Berger William E
Allergy & Asthma Associates of Southern California, Mission Viejo, California 92691-6410, USA.
Drugs. 2005;65(14):1973-89. doi: 10.2165/00003495-200565140-00005.
On the basis of the well recognised role of inflammation in the pathogenesis of asthma, anti-inflammatory therapy, in the form of inhaled corticosteroids, has become the mainstay of treatment in patients with persistent asthma. Budesonide inhalation suspension (BIS) is a nonhalogenated corticosteroid with a high ratio of local anti-inflammatory activity to systemic activity. Furthermore, BIS is approved in >70 countries for the maintenance treatment of bronchial asthma in both paediatric and adult patients (approval is limited to paediatric patients in the US and France).Randomised, double-blind, placebo-controlled trials conducted in >1000 children have demonstrated the efficacy of BIS in children with persistent asthma of varying degrees of severity. In children frequently hospitalised with uncontrolled asthma, initiation of BIS therapy can reduce the need for emergency intervention. Moreover, limited data suggest that BIS is effective for the treatment of acute exacerbations of asthma in children and may reduce the need for short courses of oral corticosteroids.BIS is well tolerated in children, with an adverse event profile similar to that of placebo, and no clinically relevant changes in adrenal function have been demonstrated during the course of short- and long-term (1-year) studies. Small but statistically significant reductions in growth velocity have been demonstrated with BIS over 1 year of treatment. However, available evidence suggests that growth effects are transient in children receiving budesonide and that these children eventually achieve full adult height.
基于炎症在哮喘发病机制中公认的作用,以吸入性糖皮质激素形式进行的抗炎治疗已成为持续性哮喘患者治疗的主要手段。布地奈德吸入混悬液(BIS)是一种非卤化糖皮质激素,局部抗炎活性与全身活性之比很高。此外,BIS在70多个国家被批准用于儿童和成人支气管哮喘的维持治疗(在美国和法国,批准仅限于儿科患者)。在1000多名儿童中进行的随机、双盲、安慰剂对照试验证明了BIS对不同严重程度的持续性哮喘儿童有效。在因哮喘控制不佳而频繁住院的儿童中,开始使用BIS治疗可减少紧急干预的需求。此外,有限的数据表明,BIS对治疗儿童哮喘急性加重有效,且可能减少短期口服糖皮质激素的需求。BIS在儿童中耐受性良好,不良事件谱与安慰剂相似,在短期和长期(1年)研究过程中未发现肾上腺功能有临床相关变化。在1年的治疗中,BIS已被证明会使生长速度出现小幅但具有统计学意义的下降。然而,现有证据表明,接受布地奈德治疗的儿童生长影响是短暂的,这些儿童最终能达到成人的完整身高。