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经鼻高流量湿化空氧疗急性偏头痛:一项随机对照试验。

Trans-nasal high-flow dehumidified air in acute migraine headaches: A randomized controlled trial.

机构信息

Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Department of Internal Medicine, Mount Sinai St. Lukes-Roosevelt, New York, NY, USA.

出版信息

Cephalalgia. 2021 Aug;41(9):968-978. doi: 10.1177/0333102421997766. Epub 2021 Feb 25.

Abstract

BACKGROUND

Intranasal high flow of dehumidified (dry) air results in evaporative cooling of nasal passages. In this randomized clinical trial, we investigated the effect of dry gas induced nasal cooling on migraine headaches.

METHODS

In this single-blind study, acute migraineurs were randomized to either nasal high-flow dry oxygen, dry air, humidified oxygen or humidified air (control) at 15 L/min for 15 min. All gases were delivered at 37°C. Severity of headache and other migraine associated symptoms (International Classification for Headache Disorders, 3rd edition criteria) were recorded before and after therapy. The primary endpoint was change in pain scores, while changes in nausea, photosensitivity and sound sensitivity scores served as secondary endpoints. A linear regression model was employed to estimate the impact of individual treatment components and their individual interactions.

RESULTS

Fifty-one patients (48 ± 15 years of age, 82% women) were enrolled. When compared to the control arm (humidified air), all therapeutic arms showed a significantly greater reduction in pain scores (primary endpoint) at 2 h of therapy with dry oxygen (-1.6 [95% CI -2.3, -0.9]), dry air (-1.7 [95% CI -2.6, -0.7)]), and humidified oxygen (-2.3 [95% CI -3.5, -1.1]). A significantly greater reduction in 2-h photosensitivity scores was also noted in all therapeutic arms (-1.8 [95% CI -3.2, -0.4], dry oxygen; -1.7 [95% CI -2.9, -0.4], dry air; (-2.1 [95% CI -3.6, -0.6], humidified oxygen) as compared to controls. The presence of oxygen and dryness were independently associated with significant reductions in pain and photosensitivity scores. No adverse events were reported.

CONCLUSION

Trans-nasal high-flow dry gas therapy may have a role in reducing migraine associated pain. NCT04129567.

摘要

背景

经鼻高流量输送去湿(干燥)空气会导致鼻腔通道蒸发冷却。在这项随机临床试验中,我们研究了干燥气体诱导的鼻腔冷却对偏头痛的影响。

方法

在这项单盲研究中,急性偏头痛患者被随机分配到经鼻高流量干燥氧气、干燥空气、湿化氧气或湿化空气(对照)组,以 15 L/min 的流量输送 15 分钟。所有气体均在 37°C 下输送。治疗前后记录头痛严重程度和其他偏头痛相关症状(国际头痛疾病分类,第 3 版标准)。主要终点是疼痛评分的变化,而恶心、光敏感和声音敏感评分的变化则作为次要终点。采用线性回归模型估计单个治疗成分及其个体相互作用的影响。

结果

共纳入 51 例患者(48±15 岁,82%为女性)。与对照臂(湿化空气)相比,所有治疗臂在治疗 2 小时时疼痛评分(主要终点)均显著降低,其中干燥氧气组为-1.6(95%CI-2.3,-0.9),干燥空气组为-1.7(95%CI-2.6,-0.7)),湿化氧气组为-2.3(95%CI-3.5,-1.1)。所有治疗臂在治疗 2 小时时的光敏感评分也显著降低(-1.8[95%CI-3.2,-0.4],干燥氧气;-1.7[95%CI-2.9,-0.4],干燥空气;-2.1[95%CI-3.6,-0.6],湿化氧气),与对照组相比。氧气和干燥的存在与疼痛和光敏感评分的显著降低独立相关。未报告不良事件。

结论

经鼻高流量干燥气体治疗可能在减轻偏头痛相关疼痛方面发挥作用。NCT04129567。

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