Zaffanello Marco, Pietrobelli Angelo, Nosetti Luana, Antoniazzi Franco, Frassoldati Rossella, Piacentini Giorgio
Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University of Verona, 37126 Verona, Italy.
Pediatric Department, Department of Medicine and Technological Innovation, Insubria University, F del Ponte Hospital, 21100 Varese, Italy.
Pharmaceutics. 2025 Apr 30;17(5):588. doi: 10.3390/pharmaceutics17050588.
Paediatric Obstructive Sleep Apnoea (OSA) is characterised by recurrent episodes of upper airway obstruction during sleep, manifesting as snoring, intermittent oxygen desaturation, and frequent nocturnal awakenings. Standard treatments include surgical interventions, pharmacological therapies, intranasal corticosteroids, and oral montelukast. However, significant variability exists across studies regarding dosage and outcome assessment. This literature review systematically evaluated clinical evidence regarding the efficacy and safety of intranasal corticosteroids and oral montelukast for treating sleep-disordered breathing and its primary underlying condition, adenoid hypertrophy, in otherwise healthy children. The MEDLINE (PubMed), Scopus, and Web of Science databases were systematically searched up to 13 February 2025, using tailored search terms combining keywords and synonyms related to paediatric OSA, adenoidal hypertrophy, corticosteroids, montelukast, and randomised controlled trials. Owing to variability in outcome measures, Fisher's method for -value combination was employed to enable a comprehensive comparison of drug effects. Available evidence shows that intranasal corticosteroids (mometasone, beclometasone, budesonide, fluticasone, and flunisolide), either as monotherapy or in combination with other agents, consistently lead to clinical and instrumental improvements in adenoid hypertrophy and related respiratory symptoms, with a generally favourable safety profile. Combining montelukast with intranasal corticosteroids appears to offer superior benefits compared with monotherapy. Nevertheless, the reviewed studies varied widely in dosage, treatment duration, design, and sample size. The reported side effects are mostly mild; however, long-term studies are lacking to establish the complete safety of these treatments in children. Intranasal corticosteroids and oral montelukast effectively and safely manage adenoid hypertrophy and mild-to-moderate OSA symptoms in children. Nonetheless, the heterogeneity of study designs necessitates larger prospective trials with standardised protocols and more extended follow-up periods to draw more robust conclusions. Future studies should aim to stratify treatment outcomes based on OSA severity and duration to tailor therapeutic approaches better.
小儿阻塞性睡眠呼吸暂停（OSA）的特征是睡眠期间上呼吸道反复阻塞，表现为打鼾、间歇性氧饱和度下降和频繁夜间觉醒。标准治疗方法包括手术干预、药物治疗、鼻内皮质类固醇和口服孟鲁司特。然而，不同研究在剂量和疗效评估方面存在显著差异。本综述系统评价了鼻内皮质类固醇和口服孟鲁司特治疗睡眠呼吸障碍及其主要潜在病因腺样体肥大在健康儿童中的疗效和安全性的临床证据。截至2025年2月13日，系统检索了MEDLINE（PubMed）、Scopus和Web of Science数据库，使用了结合与小儿OSA、腺样体肥大、皮质类固醇、孟鲁司特和随机对照试验相关的关键词和同义词的定制检索词。由于结局指标的差异，采用Fisher法进行P值合并，以便全面比较药物效果。现有证据表明，鼻内皮质类固醇（莫米松、倍氯米松、布地奈德、氟替卡松和氟尼缩松），无论是单药治疗还是与其他药物联合使用，均能持续改善腺样体肥大和相关呼吸道症状，且具有总体良好的安全性。与单药治疗相比，孟鲁司特与鼻内皮质类固醇联合使用似乎具有更大的益处。然而，所综述的研究在剂量、治疗持续时间、设计和样本量方面差异很大。报告的副作用大多较轻；然而，缺乏长期研究来确定这些治疗方法在儿童中的完全安全性。鼻内皮质类固醇和口服孟鲁司特能有效且安全地治疗儿童腺样体肥大和轻至中度OSA症状。尽管如此，研究设计的异质性需要进行更大规模的前瞻性试验，采用标准化方案并延长随访期，以得出更可靠的结论。未来的研究应旨在根据OSA的严重程度和持续时间对治疗结果进行分层，以更好地调整治疗方法。
