Bikhazi Nadim, Light Joshua, Truitt Theodore, Schwartz Michael, Cutler Jeffrey
Ogden Clinic, Ogden, Utah, USA.
Am J Rhinol Allergy. 2014 Jul-Aug;28(4):323-9. doi: 10.2500/ajra.2014.28.4064. Epub 2014 May 12.
The objective of this prospective, multicenter, randomized trial was to evaluate and compare 1-year outcomes from the REMODEL study between office balloon dilation and functional endoscopic sinus surgery (FESS).
Adults with maxillary chronic rhinosinusitis (CRS), including those with anterior ethmoid disease, who failed medical management and were surgical candidates for FESS, underwent either standalone balloon dilation or FESS in a 1:1 randomization scheme and were followed through a minimum of 1 year. Sinonasal symptom improvement was assessed using the validated 20-item Sino-Nasal Outcome Test (SNOT-20) survey. Standardized effect sizes were computed to further assess clinical significance. Ostial patency rate, rhinosinusitis episode frequency, impact of sinus disease on activity and work productivity using the validated Work Productivity and Activity Impairment survey, complications, and revision rate were also compared between the two groups.
Ninety-two patients (50 balloon dilation; 42 FESS) were treated and 89 (96.7%) completed 1-year follow-up. Both groups showed clinically meaningful and statistically significant (p < 0.0001) improvement in mean overall SNOT-20 scores and in all four SNOT-20 subscales. The 1-year mean change in SNOT-20 after balloon dilation (-1.64) was noninferior to FESS (-1.65; p < 0.001). The standardized effect size was large, showing clinically significant improvement for both interventions. Ostial patency was 96.7 and 98.7% after balloon dilation and FESS, respectively, and each group reported significant reductions (p < 0.0001) in rhinosinusitis episodes (mean decrease, 4.2 for balloon dilation and 3.5 for FESS). Overall work productivity and daily activity impairment due to chronic sinusitis were significantly improved (p < 0.001) in both groups. There were no complications and revision surgery rate was 2% in each arm through 1 year.
With 1-year follow-up, standalone balloon dilation is as effective as FESS in the treatment of CRS in patients with maxillary sinus disease with or without anterior ethmoid disease who failed medical therapy and met the criteria for medically necessary FESS.
这项前瞻性、多中心、随机试验的目的是评估和比较REMODEL研究中门诊球囊扩张术与功能性鼻内镜鼻窦手术（FESS）的1年治疗效果。
患有上颌慢性鼻窦炎（CRS）的成年人，包括伴有筛窦前部疾病且药物治疗无效且符合FESS手术指征的患者，按照1:1随机分组方案，分别接受单纯球囊扩张术或FESS手术，并至少随访1年。使用经过验证的20项鼻鼻窦结局测试（SNOT-20）调查问卷评估鼻鼻窦症状改善情况。计算标准化效应量以进一步评估临床意义。还比较了两组的窦口通畅率、鼻窦炎发作频率、使用经过验证的工作效率和活动障碍调查问卷评估的鼻窦疾病对活动和工作效率的影响、并发症以及翻修率。
92例患者（50例接受球囊扩张术；42例接受FESS手术）接受了治疗，89例（96.7%）完成了1年随访。两组患者的总体SNOT-20平均得分以及所有四个SNOT-20子量表均显示出具有临床意义且在统计学上有显著差异（p<0.0001）的改善。球囊扩张术后SNOT-20的1年平均变化（-1.64）不劣于FESS手术（-1.65；p<0.001）。标准化效应量较大，表明两种干预措施均有显著的临床改善。球囊扩张术和FESS术后窦口通畅率分别为96.7%和98.7%，每组鼻窦炎发作次数均显著减少（p<0.0001）（球囊扩张术平均减少4.2次，FESS手术平均减少3.5次）。两组因慢性鼻窦炎导致的总体工作效率和日常活动障碍均有显著改善（p<0.001）。两组均未出现并发症，1年内每组的翻修手术率均为2%。
经过1年随访，对于药物治疗无效且符合必要FESS标准的伴有或不伴有筛窦前部疾病的上颌窦疾病患者，单纯球囊扩张术在治疗CRS方面与FESS手术效果相当。
