Wise Sarah K, Adappa Nithin D, Chandra Rakesh K, Davis Greg E, Mahdavinia Mahboobeh, Mahmoud Ramy, Messina John, Palmer James N, Patel Zara M, Peters Anju T, Schlosser Rodney J, Sindwani Raj, Soler Zachary M, White Andrew A
Emory University School of Medicine, Atlanta, Georgia, USA.
Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Int Forum Allergy Rhinol. 2024 Dec;14(12):1892-1903. doi: 10.1002/alr.23434. Epub 2024 Aug 26.
The inability of topical medications to reach sinus cavities is a potential reason for lack of efficacy in chronic rhinosinusitis (CRS). One purpose of endoscopic sinus surgery (ESS) is to enable delivery of medications into the sinus cavities. The exhalation delivery system with fluticasone (EDS-FLU; XHANCE) creates unique biomechanics that enable deposition of intranasal corticosteroid into sinuses and sinus drainage pathways but may have differing efficacy in operated versus unoperated sinuses. Two 24-week randomized trials (ReOpen1/2) evaluated EDS-FLU versus EDS-placebo in patients with CRS, stratified by surgical status.
Surgery-naive (n = 332) and prior-surgery (n = 215) patient groups were analyzed as pooled data from ReOpen1/2. Outcome measures (least-squares mean change from baseline) included combined symptom score (CSS) and congestion score at weeks 4, 8, and 12 and average of percentages of opacified volume (APOV) of ethmoid/maxillary sinuses on CT and Sinonasal Outcome Test 22 (SNOT-22) total score at week 24.
Baseline scores suggested moderate-severe disease: mean CSS = 5.8; APOV = 67.2%. EDS-FLU produced significant improvement versus placebo (p < 0.05): CSS (surgery-naive, -0.68 vs. -1.42; prior ESS, -0.70 vs. -1.87); congestion (surgery-naive, -0.24 vs. -0.59; prior ESS, -0.24 vs. -0.69); and SNOT-22 (surgery-naive, -7.56 vs. -18.30; prior ESS, -10.72 vs. -18.74). Similar results were observed for APOV (p < 0.05). No statistically significant difference was observed between surgery subgroups with either EDS-FLU dose.
EDS-FLU improved symptoms, sinus opacification, and quality of life in patients with CRS with or without prior ESS, suggesting a role for EDS-FLU in both populations.
局部用药无法到达鼻窦腔是慢性鼻-鼻窦炎（CRS）疗效欠佳的一个潜在原因。鼻内镜鼻窦手术（ESS）的目的之一是使药物能够送达鼻窦腔。含氟替卡松的呼气给药系统（EDS-FLU；XHANCE）创造了独特的生物力学机制，可使鼻内皮质类固醇沉积于鼻窦及鼻窦引流通道，但在已手术鼻窦和未手术鼻窦中的疗效可能有所不同。两项为期24周的随机试验（ReOpen1/2）对CRS患者的EDS-FLU与EDS-安慰剂进行了评估，并根据手术状态进行分层。
将未接受过手术的患者组（n = 332）和既往接受过手术的患者组（n = 215）作为ReOpen1/2的汇总数据进行分析。观察指标（相对于基线的最小二乘均值变化）包括第4、8和12周时的综合症状评分（CSS）和鼻塞评分，以及第24周时CT上筛窦/上颌窦的混浊体积百分比平均值（APOV）和鼻窦结局测试22（SNOT-22）总分。
基线评分提示为中重度疾病：平均CSS = 5.8；APOV = 67.2%。与安慰剂相比，EDS-FLU有显著改善（p < 0.05）：CSS（未接受过手术者，-0.68对-1.42；既往接受过ESS者，-0.70对-1.87）；鼻塞（未接受过手术者，-0.24对-0.59；既往接受过ESS者，-0.24对-0.69）；以及SNOT-22（未接受过手术者，-7.56对-18.30；既往接受过ESS者，-10.72对-18.74）。APOV也观察到类似结果（p < 0.05）。在接受不同EDS-FLU剂量的手术亚组之间未观察到统计学上的显著差异。
EDS-FLU改善了有或无既往ESS的CRS患者的症状、鼻窦混浊情况及生活质量，提示EDS-FLU在这两类人群中均有作用。
