海水基鼻腔冲洗对普通感冒婴幼儿鼻塞的疗效和安全性：一项随机对照试验。

文献信息

中文摘要

背景： 与普通感冒相关的鼻塞是婴幼儿痛苦的常见来源。虽然高渗海水溶液通过渗透作用提供了一种生理性减充血机制，但支持其作为标准护理辅助手段用于这一特定儿科人群的强有力临床证据对于验证其治疗价值至关重要。
目的： 评估富含铜和锰的高渗海水鼻腔喷雾剂联合标准护理与单独标准护理相比，在缓解3-48月龄、无高热（排除急性鼻窦炎）的普通感冒婴幼儿鼻塞、改善睡眠质量和加速症状恢复方面的疗效和安全性。
方法： 在一项随机、开放标签、对照平行研究中，220名参与者接受标准护理（包括充足补水、居家休息以及按需使用对乙酰氨基酚），并联合或不联合鼻腔喷雾剂。通过问卷在10天内评估结局，包括症状严重程度、恢复率、睡眠质量、继发感染和照护者满意度。
结果： 使用鼻腔喷雾剂的参与者在第0天晚间至第5天鼻塞显著减轻（p < 0.05），并在使用后5-15分钟内观察到症状即刻缓解。到第10天，鼻腔喷雾剂组的恢复率更高（75.3% vs. 58.5%）。咳嗽和流涕严重程度的改善显著，但其他症状的影响甚微。两组之间的睡眠质量和继发感染率相当。照护者表示高度满意，93.6%愿意再次使用该产品。未发现与鼻腔喷雾剂相关的不良事件。
结论： 高渗海水溶液鼻腔喷雾剂是标准护理的一种安全有效的辅助手段，可为幼儿快速缓解鼻塞并提高感冒恢复率。试验注册于ClinicalTrials.gov：NCT05365789（https://clinicaltrials.gov/search?cond=NCT05365789）。

英文摘要

BACKGROUND: Nasal congestion associated with the common cold is a frequent source of distress in infants and toddlers. While hypertonic seawater solutions offer a physiological mechanism for decongestion via osmosis, robust clinical evidence supporting their use as an adjunct to standard care in this specific pediatric population is essential to validate their therapeutic value.
OBJECTIVE: To evaluate the efficacy and safety of a hypertonic seawater nasal spray enriched with copper and manganese combined with standard of care compared to standard of care alone in alleviating nasal congestion, improving sleep quality, and accelerating symptom recovery in infants and toddlers aged 3-48 months experiencing the common cold without high fever (excluding acute rhinosinusitis).
METHODS: In a randomized, open-label, controlled parallel study, 220 participants received standard care (which included ample hydration, at-home rest, and the use of paracetamol as needed) with or without the nasal spray. Outcomes, including symptom severity, recovery rate, sleep quality, secondary infections, and caregiver satisfaction, were assessed via questionnaires over 10 days.
RESULTS: Participants using the nasal spray experienced a significant (p < 0.05) reduction in nasal congestion from the evening of Day 0 through Day 5, with immediate symptom relief observed within 5-15 min of application. By Day 10, recovery rates were higher in the nasal spray group (75.3% vs. 58.5%). Improvements in cough and runny nose severity were significant, though minimal effects were noted for other symptoms. Sleep quality and secondary infection rates were comparable between groups. Caregivers expressed high satisfaction, with 93.6% willing to use the product again. No adverse events were linked to the nasal spray.
CONCLUSION: The hypertonic seawater solution nasal spray is a safe and effective adjunct to standard care, providing rapid relief of nasal congestion and improving cold recovery rates in young children. Trial registered at ClinicalTrials.gov: NCT05365789 ( https://clinicaltrials.gov/search?cond=NCT05365789 ).