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糠酸莫米松治疗轻中度持续性哮喘儿童:证据回顾。

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

机构信息

National Jewish Medical and Research Center, School of Medicine, University of Colorado Health Sciences Center, 1400 Jackson Street, Denver, CO 80206, USA.

出版信息

Paediatr Drugs. 2010 Aug 1;12(4):213-21. doi: 10.2165/11316220-000000000-00000.

Abstract

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.

摘要

儿童哮喘的高发率强调了在该人群中需要有效和安全的治疗。目前的治疗指南建议吸入皮质类固醇(ICSs)作为控制所有年龄段患者(包括幼儿)轻度至中度持续性哮喘的首选治疗方法。临床疗效、全身安全性和使用便利性是用于治疗持续性哮喘儿童的 ICS 的理想特性。最近,美泊利单抗干粉吸入剂(MF-DPI)每天晚上一次给予 110 微克(实际给予剂量为 100 微克),经美国 FDA 批准用于 4-11 岁儿童哮喘的维持治疗。对 MF-DPI 临床试验方案的数据进行了回顾,该方案确定了批准剂量在轻度至中度持续性哮喘儿童中的疗效、长期安全性和无全身作用。这些发现表明,MF-DPI 每日一次剂量可显著改善 4-11 岁儿童的肺功能和健康相关生活质量,同时减少急救药物的使用和恶化,尽管他们之前已经接受了其他 ICS 的治疗。MF-DPI 在儿童中也具有良好的耐受性。临床试验结果表明,在批准剂量下,对生长速度或下丘脑-垂体-肾上腺轴没有影响。儿科研究结果与成人和青少年的临床开发方案一致。此外,MF-DPI 的每日一次剂量、已确定的安全性和使用便利性可能有助于通过解决抑制适当依从性的问题来改善哮喘管理。

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