Division of Pharmacy Practice and Administrative Sciences, James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA.
Division of Pharmacy Practice & Administrative Sciences, James L. Winkle College of Pharmacy, and Carl H. Lindner College of Business, University of Cincinnati, Cincinnati, OH, USA.
Ther Adv Drug Saf. 2013 Dec;4(6):254-63. doi: 10.1177/2042098613504124.
The introduction of long-acting beta agonists (LABAs) was considered a major advance in bronchodilator therapy for adult, as well as pediatric, patients with asthma. However, the use of LABAs has raised safety concerns, especially the potential for severe asthma exacerbations (SAEs) resulting in hospitalizations or even death. Meanwhile, the use of inhaled corticosteroids (ICSs), a cornerstone in the treatment of mild-to-severe persistent asthma, has been associated with growth suppression in children. The purpose of this review was to identify and discuss the major published safety studies surrounding LABA, ICS, and combined LABA/ICS usage in children. By way of a critical search for influential published clinical trials, meta-analyses, and observational studies, six studies relevant to the safety of LABA monotherapy, seven studies relevant to ICS monotherapy, and four studies on the subject of LABA/ICS combination usage were identified and reviewed. Based on the reviewed literature, the controversy surrounding these anti-asthma medications was clearly exposed. On the one hand, there is some evidence that LABA monotherapy may be associated with SAEs and asthma-related death, while ICS monotherapy may be associated with a higher risk of growth suppression. On the other hand, the concurrent use of a LABA with an ICS has been associated with positive outcomes including symptom reduction and reduced rate and severity of exacerbations. Further clinical research is warranted and has been called for by the US Food and Drug Administration.
长效β 受体激动剂(LABAs)的引入被认为是成人和儿童哮喘患者支气管扩张剂治疗的重大进展。然而,LABA 的使用引起了安全方面的关注,特别是可能导致严重哮喘恶化(SAEs)从而导致住院甚至死亡。同时,吸入皮质类固醇(ICSs)作为轻度至重度持续性哮喘治疗的基石,与儿童生长抑制有关。本综述的目的是确定并讨论围绕 LABA、ICS 和联合 LABA/ICS 在儿童中的使用的主要已发表的安全性研究。通过对有影响力的已发表临床试验、荟萃分析和观察性研究进行批判性搜索,确定并回顾了六项关于 LABA 单药治疗安全性的研究、七项关于 ICS 单药治疗安全性的研究以及四项关于 LABA/ICS 联合使用安全性的研究。基于已审查的文献,这些抗哮喘药物的争议显然暴露出来。一方面,有一些证据表明 LABA 单药治疗可能与 SAE 和哮喘相关死亡有关,而 ICS 单药治疗可能与生长抑制的风险增加有关。另一方面,LABA 与 ICS 的联合使用与症状减轻以及减少恶化的发生率和严重程度等积极结果相关。美国食品和药物管理局呼吁进行进一步的临床研究。