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Mometasone furoate in children with mild to moderate persistent asthma: a review of the evidence.

机译:糠酸莫米他松用于轻度至中度持续性哮喘的儿童:证据回顾。

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The high prevalence of asthma in pediatric patients underscores the need for effective and safe treatment in this population. Current treatment guidelines recommend inhaled corticosteroids (ICSs) as a preferred treatment for the control of mild to moderate persistent asthma in patients of all ages, including young children. Clinical efficacy, systemic safety, and ease of use are desirable attributes of an ICS used to treat children with persistent asthma. Recently, mometasone furoate administered via a dry powder inhaler (MF-DPI) 110 microg once daily in the evening (delivered dose of 100 microg) was approved by the US FDA for the maintenance treatment of asthma in children 4-11 years of age. Data from the clinical trial program for MF-DPI that establish the efficacy, long-term safety, and absence of systemic effects of the approved dosage in children with mild to moderate persistent asthma are reviewed. These findings indicate that once-daily dosing of MF-DPI in children aged 4-11 years significantly improves lung function and health-related quality of life while reducing rescue medication use and exacerbations despite previous treatment with other ICSs. MF-DPI is also well tolerated in children. Clinical trial results showed that, at the approved dosage, there are no effects on growth velocity or the hypothalamic-pituitary-adrenal axis. Results of pediatric studies are consistent with the clinical development program for adults and adolescents. In addition, once-daily dosing, established safety, and ease of use of MF-DPI may help to improve asthma management by addressing issues that inhibit proper adherence.
机译:小儿哮喘的高患病率突显了对该人群有效和安全治疗的需求。当前的治疗指南建议吸入性糖皮质激素(ICSs)作为控制所有年龄段患者(包括幼儿)中轻度至中度持续性哮喘的首选治疗方法。临床疗效,全身安全性和易用性是用于治疗患有持续性哮喘的儿童的ICS的理想属性。最近,美国FDA批准每天晚上通过干粉吸入器(MF-DPI)110微克糠酸莫米松(分娩剂量为100微克)用于维持4-11岁儿童的哮喘。回顾了MF-DPI临床试验计划中的数据,该数据确定了轻度至中度持续性哮喘患儿的疗效,长期安全性和批准剂量的全身性影响。这些发现表明,尽管先前已接受过其他ICS的治疗,但每天一次给4-11岁儿童使用MF-DPI可以显着改善肺功能和与健康相关的生活质量,同时减少急救药物的使用和恶化。儿童对MF-DPI的耐受性也很好。临床试验结果表明,在批准的剂量下,对生长速度或下丘脑-垂体-肾上腺轴没有影响。儿科研究的结果与成人和青少年的临床开发计划一致。此外,每天一次的给药,确定的安全性和MF-DPI的易用性可能会通过解决抑制适当依从性的问题来帮助改善哮喘管理。

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