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比较含有倍他米松和地塞米松的鼻喷雾剂与含有生理盐水或地塞米松的鼻喷雾剂治疗干燥性鼻炎的疗效和安全性。

Tolerability and effects on quality of life of liposomal nasal spray treatment compared to nasal ointment containing dexpanthenol or isotonic NaCl spray in patients with rhinitis sicca.

机构信息

Institute of Medical Statistics, Informatics and Epidemiology (IMSIE), University of Cologne, 50924 Cologne, Germany.

出版信息

Eur Arch Otorhinolaryngol. 2013 Sep;270(9):2465-72. doi: 10.1007/s00405-013-2362-y. Epub 2013 Jan 31.

Abstract

This study aimed to investigate symptom reduction via the liposomal nasal spray LipoNasal (LN) in patients with rhinitis sicca. Tolerability and the impact on quality of life were also examined. The same parameters were established in parallel for treatment approaches with Bepanthen (BP) nasal ointment containing dexpanthenol and the Rhinomer (RH) nasal spray containing NaCl. This prospective, controlled, open-label observation study was a multicenter trial. 92 patients with rhinitis sicca were allocated to three arms according to their symptoms: LN: n = 33; BP: n = 32 and RH: n = 27. The study comprised three visits at an interval of 14 days. Efficacy was examined by the Rhinitis Sicca Symptom Score (RSSS) documented daily and at the visits based on an endoscopic evaluation. The nasal spray sensory scale was used to investigate the tolerability. Quality of life (QoL) was measured by means of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and the "Short Form 12" of the "Impact on Health-Related Quality of Life (HRQL)" questionnaire on general quality of life. Nasal symptoms improved significantly (p = 0.001) under all three treatment approaches, reflected by the reduction in the RSSS and the Endoscopy Sum Score. A comparison of the three groups showed that no therapy was significantly superior to any of the others (p = 0.410). The tolerability of all treatments was good. Concerning the nasal moisturization, LipoNasal was evaluated better than Bepanthen and Rhinomer. Quality of life improved in all groups, but not significantly. The results show good efficacy and tolerability of the liposomal nasal spray compared to generally recognized treatments of rhinitis sicca with dexpanthenol nasal ointment and NaCl nasal spray. LipoNasal therefore constitutes a good treatment for patients suffering from dry nose.

摘要

本研究旨在探讨脂质体鼻喷剂 LipoNasal(LN)在干燥性鼻炎患者中减轻症状的效果。同时还考察了其耐受性和对生活质量的影响。为了进行比较,我们还设立了使用含有泛醇的 Bepanthen(BP)鼻软膏和含有 NaCl 的 Rhinomer(RH)鼻喷雾剂的治疗方案,并对这些方案进行了平行研究。这是一项前瞻性、对照、开放性观察研究,采用多中心试验设计。将 92 例干燥性鼻炎患者根据症状分为三组,分别接受 LN(n = 33)、BP(n = 32)和 RH(n = 27)治疗。研究包括三个 14 天的访视点。通过患者每天记录和就诊时的干燥性鼻炎症状评分(RSSS)以及内镜评估来评估疗效。采用鼻腔喷雾感觉量表来评估耐受性。采用 Rhinoconjunctivitis 生活质量问卷(RQLQ)和“健康相关生活质量(HRQL)问卷的短式 12 项”(SF-12)来评估生活质量。所有三种治疗方法均显著改善了鼻腔症状(p = 0.001),这反映在 RSSS 和内镜总评分的降低上。三组之间的比较显示,没有一种治疗方法明显优于其他任何一种(p = 0.410)。所有治疗的耐受性均良好。在鼻腔保湿方面,LipoNasal 的评价优于 BP 和 RH。所有组的生活质量均有所改善,但无统计学意义。研究结果表明,与普遍认可的含有泛醇的鼻软膏和 NaCl 鼻喷雾剂治疗干燥性鼻炎的方法相比,脂质体鼻喷剂具有良好的疗效和耐受性。因此,LipoNasal 是治疗干燥性鼻炎患者的一种有效方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6c1/3731516/99d3976de7c1/405_2013_2362_Fig1_HTML.jpg

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