丙酸氟替卡松-氮䓬斯汀鼻喷雾剂治疗中重度非变应性及常年性变应性鼻炎的real-world疗效
Real-world effectiveness of fluticasone propionate-azelastine nasal spray in moderate-to-severe nonallergic and perennial allergic rhinitis.
文献信息
| PMID | 42741242 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Piyaporn Chokevittaya |
| 作者单位 | Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. |
| 期刊 | The World Allergy Organization journal |
| SCI 分区 | Q2 |
| IF | 4.8 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 鼻科 |
中文摘要
背景： 尽管复方鼻内糖皮质激素-抗组胺喷雾剂已被批准用于变应性鼻炎，但支持其在非变应性鼻炎（NAR）中有效性的证据仍然有限。
目的： 比较丙酸氟替卡松-氮䓬斯汀（FP-Aze）治疗NAR与常年性变应性鼻炎（PAR）的治疗反应。
方法： 这项前瞻性观察性真实世界研究纳入了患有中重度PAR或NAR的成人。参与者接受FP-Aze鼻喷雾剂（50/137 μg），每侧鼻孔1喷，每日两次，共4周。主要终点为鼻炎视觉模拟量表（VAS，范围0至100 mm）较基线的变化。评估NAR的治疗有效性采用非劣效性检验，相对于PAR的预设界值为VAS 23 mm。次要结局包括非鼻部症状和生活质量（QoL）的评估。
结果： 纳入中重度PAR患者（n = 108）和NAR患者（n = 62）。FP-Aze在两组中均显著改善鼻部症状。在第4周，PAR组鼻炎VAS的校正平均变化（95% CI）为-52.20 mm（-57.37，-47.03），NAR组为-48.59 mm（-55.64，-41.54）。两组平均变化差异为3.61 mm（-5.58，12.79），符合非劣效性标准。两组生活质量均显著改善，组间差异无统计学意义。排除按需使用口服抗组胺药患者的敏感性分析结果一致。治疗耐受性良好，最常见的不良事件为苦味；未观察到严重不良事件。
结论： 在中重度NAR中，FP-Aze在鼻炎VAS方面的有效性不劣于PAR，支持其在该人群中的使用。这些发现有助于填补重要的证据空白，因为支持FP-Aze用于NAR的数据仍然有限。
英文摘要
BACKGROUND: Although combined intranasal corticosteroid-antihistamine sprays are approved for allergic rhinitis, evidence supporting their effectiveness in nonallergic rhinitis (NAR) remains limited.
OBJECTIVE: To compare the treatment response to fluticasone propionate-azelastine (FP-Aze) for treating NAR and perennial allergic rhinitis (PAR).
METHODS: This prospective observational real-world study enrolled adults with moderate-to-severe PAR or NAR. Participants received FP-Aze nasal spray (50/137 μg), 1 spray per nostril twice daily for 4 weeks. The primary endpoint was the change from baseline in the visual analog scale (VAS) for rhinitis, ranging from 0 to 100 mm. Treatment effectiveness in NAR was assessed for noninferiority, with a prespecified margin of 23 mm on the VAS relative to PAR. Secondary outcomes included evaluation of non-nasal symptoms and quality of life (QoL).
RESULTS: Patients with moderate-to-severe PAR (n = 108) and NAR (n = 62) were included. FP-Aze significantly improved nasal symptoms in both groups. At Week 4, adjusted mean changes (95% CI) in VAS for rhinitis were -52.20 mm (-57.37, -47.03) in PAR and -48.59 mm (-55.64, -41.54) in NAR. The between-group difference in mean change was 3.61 mm (-5.58, 12.79), meeting the noninferiority criterion. QoL improved significantly in both groups, with no significant between-group differences. Sensitivity analyses excluding patients who used as-needed oral antihistamines yielded consistent results. Treatment was well tolerated, with a bitter taste as the most commonly reported adverse event; no serious adverse events were observed.
CONCLUSION: The effectiveness of FP-Aze in moderate-to-severe NAR was noninferior to PAR on the VAS for rhinitis, supporting its use in this population. These findings help address an important evidence gap, as data supporting FP-Aze in NAR remain limited.