Dekhuijzen P N R
Universitair Medisch Centrum St Radboud, afd. Longziekten (454), Postbus 9101, 6500 HB Nijmegen.
Ned Tijdschr Geneeskd. 2006 Apr 22;150(16):889-91.
How safe is the use of long-acting beta2-adrenergic agonists in the treatment of asthma? Recently, several warnings have been issued by the US Food and Drug Administration and the World Health Organization concerning the safety of long-acting beta2-adrenergic agonists in the treatment of patients with asthma. These warnings were based on data from the 'Salmeterol multicenter asthma research trial' (SMART) published in January 2006. This randomized, placebo-controlled trial studied the effects of the addition of either salmeterol or placebo to the usual medication regime, with respiratory-related deaths and life-threatening events as primary endpoints. There were no significant differences between treatments for these conditions. There were small, but statistically significant increases in respiratory-related and asthma-related deaths, and combined asthma-related deaths, as well as life-threatening events in the total population receiving salmeterol. It is not clear whether the concomitant use of inhaled corticosteroids prevents an increased risk of such events. If asthma is not well-controlled by moderate doses of inhaled steroids, the respiratory and non-respiratory factors that elicit asthma attacks should be reduced and special attention paid to therapy compliance and the correct use ofinhalers. Treatment options including intensifying anti-inflammatory treatment by the use of inhaled corticosteroids which give increased peripheral lung deposition or the addition ofleukotriene receptor antagonists should also be considered before prescribing long-acting beta2-adrenergic agonists.
长效β2肾上腺素能激动剂用于治疗哮喘的安全性如何?最近,美国食品药品监督管理局和世界卫生组织就长效β2肾上腺素能激动剂治疗哮喘患者的安全性发布了多项警告。这些警告基于2006年1月发表的“沙美特罗多中心哮喘研究试验”(SMART)的数据。这项随机、安慰剂对照试验研究了在常规用药方案中添加沙美特罗或安慰剂的效果,将与呼吸相关的死亡和危及生命的事件作为主要终点。在这些情况的治疗之间没有显著差异。在接受沙美特罗的总体人群中,与呼吸相关和哮喘相关的死亡、合并的哮喘相关死亡以及危及生命的事件有小幅但具有统计学意义的增加。尚不清楚吸入性糖皮质激素的同时使用是否能预防此类事件风险的增加。如果中剂量吸入性糖皮质激素不能很好地控制哮喘,应减少引发哮喘发作的呼吸和非呼吸因素,并特别注意治疗依从性和吸入器的正确使用。在开长效β2肾上腺素能激动剂之前,还应考虑包括使用能增加外周肺沉积的吸入性糖皮质激素强化抗炎治疗或添加白三烯受体拮抗剂在内的治疗选择。