Salpeter Shelley R, Buckley Nicholas S, Ormiston Thomas M, Salpeter Edwin E
Santa Clara Valley Medical Center, San Jose, California 95128, USA.
Ann Intern Med. 2006 Jun 20;144(12):904-12. doi: 10.7326/0003-4819-144-12-200606200-00126. Epub 2006 Jun 5.
Long-acting beta-agonists may increase the risk for fatal and nonfatal asthma exacerbations.
To assess the risk for severe, life-threatening, or fatal asthma exacerbations associated with long-acting beta-agonists.
English- and non-English-language searches of MEDLINE, EMBASE, and Cochrane databases; the U.S. Food and Drug Administration Web site; and references of selected reviews through December 2005.
Randomized, placebo-controlled trials that lasted at least 3 months and evaluated long-acting beta-agonist use in patients with asthma. All trials allowed the use of as-needed short-acting beta-agonists.
Outcomes measured were Peto odds ratio (OR) and risk difference of severe exacerbations requiring hospitalization, life-threatening exacerbations requiring intubation and ventilation, and asthma-related deaths. The OR for asthma-related deaths was obtained from the Salmeterol Multi-center Asthma Research Trial (SMART).
Pooled results from 19 trials with 33 826 participants found that long-acting beta-agonists increased exacerbations requiring hospitalization (OR, 2.6 [95% CI, 1.6 to 4.3]) and life-threatening exacerbations (OR, 1.8 [CI, 1.1 to 2.9]) compared with placebo. Hospitalizations were statistically significantly increased with salmeterol (OR, 1.7 [CI, 1.1 to 2.7]) and formoterol (OR, 3.2 [CI, 1.7 to 6.0]) and in children (OR, 3.9 [CI, 1.7 to 8.8]) and adults (OR, 2.0 [CI, 1.1 to 3.9]). The absolute increase in hospitalization was 0.7% (CI, 0.1% to 1.3%) over 6 months. The risk for asthma-related deaths was increased (OR, 3.5 [CI, 1.3 to 9.3]), with a pooled risk difference of 0.07% (CI, 0.01% to 0.1%).
The small number of deaths limited the reliability in assessing this risk, and 28 studies did not report information on the outcomes of interest.
Long-acting beta-agonists have been shown to increase severe and life-threatening asthma exacerbations, as well as asthma-related deaths.
长效β受体激动剂可能会增加致命和非致命性哮喘加重的风险。
评估与长效β受体激动剂相关的严重、危及生命或致命性哮喘加重的风险。
对MEDLINE、EMBASE和Cochrane数据库进行英文和非英文检索；美国食品药品监督管理局网站；以及截至2005年12月选定综述的参考文献。
持续至少3个月且评估哮喘患者使用长效β受体激动剂的随机、安慰剂对照试验。所有试验均允许使用按需短效β受体激动剂。
测量的结局指标为Peto比值比（OR）以及需要住院治疗的严重加重、需要插管和通气的危及生命加重以及哮喘相关死亡的风险差异。哮喘相关死亡的OR值来自沙美特罗多中心哮喘研究试验（SMART）。
19项试验共33826名参与者的汇总结果发现，与安慰剂相比，长效β受体激动剂增加了需要住院治疗的加重（OR，2.6 [95%CI，1.6至4.3]）和危及生命的加重（OR，1.8 [CI，1.1至2.9]）。沙美特罗（OR，1.7 [CI，1.1至2.7]）和福莫特罗（OR，3.2 [CI，1.7至6.0]）以及儿童（OR，3.9 [CI，1.7至8.8]）和成人（OR，2.0 [CI，1.1至3.9]）的住院率在统计学上显著增加。6个月内住院率的绝对增加为0.7%（CI，0.1%至1.3%）。哮喘相关死亡风险增加（OR，3.5 [CI，1.3至9.3]），汇总风险差异为0.07%（CI，0.01%至0.1%）。
死亡人数较少限制了评估此风险的可靠性，且28项研究未报告有关感兴趣结局的信息。
长效β受体激动剂已被证明会增加严重和危及生命的哮喘加重以及哮喘相关死亡。
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