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鼻塞式高流量湿化氧疗治疗普通感冒的随机对照试验。

Rhinothermy delivered by nasal high flow therapy in the treatment of the common cold: a randomised controlled trial.

机构信息

Medical Research Institute of New Zealand, Wellington, New Zealand

Medical Research Institute of New Zealand, Wellington, New Zealand.

出版信息

BMJ Open. 2021 Nov 30;11(11):e047760. doi: 10.1136/bmjopen-2020-047760.

DOI:10.1136/bmjopen-2020-047760
PMID:34848508
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8634207/
Abstract

BACKGROUND

The common cold is the most common infectious disease affecting humans and has a substantial economic impact on society. Human rhinoviruses, which cause almost two-thirds of colds, have demonstrated temperature-dependent replication which is optimal between 33°C and 35°C.

METHODS

This randomised, single-blind, parallel-group trial completed at a single-centre in New Zealand, recruited 170 participants aged 18-75 years (mean age 27.5 years) who were within 48 hours of common cold symptom onset and had a symptom score (the Modified Jackson Score (MJS)) ≥7 and a negative point-of-care test for influenza. Participants were blinded to the intervention and randomised (1:1) to 5 days of either nasal high flow rhinothermy (rNHF) (100% humidified air delivered at 35 L/min and 41°C for 2 hours daily) (n=85) or 'sham' rhinothermy (100% humidified air delivered at 10 L/min and 31°C for 10 min daily) (n=85) and completed daily symptom diaries, which included the MJS, for 14 days, to investigate whether rNHF reduced common cold symptom severity and duration compared with 'sham' rhinothermy.

RESULTS

An intention-to-treat superiority analysis included all randomised participants and showed no difference between treatment groups for the primary outcome, the day 4 MJS analysed by analysis of covariance: mean (SD) 6.33 (3.97) for rNHF vs 5.8 (3.15) for 'sham'; estimated difference (95% CI) 0.37 (-0.69 to 1.42), p=0.49. There was no difference in time until resolution of symptoms: mean (SD) 5.96 (4.47) days for rNHF vs 6.42 (4.09) days for 'sham'; estimated difference (95% CI) 1.02 (0.75 to 1.38), p=0.91. There were no serious adverse events related to the study treatments.

CONCLUSIONS

This well-powered, single-blind randomised controlled trial does not provide evidence that 5 days of rNHF (100% humidified air heated to 41°C delivered at 35 L/min for 2 hours daily) reduces common cold symptom severity or duration. However, investigation of rNHF in the treatment of influenza is warranted.

TRIAL REGISTRATION NUMBER

ACTRN12617001340325.

摘要

背景

普通感冒是影响人类的最常见传染病,对社会造成了巨大的经济影响。引起近三分之二感冒的人类鼻病毒的复制具有温度依赖性,在 33°C 至 35°C 之间最佳。

方法

这项在新西兰一个单一中心进行的随机、单盲、平行组试验招募了 170 名年龄在 18-75 岁(平均年龄 27.5 岁)的参与者,他们在普通感冒症状发作后 48 小时内,症状评分(改良杰克逊评分(MJS))≥7,并且流感即时检测呈阴性。参与者对干预措施和随机分组(1:1)到 5 天的鼻腔高流量热疗(rNHF)(100%加湿空气以 35L/min 和 41°C 输送 2 小时/天)(n=85)或“假”热疗(100%加湿空气以 10L/min 和 31°C 输送 10 分钟/天)(n=85),并在 14 天内每天填写症状日记,包括 MJS,以调查 rNHF 是否与“假”热疗相比减轻普通感冒症状的严重程度和持续时间。

结果

意向治疗优势分析包括所有随机参与者,在主要结局(通过协方差分析分析的第 4 天 MJS)上,治疗组之间没有差异:rNHF 组的平均值(SD)为 6.33(3.97),而“假”组为 5.8(3.15);估计差异(95%CI)为 0.37(-0.69 至 1.42),p=0.49。症状缓解的时间也没有差异:rNHF 组的平均值(SD)为 5.96(4.47)天,“假”组为 6.42(4.09)天;估计差异(95%CI)为 1.02(0.75 至 1.38),p=0.91。与研究治疗相关的没有严重不良事件。

结论

这项充分-powered、单盲随机对照试验并未提供证据表明 5 天的 rNHF(以 35L/min 的速度加热至 41°C 的 100%加湿空气输送 2 小时/天)可减轻普通感冒症状的严重程度或持续时间。然而,值得研究 rNHF 治疗流感的效果。

试验注册号

ACTRN12617001340325。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e26/8634207/dfc7a319ad99/bmjopen-2020-047760f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e26/8634207/1330243c5d56/bmjopen-2020-047760f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e26/8634207/4967357f7748/bmjopen-2020-047760f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e26/8634207/dfc7a319ad99/bmjopen-2020-047760f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e26/8634207/1330243c5d56/bmjopen-2020-047760f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e26/8634207/4967357f7748/bmjopen-2020-047760f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e26/8634207/dfc7a319ad99/bmjopen-2020-047760f03.jpg

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本文引用的文献

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Protocol for a randomised, single-blind, two-arm, parallel-group controlled trial of the efficacy of rhinothermy delivered by nasal high flow therapy in the treatment of the common cold.一项随机、单盲、双臂、平行对照临床试验方案,旨在评估经鼻高流量治疗(nasal high flow therapy)输送的鼻腔热疗(rhinothermy)治疗普通感冒的疗效。
BMJ Open. 2019 Jun 19;9(6):e028098. doi: 10.1136/bmjopen-2018-028098.
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Effects of high temperature on pandemic and seasonal human influenza viral replication and infection-induced damage in primary human tracheal epithelial cell cultures.高温对人原代气管上皮细胞培养物中甲型流感病毒大流行株和季节性流行株复制及感染所致损伤的影响
Heliyon. 2019 Feb 5;5(2):e01149. doi: 10.1016/j.heliyon.2019.e01149. eCollection 2019 Feb.
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Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study.鼻腔热疗治疗普通感冒的随机对照试验:一项可行性研究。
BMJ Open. 2018 Mar 27;8(3):e019350. doi: 10.1136/bmjopen-2017-019350.
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Heated, humidified air for the common cold.用于治疗普通感冒的温热、湿润空气。
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