冬季化乳香黄连木油鼻喷雾剂治疗血管运动性鼻炎的 prospective 对照评价

文献信息

中文摘要

背景： 血管运动性鼻炎（VMR）目前被纳入更广泛的非过敏性鼻病谱系，是一种以鼻塞、流涕及对非特异性环境刺激物高反应性为特征的慢性疾病。尽管传统上被认为是由自主神经调节异常驱动的神经血管性疾病，但新出现的证据提示，黏膜炎症和微生物因素可能在部分患者的症状持续中起作用。冬季化乳香黄连木油在上气道实验模型中已显示出抗微生物和抗生物膜特性，提示其在慢性鼻部疾病中可能具有治疗相关性。
方法： 这项前瞻性对照研究评估了一种含有冬季化乳香黄连木油的鼻喷雾医疗器械（Bactorinol®鼻喷雾剂，PharmExtracta S.p.A.，意大利）在VMR患者中的有效性。共纳入120名参与者，110名完成研究（58名治疗组，52名对照组）。主要终点包括峰值鼻吸气流量（PNIF）的变化以及使用鼻窦结局测试（SNOT-22）评估的症状负担。次要终点包括鼻细胞学评估炎症细胞性（中性粒细胞、嗜酸性粒细胞、肥大细胞）、细菌丰度、核上纹以及与生物膜样结构相符的细胞学发现。采用重复测量一般线性模型评估随时间变化的治疗效果。
结果： 与对照组相比，治疗组患者在研究期间表现出显著更大的临床改善。SNOT-22评分在治疗组下降30.5%，而对照组下降9.7%（时间×组别交互作用，p < 0.001）。PNIF在治疗组改善44.5%，而对照组改善20.8%（交互作用p = 0.006）。还观察到治疗相关的显著降低，包括中性粒细胞（p = 0.001）、肥大细胞（p = 0.021）、细菌丰度（p = 0.002）以及与生物膜样结构相符的细胞学发现（p = 0.001）。尽管治疗组在若干参数上基线负担较高，但治疗后结局有利于干预组。
结论： 冬季化乳香黄连木油鼻喷雾剂与VMR患者症状、鼻气流、炎症细胞学及微生物相关细胞学发现的显著改善相关。这些发现支持以下假说：非过敏性鼻部疾病的特定表型可能涉及超出经典神经血管功能障碍的黏膜炎症和微生物成分。需要更大规模的随机研究并结合微生物学和分子特征描述，以确认这些初步发现并阐明作用机制。

英文摘要

BACKGROUND: Vasomotor rhinitis (VMR), currently included within the broader spectrum of non-allergic rhinopathy, is a chronic condition characterized by nasal obstruction, rhinorrhea, and hyperreactivity to non-specific environmental triggers. Although traditionally considered a neurovascular disorder driven by autonomic dysregulation, emerging evidence suggests that mucosal inflammatory and microbial factors may contribute to symptom persistence in selected patients. Winterized Pistacia lentiscus oil has demonstrated antimicrobial and anti-biofilm properties in upper airway experimental models, suggesting potential therapeutic relevance in chronic nasal disorders.
METHODS: This prospective controlled study evaluated the effectiveness of a nasal spray medical device containing winterized Pistacia lentiscus oil (Bactorinol® nasal spray, PharmExtracta S.p.A., Italy) in patients with VMR. A total of 120 participants were enrolled, with 110 completing the study (58 treated, 52 controls). Primary endpoints included changes in Peak Nasal Inspiratory Flow (PNIF) and symptom burden assessed using the Sino-Nasal Outcome Test (SNOT-22). Secondary endpoints included nasal cytological assessment of inflammatory cellularity (neutrophils, eosinophils, mast cells), bacterial abundance, supranuclear stria, and cytological findings compatible with biofilm-like structures. Repeated-measures General Linear Models were used to evaluate treatment effects over time.
RESULTS: Compared with controls, treated patients demonstrated significantly greater clinical improvement over the study period. SNOT-22 scores decreased by 30.5% in the treatment group versus 9.7% in controls (time × group interaction, p < 0.001). PNIF improved by 44.5% in treated subjects compared with 20.8% in controls (p = 0.006 for interaction). Significant treatment-associated reductions were also observed for neutrophils (p = 0.001), mast cells (p = 0.021), bacterial abundance (p = 0.002), and cytological findings compatible with biofilm-like structures (p = 0.001). Although the treatment group presented a higher baseline burden for several parameters, post-treatment outcomes favored the intervention group.
CONCLUSIONS: Winterized Pistacia lentiscus oil nasal spray was associated with significant improvements in symptoms, nasal airflow, inflammatory cytology, and microbial-related cytological findings in patients with VMR. These findings support the hypothesis that selected phenotypes of non-allergic nasal disease may involve mucosal inflammatory and microbial components beyond classical neurovascular dysfunction. Larger randomized studies with microbiological and molecular characterization are warranted to confirm these preliminary findings and clarify mechanisms of action.