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。