Department of Otorhinolaryngology, Academic Medical Center, Amsterdam, The Netherlands.
Am J Rhinol Allergy. 2012 Jan-Feb;26(1):36-44. doi: 10.2500/ajra.2012.26.3675.
Fluticasone furoate nasal spray (FFNS) and mometasone furoate nasal spray (MFNS) are well tolerated and more effective than placebo at relieving the symptoms of seasonal and perennial allergic rhinitis. Effects of FFNS on the nasal histology have not been previously reported. This study examines the effects of FFNS and MFNS, administered daily for 1 year, on the nasal mucosa in subjects with perennial allergic rhinitis.
Subjects with perennial allergic rhinitis were randomized 1:1 to q.d., open-label treatment with FFNS, 110 μg, or MFNS, 200 μg, for 1 year. These groups and a healthy control group that did not receive study medication underwent nasal biopsies at baseline and 12 months.
The nasal biopsy population comprised 96 participants (37 using FFNS, 42 using MFNS, and 17 healthy controls). Epithelial thickness did not change appreciably from baseline to week 52 in any of the groups and mean change from baseline did not differ between FFNS and MFNS (least square mean difference, -0.001 mm, 95% confidence interval, -0.007, 0.006). Although not tested for significance, improvements over baseline were observed in epithelial histology in the FFNS group with more epithelium including intact columnar and ciliated epithelial cells. No appreciable change in the percentage of goblet cells was established. FFNS and MFNS were associated with decreases in epithelial and subepithelial nasal mucosal eosinophils and basophils from baseline to week 52. The percentage of subjects with no inflammatory cells at week 52 was 49 and 33% for eosinophils and 46 and 24% for basophils, for FFNS and MFNS, respectively.
Yearlong therapy with either FFNS or MFNS showed no changes in epithelial thickness or the percentage of goblet cells as well as a reduction in inflammatory cell infiltrate. FFNS was associated with improvements in epithelial histology. These data support the long-term safety of FFNS in subjects with perennial allergic rhinitis.
氟替卡松糠酸酯鼻喷雾剂（FFNS）和糠酸莫米松鼻喷雾剂（MFNS）在缓解季节性和常年性变应性鼻炎症状方面的耐受性良好，且比安慰剂更有效。FFNS 对鼻组织学的影响以前尚未报道过。本研究检测了 FFNS 和 MFNS 每日治疗 1 年对常年性变应性鼻炎患者鼻黏膜的影响。
将 96 例常年性变应性鼻炎患者按 1:1 比例随机分为每日 1 次、开放标签的 FFNS（110μg）或 MFNS（200μg）治疗组，治疗 1 年。这些组和未接受研究药物的健康对照组在基线和 12 个月时进行鼻活检。
鼻活检人群包括 96 例患者（37 例使用 FFNS，42 例使用 MFNS，17 例健康对照者）。在任何一组中，上皮厚度从基线到第 52 周都没有明显变化，FFNS 和 MFNS 之间的平均变化从基线也没有差异（最小二乘均数差值，-0.001mm，95%置信区间，-0.007，0.006）。尽管未进行统计学检验，但 FFNS 组中上皮组织学观察到了改善，表现为更多的包括完整柱状和有纤毛的上皮细胞在内的上皮。没有建立起杯状细胞百分比的明显变化。FFNS 和 MFNS 与从基线到第 52 周上皮和黏膜下鼻组织嗜酸粒细胞和嗜碱性粒细胞的减少相关。在第 52 周时无炎症细胞的患者比例分别为 49%和 33%（嗜酸粒细胞）和 46%和 24%（嗜碱性粒细胞），FFNS 和 MFNS 分别为 49%和 33%（嗜酸粒细胞）和 46%和 24%（嗜碱性粒细胞）。
FFNS 或 MFNS 长达 1 年的治疗并未引起上皮厚度或杯状细胞百分比的变化，同时减少了炎症细胞浸润。FFNS 与上皮组织学的改善有关。这些数据支持 FFNS 在常年性变应性鼻炎患者中的长期安全性。
