Department of Respiratory Medicine, The Queen Elizabeth Hospital, Woodville, SA, Australia.
Drugs. 2011 Nov 12;71(16):2091-7. doi: 10.2165/11596260-000000000-00000.
Large surveillance studies or phase IV clinical studies of long-acting β-agonists (LABA) compared with placebo in asthma patients using variable (from nil to regular) doses of inhaled corticosteroids (ICS) have raised the issue of mortality risk in patients with asthma taking regular LABA. There have been a number of meta-analyses and systematic reviews that have examined the risk of LABA in asthma patients, and the general conclusion is that LABA added to ICS reduces asthma-related hospitalizations compared with ICS alone and there is no statistical increase in mortality. However, LABA without ICS do increase mortality risk in asthma. All reviews and analyses show a greater number of LABA deaths, but not all are statistically significant. A recent meta-analysis found LABA with concomitant ICS had a higher mortality rate in asthma than ICS alone. The flaw in the study is the higher doses of ICS in the control arms, but the implicit message remains: the essential need for enough ICS to control airway inflammation. We suggest that the pragmatic solution is to have LABA only available in the same device as ICS for asthma treatment. We do not think that a study comparing the safety of LABA plus ICS versus ICS alone in asthma is necessary. If such a study is conducted, the measurement of morbidity from increased doses of ICS is an essential design consideration. Furthermore, the critical focus in asthma management should not be forgotten - education of health professionals and the community of the critical role of ICS, and the need for good communication between health professionals and the asthma patient to facilitate good asthma control. The same arguments apply to the asthma-with-chronic obstructive pulmonary disease overlap syndrome in older patients. There is an urgent need to provide medical practitioners with the capability to diagnose the overlap syndrome.
在使用可变剂量(从无到常规)吸入皮质类固醇(ICS)的哮喘患者中,长效β-激动剂(LABA)与安慰剂相比的大型监测研究或 IV 期临床研究提出了接受常规 LABA 治疗的哮喘患者的死亡风险问题。已经有许多荟萃分析和系统评价研究了 LABA 在哮喘患者中的风险,一般结论是 LABA 联合 ICS 可降低哮喘相关住院率,与单独使用 ICS 相比,死亡率没有统计学增加。然而,不联合 ICS 的 LABA 确实会增加哮喘患者的死亡风险。所有的综述和分析都显示 LABA 死亡人数更多,但并非所有都具有统计学意义。最近的一项荟萃分析发现,与单独使用 ICS 相比,LABA 联合 ICS 治疗哮喘的死亡率更高。该研究的缺陷在于对照组中 ICS 的剂量更高,但隐含的信息仍然存在:控制气道炎症需要足够的 ICS。我们建议,实际解决办法是将 LABA 仅与用于哮喘治疗的 ICS 置于同一设备中。我们认为,没有必要进行比较 LABA 联合 ICS 与单独使用 ICS 在哮喘中的安全性的研究。如果进行这样的研究,就需要考虑增加 ICS 剂量对发病率的影响,这是一个重要的设计考虑因素。此外,在哮喘管理中,不应忘记关键的重点 - 教育卫生专业人员和社区 ICS 的关键作用,以及卫生专业人员与哮喘患者之间进行良好沟通以促进良好哮喘控制的必要性。同样的论点也适用于老年患者中哮喘与慢性阻塞性肺疾病重叠综合征。迫切需要为医务人员提供诊断重叠综合征的能力。