Kovacs Alexander J, Adappa Nithin D, Kuan Edward C
Department of Otolaryngology-Head and Neck Surgery, 8788University of California, Irvine, CA, USA.
Department of Otorhinolaryngology-Head and Neck Surgery, 6572University of Pennsylvania, Philadelphia, PA, USA.
Ear Nose Throat J. 2021 Jun;100(5):309-313. doi: 10.1177/0145561320980194. Epub 2020 Dec 11.
Chronic rhinosinusitis (CRS) is a common sinonasal disorder which results in significant inflammation in the nasal cavity and paranasal sinuses. Topical nasal steroids play an important role in the treatment of CRS. Exhalation delivery system with fluticasone (EDS-FLU) utilizes a patient's forced exhalation to power the delivery of topical steroids to deeper areas of the nasal cavity and paranasal sinuses most affected by CRS. This review focuses on evidence surrounding the safety and efficacy of the EDS-FLU system.
Literature search was conducted of articles investigating the safety and efficacy of EDS-FLU. Relevant efficacy and safety data were examined and summarized from the studies.
The efficacy and safety of EDS-FLU in CRS, both with and without polyps, has been established in open-label and placebo-controlled phase 3 trials. There was significant improvement in the cardinal symptoms of CRS and subjective patient-reported outcomes scores. Additionally, there was objective improvement in sinonasal inflammation as measured by polyp grade. Recent studies have also established significant improvement in health status and general quality of life following treatment using EDS-FLU. Emerging data have also examined patients who have previously had endoscopic sinus surgery and on appropriate medical therapy and noted improvement in polyp burden and overall Lund-Kennedy scores after using EDS-FLU.
Exhalation delivery system with fluticasone demonstrates significant results in both patient-oriented outcomes and objective measures of sinonasal inflammation in patients with CRS with and without polyps. Further research is needed to investigate the long-term outcomes of EDS-FLU and to compare the effects of EDS-FLU with ESS. Exhalation delivery system with fluticasone provides an additional effective treatment modality for patients suffering from CRS.
慢性鼻-鼻窦炎(CRS)是一种常见的鼻窦疾病,可导致鼻腔和鼻窦出现显著炎症。局部鼻用类固醇在CRS的治疗中发挥着重要作用。氟替卡松呼气给药系统(EDS-FLU)利用患者的用力呼气,将局部类固醇输送到受CRS影响最严重的鼻腔和鼻窦深部区域。本综述聚焦于围绕EDS-FLU系统安全性和有效性的证据。
对研究EDS-FLU安全性和有效性的文章进行文献检索。从这些研究中检查并总结相关的有效性和安全性数据。
在开放标签和安慰剂对照的3期试验中,已证实EDS-FLU在伴或不伴息肉的CRS中的有效性和安全性。CRS的主要症状和患者报告的主观结局评分有显著改善。此外,通过息肉分级测量,鼻窦炎症有客观改善。最近的研究还证实,使用EDS-FLU治疗后,健康状况和总体生活质量有显著改善。新出现的数据还研究了先前接受过内窥镜鼻窦手术并接受适当药物治疗的患者,发现使用EDS-FLU后息肉负担和整体Lund-Kennedy评分有所改善。
氟替卡松呼气给药系统在伴或不伴息肉的CRS患者的以患者为导向的结局和鼻窦炎症的客观测量方面均显示出显著效果。需要进一步研究来调查EDS-FLU的长期结局,并比较EDS-FLU与内窥镜鼻窦手术(ESS)的效果。氟替卡松呼气给药系统为患有CRS的患者提供了另一种有效的治疗方式。