Long-acting β2-agonists in asthma -: Not so SMART?
Long-acting β2-agonists in asthma -: Not so SMART?
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DOI：
10.2165/00002018-200629080-00002
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发表时间：
2006-01-01
期刊：
影响因子：
4.2
通讯作者：
Lipworth, Brian J.
中科院分区：
文献类型：
--
作者：
Currie, Graeme P.;Lee, Daniel K. C.;Lipworth, Brian J.
哮喘是一种世界性的慢性疾病，其特征在于气道炎症和高反应性，其导致间歇性气流阻塞和随后的症状感知和恶化。吸入性皮质类固醇是预防哮喘控制不佳相关的短期和长期并发症的基本组成部分。然而，尽管接受低至中等剂量的吸入性皮质类固醇（400-800 μ g/天的倍氯米松或等效物），许多个体经历持续的症状和恶化。在这些有症状的哮喘患者中，指南提倡启动长效β 2-肾上腺素受体激动剂（LABA）作为额外的二线控制治疗。（沙美特罗多中心哮喘研究试验）研究旨在比较添加沙美特罗42 μ g（前致动器），每天两次，安慰剂超过28周，在一个随机，双盲，平行组的方式，目的是招募60 000哮喘患者。然而，这项研究被提前停止，因为初步数据显示，死亡率增加与经常使用沙美特罗。此外，在非裔美国人中观察到了与哮喘相关的死亡率、哮喘相关的死亡率和危及生命的事件，这些非裔美国人占研究人群的18%。这反过来又促使美国FDA宣布关于含有LABA的吸入器的重要安全信息，并建议制作新的标签，概述与定期使用有关的“哮喘相关死亡的小但重大风险”。这项循证综述讨论了SMART的数据，并强调了在持续性哮喘中定期使用LABA的潜在重要缺点。
Asthma is a worldwide chronic disorder that is characterised by airway inflammation and hyper-responsiveness, which results in intermittent airflow obstruction and subsequent perception of symptoms and exacerbations. Inhaled corticosteroids are a fundamental component in the prevention of the short- and long-term complications associated with inadequately controlled asthma. However, many individuals experience persistent symptoms and exacerbations despite receiving low-to-medium doses of an inhaled corticosteroid (400-800 mu g/day of beclometasone or equivalent). In these symptomatic asthmatic patients, guidelines advocate the initiation of a long-acting beta 2-adrenoceptor agonist (LABA) as additional second-line controller therapy.The recent SMART (Salmeterol Multi-centre Asthma Research Trial) study was designed to compare the effects of add-on salmeterol 42 mu g (ex-actuator) twice daily with placebo over 28 weeks in a randomised, double-blind, parallel-group fashion, with the intention to enrol 60 000 asthmatic patients. However, the study was halted prematurely because preliminary data revealed an increased mortality associated with regular use of salmeterol. Moreover, concerning rates of respiratory-related deaths, asthma-related deaths and life-threatening events were observed among African Americans, who constituted up to 18% of the study population. This in turn prompted the US FDA to announce important safety information regarding inhalers containing LABAs and advise that new labelling be produced outlining the "small but significant risk in asthma-related deaths" associated with their regular use. This evidence-based review discusses the data from SMART and highlights potentially important drawbacks with regular use of LABAs in persistent asthma.