺疾病(COPD)患者的急性运动表现。但这种改善可能不会转化为患者在日常生活活动中的症状改善。
我们进行了一系列单病例随机对照试验(N-of-1 RCTs),以测量吸氧对不符合长期氧疗降低死亡率标准的COPD患者的影响。
27名患者完成了盲法N-of-1 RCTs,每个试验包括三对为期2周的家庭治疗期,每对中的一个时期提供氧气,另一个时期提供安慰剂混合物。
患者在每个治疗期结束时完成慢性呼吸问卷(CRQ)、圣乔治呼吸问卷,并进行一次家庭五分钟步行测试。我们将阳性反应定义为在所有三对治疗期内,吸氧时的CRQ呼吸困难评分高于(呼吸困难减轻)安慰剂,且至少两对治疗期的差异≥0.5英寸。吸氧显著增加了五分钟步行测试的步数(427步对412步,p = 0.04)。27名患者中有2名符合反应者标准。在整个组中,CRQ和圣乔治呼吸问卷在吸氧和安慰剂之间均未显示出任何统计学或临床差异。
本研究不支持对不符合长期氧疗降低死亡率标准的COPD患者普遍应用长期动态吸氧疗法。单病例随机对照试验可以识别可能受益的患者。