National Jewish Health, Denver, CO80206, USA.
J Allergy Clin Immunol. 2010 Feb;125(2):390-396.e8. doi: 10.1016/j.jaci.2009.11.036.
Concerns exist that regular long-acting beta(2)-adrenergic agonist (LABA) therapy may increase the risk of serious asthma-related events.
To assess risks of formoterol-containing versus non-LABA treatment by using a large asthma database.
This analysis included all blind, parallel-arm, randomized, active-controlled and/or placebo-controlled AstraZeneca-sponsored asthma studies with formoterol-containing and non-LABA comparator arms. Serious adverse events were assessed for inclusion in all-cause death, asthma-related death, asthma-related intubation, and asthma-related hospitalization categories by using blind adjudication. Data were combined across trials; relative risk (RR) was assessed by using Mantel-Haenszel methods.
Data were from 13,542 formoterol-randomized and 9968 non-LABA patients 4 years or older (42 trials), of whom 93% and 89%, respectively, received inhaled corticosteroid as part of randomized treatment or allowed medication. Incidence of all-cause death was low (n=3 and n=4, respectively), with numerically lower all-cause deaths/1000 patient-treatment years in the formoterol-treated group (0.53) versus the non-LABA group (0.82) (RR, 0.64; 95% confidence interval [CI], 0.14-2.92). No asthma-related deaths and 1 asthma-related intubation (formoterol-treated group) occurred. Asthma-related hospitalizations/1000 patient-treatment years were lower numerically in the formoterol-treated group (12.1) versus the non-LABA group (16.4) (RR, 0.73; 95% CI, 0.54-1.01), with fewer study discontinuations in the formoterol-treated group (12.7% vs 15.4%, respectively; RR, 0.79; 95% CI, 0.74-0.85). Relative to non-LABA, increasing daily formoterol dose (>/=4.5, 9, 18, 36 mug) did not increase the rate or incidence of asthma-related hospitalization.
No evidence of increased risk of asthma-related hospitalization, no asthma-related deaths, and a low incidence of all-cause death and asthma-related intubation were seen with formoterol-containing versus non-LABA treatment.
人们担心常规长效β2-激动剂（LABA）治疗可能会增加严重哮喘相关事件的风险。
使用大型哮喘数据库评估福莫特罗与非 LABA 治疗的风险。
这项分析包括所有盲法、平行臂、随机、活性对照和/或安慰剂对照的阿斯利康赞助的含有福莫特罗和非 LABA 对照臂的哮喘研究。通过盲法裁决，将所有原因死亡、哮喘相关死亡、哮喘相关插管和哮喘相关住院的严重不良事件纳入评估。通过合并试验数据，使用 Mantel-Haenszel 方法评估相对风险（RR）。
数据来自 13542 名接受福莫特罗随机治疗和 9968 名非 LABA 治疗的 4 岁或以上患者（42 项试验），其中 93%和 89%分别接受了吸入皮质类固醇作为随机治疗的一部分或允许使用药物。所有原因死亡的发生率较低（分别为 n=3 和 n=4），福莫特罗治疗组的所有原因死亡/1000 患者治疗年数略低（0.53），而非 LABA 组（0.82）（RR，0.64；95%置信区间[CI]，0.14-2.92）。没有哮喘相关死亡和 1 例哮喘相关插管（福莫特罗治疗组）。福莫特罗治疗组的哮喘相关住院/1000 患者治疗年数略低（12.1），而非 LABA 组（16.4）（RR，0.73；95%CI，0.54-1.01），福莫特罗治疗组的研究中止率较低（分别为 12.7%和 15.4%；RR，0.79；95%CI，0.74-0.85）。与非 LABA 相比，福莫特罗日剂量增加（>/=4.5、9、18、36 mug）并没有增加哮喘相关住院的发生率或风险。
与非 LABA 相比，福莫特罗治疗并未增加哮喘相关住院、哮喘相关死亡的风险，且全因死亡率和哮喘相关插管的发生率较低。
