评估鼻腔医疗器械（NESOSPRAY HE-G）治疗急性鼻窦炎的有效性与安全性：一项随机、双盲、安慰剂对照临床试验

文献信息

中文摘要

背景与目的： 急性鼻窦炎与生活质量显著下降相关，包括鼻塞、面部压迫感、咳嗽和睡眠障碍等症状。人们对非药物管理策略的兴趣日益增长，尤其是在全身治疗可能受限的人群中，例如儿科患者和孕妇。NESOSPRAY HE-G是一种鼻腔器械，含有成膜性甘油制剂，旨在形成保护屏障并诱导渗透效应，从而促进鼻腔减充血和黏膜保护。
材料与方法： 开展了一项随机、双盲、安慰剂对照研究，以评估NESOSPRAY HE-G（n = 20）与生理盐水对照（n = 20）在3岁及以上、表现为急性鼻窦炎且基线鼻-鼻窦炎严重程度评分（RSSS）至少为25/50的患者中的性能和安全性。研究产品以每侧鼻孔三喷、每日四次给药，最长持续15天或直至症状缓解。疗效主要通过总RSSS以及关键症状（包括鼻塞、面部疼痛、咳嗽、睡眠障碍和发热）的变化来评估。安全性评估包括监测不良事件（AE）和评估局部耐受性。
结果： 两组基线特征相当。NESOSPRAY HE-G治疗从第2天起导致总RSSS出现统计学显著降低，并在整个研究期间持续有效。在个体症状方面也观察到改善，包括鼻塞的早期缓解以及咳嗽和面部疼痛的减轻，与对照相比起效更快。睡眠质量呈渐进性改善。两组均出现发热消退，NESOSPRAY HE-G组观察到更早的效果。未报告严重不良事件（SAE）或超敏反应。该产品表现出良好的耐受性。
结论： NESOSPRAY HE-G可快速且持续地缓解急性鼻窦炎相关症状。其基于渗透活性和屏障形成的局部作用模式，代表了一种合适的非药物选择，尤其适用于寻求全身治疗替代方案或存在此类治疗禁忌症的患者。

英文摘要

Background and Objectives: Acute rhinosinusitis is associated with a substantial deterioration in quality of life, including symptoms such as nasal obstruction, facial pressure, cough, and sleep disruption. Growing interest in non-pharmacological management strategies has been observed, particularly among populations in whom systemic treatments may be limited, such as pediatric patients and pregnant individuals. NESOSPRAY HE-G is a nasal device containing a filmogenic glycerol formulation designed to create a protective barrier and induce an osmotic effect, thereby promoting nasal decongestion and mucosal protection. Materials and Methods: A randomized, double-blind, placebo-controlled study was conducted to assess the performance and safety of NESOSPRAY HE-G (n = 20) compared with a saline comparator (n = 20) in patients aged 3 years and older presenting with acute rhinosinusitis and a baseline Rhino-Sinusitis Severity Score (RSSS) of at least 25/50. The investigational product was administered as three sprays per nostril, four times daily, over a maximum period of 15 days or until symptom resolution. Efficacy was primarily evaluated through changes in the total RSSS and in key symptoms, including nasal congestion, facial pain, cough, sleep disturbance, and fever. Safety assessments included monitoring adverse events (AE) and evaluating local tolerability. Results: Baseline characteristics were comparable between groups. Treatment with NESOSPRAY HE-G resulted in a statistically significant reduction in total RSSS from Day 2 onwards, with sustained effects throughout the study period. Improvements were also observed across individual symptoms, including early relief of nasal congestion and reductions in cough and facial pain, with faster onset compared to the comparator. Sleep quality showed progressive improvement. Resolution of fever occurred in both groups, with an earlier effect observed in the NESOSPRAY HE-G arm. No serious adverse events (SAE) or hypersensitivity reactions were reported. The product demonstrated good tolerability. Conclusions: NESOSPRAY HE-G provides rapid and sustained alleviation of symptoms associated with acute rhinosinusitis. Its topical mode of action, based on osmotic activity and barrier formation, represents a suitable non-pharmacological option, particularly for patients seeking alternatives to systemic therapies or presenting contraindications to such treatments.