短期鼻用减充血剂作为鼻内糖皮质激素的桥接治疗用于持续性变应性鼻炎患儿:一项随机对照试验。
Short-term nasal decongestant as bridge therapy with intranasal corticosteroids in children with persistent allergic rhinitis: A randomized controlled trial.
文献信息
| PMID | 42843159 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Necmi Can Yüksel |
| 作者单位 | Pediatric Allergy Department, S.B.Ü Dr. Behçet Uz Children's Hospital, İzmir, Türkiye. Electronic address: dr.necmican@gmail.com. |
| 期刊 | International journal of pediatric otorhinolaryngology |
| SCI 分区 | Q2 |
| IF | 1.7 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 鼻科 |
中文摘要
背景: 鼻内糖皮质激素(INS)是儿童变应性鼻炎(AR)的一线治疗,但其起效延迟可能影响早期依从性。我们评估了在持续性AR患儿中,在INS基础上加用5天局部减充血剂“桥接”治疗的效果。
方法: 在这项前瞻性、开放标签、单中心随机试验中,76名4-17岁中重度持续性AR患儿接受INS单药治疗或INS联合羟甲唑啉治疗最初五天;71名完成随访(n=30和n=41)。在基线和第4周评估总鼻症状评分(TNSS)、峰值鼻吸气流量(PNIF)、儿童鼻结膜炎生活质量问卷(PRQLQ)和鼻一氧化氮(nNO;亚组n=17)。在1个月时使用药物依从性报告量表(MARS)评估依从性。
结果: 两组从基线至第4周均显示TNSS、PNIF和PRQLQ改善。联合组显示更大的TNSS降低(2.9±1.0 vs 1.5±1.3分;p<0.001)、更大的PNIF增加(34.6±16.7 vs 12.8±14.5 L/min;p<0.001)、更大的PRQLQ改善(18.0±9.1 vs 5.3±7.3分;p<0.001)以及更高的MARS评分(22.8±2.3 vs 19.7±2.2;p<0.001)。在探索性nNO亚组中,联合治疗的平均降低更大(212.8 vs 87.8 ppb;p=0.030)。没有参与者报告使用超过五天、反跳性鼻塞或治疗相关不良事件。
结论: 在INS基础上加用5天羟甲唑啉桥接治疗与第4周症状、鼻气流和生活质量更大改善以及更高药物依从性相关。nNO发现是探索性的。
试验注册: ClinicalTrials.gov(NCT07593898;回顾性注册)。
英文摘要
BACKGROUND: Intranasal corticosteroids (INS) are first-line therapy for pediatric allergic rhinitis (AR), but their delayed onset may undermine early adherence. We evaluated a 5-day topical decongestant "bridge" added to INS in children with persistent AR.
METHODS: In this prospective, open-label, single-center randomized trial, 76 children aged 4-17 years with moderate-to-severe persistent AR received INS monotherapy or INS plus oxymetazoline during the first five treatment days; 71 completed follow-up (n = 30 and n = 41). Total Nasal Symptom Score (TNSS), peak nasal inspiratory flow (PNIF), Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) and nasal nitric oxide (nNO; subgroup n = 17) were assessed at baseline and Week 4. Adherence was assessed at Month 1 using the Medication Adherence Report Scale (MARS).
RESULTS: Both groups showed improvements in TNSS, PNIF, and PRQLQ from baseline to Week 4. The combined group showed greater TNSS reduction (2.9 ± 1.0 vs 1.5 ± 1.3 points; p < 0.001), greater PNIF increase (34.6 ± 16.7 vs 12.8 ± 14.5 L/min; p < 0.001), greater PRQLQ improvement (18.0 ± 9.1 vs 5.3 ± 7.3 points; p < 0.001), and higher MARS scores (22.8 ± 2.3 vs 19.7 ± 2.2; p < 0.001). In the exploratory nNO subgroup, mean reduction was greater with combined therapy (212.8 vs 87.8 ppb; p = 0.030). No participant reported use beyond five days, rebound congestion, or a treatment-related adverse event.
CONCLUSION: A 5-day oxymetazoline bridge added to INS was associated with greater improvements in symptoms, nasal airflow, and quality of life at Week 4, together with higher medication adherence. The nNO findings are exploratory.
TRIAL REGISTRATION: ClinicalTrials.gov (NCT07593898; retrospectively registered).