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高流量氧疗和双水平气道正压通气治疗晚期癌症患者持续性呼吸困难的随机 II 期试验。

High-flow oxygen and bilevel positive airway pressure for persistent dyspnea in patients with advanced cancer: a phase II randomized trial.

机构信息

Department of Palliative Care and Rehabilitation Medicine, M.D. Anderson Cancer Center, Houston, Texas, USA.

出版信息

J Pain Symptom Manage. 2013 Oct;46(4):463-73. doi: 10.1016/j.jpainsymman.2012.10.284. Epub 2013 Jun 2.

Abstract

CONTEXT

Dyspnea is one of the most distressing symptoms for cancer patients. The role of high-flow oxygen (HFO) and bilevel positive airway pressure (BiPAP) in the palliation of dyspnea has not been well characterized.

OBJECTIVES

To determine the feasibility of conducting a randomized trial of HFO and BiPAP in cancer patients and examine the changes in dyspnea, physiologic parameters, and adverse effects with these modalities.

METHODS

In this randomized study (ClinicalTrials.gov Identifier: NCT01518140), we assigned hospitalized patients with advanced cancer and persistent dyspnea to either HFO or BiPAP for two hours. We assessed dyspnea with a numeric rating scale (NRS) and modified Borg scale (MBS) before and after the intervention. We also documented vital signs, transcutaneous carbon dioxide, and adverse effects.

RESULTS

Thirty patients were enrolled (1:1 ratio) and 23 (77%) completed the assigned intervention. HFO was associated with improvements in both NRS (mean 1.9; 95% CI 0.4-3.4; P = 0.02) and MBS (mean 2.1; 95% CI 0.6-3.5; P = 0.007). BiPAP also was associated with improvements in NRS (mean 3.2; 95% CI 1.3-5.1; P = 0.004) and MBS (mean 1.5; 95% CI -0.3, 3.2; P = 0.13). There were no significant differences between HFO and BiPAP in dyspnea NRS (P = 0.14) and MBS (P = 0.47). Oxygen saturation improved with HFO (93% vs. 99%; P = 0.003), and respiratory rate had a nonstatistically significant decrease with both interventions (HFO -3, P = 0.11; BiPAP -2, P = 0.11). No significant adverse effects were observed.

CONCLUSION

HFO and BiPAP alleviated dyspnea, improved physiologic parameters, and were safe. Our results justify larger randomized controlled trials to confirm these findings.

摘要

背景

呼吸困难是癌症患者最痛苦的症状之一。高流量氧气(HFO)和双水平气道正压通气(BiPAP)在缓解呼吸困难方面的作用尚未得到很好的描述。

目的

确定对癌症患者进行 HFO 和 BiPAP 随机试验的可行性,并研究这些方式对呼吸困难、生理参数和不良反应的影响。

方法

在这项随机研究(ClinicalTrials.gov 标识符:NCT01518140)中,我们将患有晚期癌症且持续呼吸困难的住院患者随机分配至 HFO 或 BiPAP 组,治疗时间为两小时。干预前后,我们使用数字评分量表(NRS)和改良 Borg 量表(MBS)评估呼吸困难。我们还记录生命体征、经皮二氧化碳和不良反应。

结果

共纳入 30 例患者(1:1 比例),23 例(77%)完成了分配的干预。HFO 治疗后 NRS(平均 1.9;95%CI 0.4-3.4;P=0.02)和 MBS(平均 2.1;95%CI 0.6-3.5;P=0.007)均显著改善。BiPAP 治疗后 NRS(平均 3.2;95%CI 1.3-5.1;P=0.004)和 MBS(平均 1.5;95%CI -0.3, 3.2;P=0.13)也显著改善。但 HFO 和 BiPAP 治疗后,NRS(P=0.14)和 MBS(P=0.47)无显著差异。HFO 治疗后血氧饱和度升高(93% vs. 99%;P=0.003),呼吸频率在两种干预措施下均有非统计学意义的下降(HFO -3,P=0.11;BiPAP -2,P=0.11)。未观察到显著不良反应。

结论

HFO 和 BiPAP 可缓解呼吸困难,改善生理参数,且安全。我们的结果证明了进行更大规模的随机对照试验以证实这些发现的合理性。

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