海水鼻腔冲洗在 COVID-19 和上呼吸道感染中减少症状持续时间和病毒载量的随机对照多中心试验。

Seawater nasal wash to reduce symptom duration and viral load in COVID-19 and upper respiratory tract infections: a randomized controlled multicenter trial.

机构信息

Department of Otolaryngology (ENT) and Head & Neck Surgery, Bordeaux University Hospital, Bordeaux, France.

University of Bordeaux, 33000, Bordeaux, France.

出版信息

Eur Arch Otorhinolaryngol. 2024 Jul;281(7):3625-3637. doi: 10.1007/s00405-024-08518-y. Epub 2024 Feb 20.

DOI:10.1007/s00405-024-08518-y

PMID:38376591

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11211132/

Abstract

PURPOSE

The objective was to assess the efficacy of seawater nasal wash on symptom duration, intranasal viral load, household transmission in COVID-19 and URTIs.

METHODS

This prospective, randomized, controlled, multicentric, parallel study included 355 mild/moderate COVID-19 and URTI adults with rhinologic symptoms ≤ 48h. Active group performed 4-daily nasal washes with undiluted isotonic seawater versus control group (without nasal wash). Symptoms were self-assessed daily using the WURSS-21 questionnaire for 3 weeks. Viral load was measured by RT-PCR on nasopharyngeal swabs collected on Day 0, Day 5, Day 14 and Day 21. Digital droplet PCR was additionally performed for SARS-CoV-2.

RESULTS

Overall COVID-19 subjects recovered earlier the ability to accomplish daily activities in the active group (- 1.6 day, p = 0.0487) with earlier improvement of taste (- 2 days, p = 0.0404). COVID-19 subjects with severe nasal symptoms at D0 showed the earliest resolution of anosmia (- 5.2 days, p = 0.0281), post-nasal drip (- 4.1 days, p = 0.0102), face pain/heaviness (- 4.5 days, p = 0.0078), headache (- 3.1 days, p = 0.0195), sore throat (- 3.3 days, p = 0.0319), dyspnea (- 3.1 days, p = 0.0195), chest congestion (- 2.8 days, p = 0.0386) and loss of appetite (- 4.5 days, p = 0.0186) with nasal wash. In URTIs subjects, an earlier resolution of rhinorrhea (- 3.5 days, p = 0.0370), post-nasal drip (- 3.7 days, p = 0.0378), and overall sickness (- 4.3 days, p = 0.0248) was reported with nasal wash. Evolution towards more severe COVID-19 was lower in active vs control, with earlier viral load reduction in youngest subjects (≥ 1.5log10 copies/10000 cells at Day 5: 88.9% vs 62.5%, p = 0.0456). In the active group, a lower percentage of SARS-CoV-2 positive household contacts (0-10.7%) was reported vs controls (3.2-16.1%) among subjects with Delta variant (p = 0.0413).

CONCLUSION

This trial showed the efficacy and safety of seawater nasal wash in COVID-19 and URTIs.

TRIAL REGISTRATION

Trial registry ClinicalTrials.gov: NCT04916639. Registration date: 04.06.2021.

摘要

目的

评估海水鼻腔冲洗在 COVID-19 和 URTI 患者症状持续时间、鼻内病毒载量、家庭传播中的疗效。

方法

本前瞻性、随机、对照、多中心、平行研究纳入了 355 名有鼻症状≤48 小时的轻度/中度 COVID-19 和 URTI 成人。实验组每天进行 4 次未经稀释的等渗海水鼻腔冲洗，对照组（不进行鼻腔冲洗）。在 3 周内，使用 WURSS-21 问卷每天自我评估症状。在第 0 天、第 5 天、第 14 天和第 21 天通过 RT-PCR 检测鼻咽拭子中的病毒载量。此外，还进行了数字液滴 PCR 以检测 SARS-CoV-2。

结果

总体而言，实验组 COVID-19 患者更早地恢复了日常活动能力（-1.6 天，p=0.0487），味觉改善更早（-2 天，p=0.0404）。D0 时鼻部症状严重的 COVID-19 患者最早恢复嗅觉障碍（-5.2 天，p=0.0281）、后鼻滴注（-4.1 天，p=0.0102）、面部疼痛/沉重（-4.5 天，p=0.0078）、头痛（-3.1 天，p=0.0195）、咽痛（-3.3 天，p=0.0319）、呼吸困难（-3.1 天，p=0.0195）、胸部充血（-2.8 天，p=0.0386）和食欲不振（-4.5 天，p=0.0186）。URTIs 患者使用鼻腔冲洗后，鼻漏（-3.5 天，p=0.0370）、后鼻滴注（-3.7 天，p=0.0378）和整体疾病（-4.3 天，p=0.0248）更早缓解。与对照组相比，实验组病情向更严重 COVID-19 发展的比例更低，在年龄最小的患者（≥1.5log10 拷贝/10000 个细胞在第 5 天：88.9% vs 62.5%，p=0.0456）中，病毒载量更早降低。在实验组中，与对照组（3.2-16.1%）相比，Delta 变异株患者家庭接触者 SARS-CoV-2 阳性率（0-10.7%）较低（p=0.0413）。