Bitop AG, Carlo-Schmid-Allee 5, 44263, Dortmund, Germany.
AB-MSC, Am Platz 2, 50129, Bergheim, Germany.
Eur Arch Otorhinolaryngol. 2022 Mar;279(3):1371-1381. doi: 10.1007/s00405-021-06916-0. Epub 2021 Jun 4.
Symptomatic relief of acute rhinosinusitis is commonly achieved with nasal decongestants. The current observational study investigated the efficacy and safety of treatment of acute rhinosinusitis with Ectoin Rhinitis Spray compared to or in combination with Xylometazoline-containing decongesting nasal spray.
Patients with acute rhinosinusitis applied either Ectoin Rhinitis Spray, Xylometazoline nasal spray or a combination of both products. Rhinosinusitis symptoms were assessed, and nasal oedema and endonasal redness were determined by rhinoscopy. Patient diaries based on the validated SNOT (Sino Nasal Outcome Test) questionnaire evaluated rhinosinusitis parameters over time and influences of the disease on quality of life. Following treatment, investigators and patients judged the efficacy and tolerability.
Ectoin Rhinitis Spray diminished common rhinosinusitis symptoms such as nasal obstruction, nasal secretion, facial pain/headache, and smell/taste impairment. Upon treatment over 7 days, rhinosinusitis sum scores decreased statistically significantly (p < 0.001) by - 64.25%, which was comparable to that achieved with Xylometazoline-containing decongesting nasal spray (- 67.60%). No side effects were observed during treatment with Ectoin Rhinitis Spray, whereas treatment with Xylometazoline-containing nasal spray resulted in nasal mucosa dryness. Concomitant treatment with both products diminished the development of nasal dryness and required fewer applications of Xylometazoline-containing nasal spray.
Ectoin Rhinitis Spray is an effective, natural treatment option for acute rhinosinusitis, which may be used as monotherapy or as add-on treatment with a Xylometazoline-containing nasal spray. The concomitant use of Ectoin Rhinitis Spray might reduce the needed dose of decongestant nasal spray and counteract bothersome side effects such as dry nasal mucosa.
The current study was registered in the ClinicalTrials.gov database under the identifier: NCT03693976 (date of registration: Oct 3, 2018).
急性鼻-鼻窦炎的症状缓解通常可通过使用鼻腔减充血剂来实现。本观察性研究旨在比较依他盐水鼻腔喷雾与含有羟甲唑啉的减充血鼻腔喷雾剂治疗急性鼻-鼻窦炎的疗效和安全性，或评估二者联合应用的效果。
患有急性鼻-鼻窦炎的患者分别使用依他盐水鼻腔喷雾、羟甲唑啉鼻腔喷雾剂或两者联合应用。通过鼻内镜评估鼻-鼻窦炎症状，并确定鼻黏膜水肿和鼻腔内红肿情况。基于经过验证的 SNOT（鼻-鼻窦炎生活质量调查问卷）问卷的患者日记评估了鼻-鼻窦炎参数随时间的变化以及疾病对生活质量的影响。治疗结束后，研究者和患者评估了疗效和耐受性。
依他盐水鼻腔喷雾可减轻鼻塞、鼻分泌物、面部疼痛/头痛和嗅觉/味觉障碍等常见鼻-鼻窦炎症状。在 7 天的治疗过程中，鼻-鼻窦炎总评分显著降低（p < 0.001），降幅为-64.25%，与含有羟甲唑啉的减充血鼻腔喷雾剂（-67.60%）相当。使用依他盐水鼻腔喷雾治疗时未观察到任何副作用，而使用含有羟甲唑啉的鼻腔喷雾剂治疗时则出现鼻黏膜干燥。两种药物联合使用可减少鼻干燥的发生，且羟甲唑啉鼻腔喷雾剂的应用次数也更少。
依他盐水鼻腔喷雾是治疗急性鼻-鼻窦炎的一种有效、天然的治疗选择，可单独使用或与含有羟甲唑啉的鼻腔喷雾剂联合使用。依他盐水鼻腔喷雾与含有羟甲唑啉的鼻腔喷雾剂联合使用可能减少减充血鼻腔喷雾剂的所需剂量，并减轻鼻黏膜干燥等烦人的副作用。
本研究已在 ClinicalTrials.gov 数据库中注册，注册号为 NCT03693976（注册日期：2018 年 10 月 3 日）。
