福莫特罗的致死风险：系统性综述和荟萃分析
2009/12/15
研究显示，长效β受体激动剂（LABA）可能增加哮喘患者的死亡风险。为此，本文对其进行系统性综述。检索对象为AstraZeneca 福莫特罗临床试验安全性数据库和Novartis 食品药品管理局福莫特罗简报。选取研究时间≥4周、比较福莫特罗与其它非LABA药物治疗哮喘的随机对照临床研究，对全因死亡率和哮喘死亡率进行荟萃分析。
结果采用简单列联表、Peto’s 一步法和Bayesian 分析。 在62项研究共包括49,327例受试人群中，发生42例死亡病例（9例死于哮喘）。简单列联表显示，采用福莫特罗治疗患者的全因死亡风险OR为1.1 (95% CI 0.6-2.2)，而哮喘死亡风险的OR为2.7 (95% CI 0.5-26.7)。对治疗采用“随机”和“暴露”分类后，运用其它方法进行分析也具有类似的风险估计值，只是可信区间较大。
我们认为，目前福莫特罗增加死亡风险的证据不足。然而哮喘死亡风险的点估计值增加2～3.2倍不能被认为是某些情况下LABA使用能增加哮喘死亡风险的证据。
（苏楠 审校）
Eur Respir J. 2009 Oct;34(4):803-811
Risk of mortality associated with formoterol: a systematic review and meta-analysis.
Wijesinghe M, Weatherall M, Perrin K, Harwood M, Beasley R.
There is concern long-acting beta-agonist (LABA) drugs may increase the risk of asthma mortality. We undertook a systematic review which included the AstraZeneca Formoterol Clinical Trial Safety Database and Novartis Food and Drug Administration Formoterol Briefing Document. Randomised controlled clinical trials of duration > or = 4 weeks that compared formoterol with a non-LABA comparator treatment in asthma were included in a meta-analysis of the risk of all-cause mortality and asthma death. Simple contingency tables, Peto’s one-step method and a Bayesian analysis were used. There were 42 deaths (nine from asthma) recorded in 62 studies with 49,327 subjects. The simple contingency table odds ratio for risk of all-cause mortality with formoterol was 1.1 (95% CI 0.6-2.2) and for asthma death was 2.7 (95% CI 0.5-26.7). Analyses by the other methods using both "as randomised" and "as exposed" classifications of treatment gave similar risk estimates with wide confidence and credible intervals. We conclude that there was insufficient power to determine whether formoterol increases the risk of mortality. However, the point estimates of a 2.0- to 3.2-fold increased risk of asthma death are not reassuring and add weight to evidence that LABA use in certain circumstances may increase the risk of asthma mortality.
Eur Respir J. 2009 Oct;34(4):803-11
结果采用简单列联表、Peto’s 一步法和Bayesian 分析。 在62项研究共包括49,327例受试人群中，发生42例死亡病例（9例死于哮喘）。简单列联表显示，采用福莫特罗治疗患者的全因死亡风险OR为1.1 (95% CI 0.6-2.2)，而哮喘死亡风险的OR为2.7 (95% CI 0.5-26.7)。对治疗采用“随机”和“暴露”分类后，运用其它方法进行分析也具有类似的风险估计值，只是可信区间较大。
我们认为，目前福莫特罗增加死亡风险的证据不足。然而哮喘死亡风险的点估计值增加2～3.2倍不能被认为是某些情况下LABA使用能增加哮喘死亡风险的证据。
（苏楠 审校）
Eur Respir J. 2009 Oct;34(4):803-811
Risk of mortality associated with formoterol: a systematic review and meta-analysis.
Wijesinghe M, Weatherall M, Perrin K, Harwood M, Beasley R.
There is concern long-acting beta-agonist (LABA) drugs may increase the risk of asthma mortality. We undertook a systematic review which included the AstraZeneca Formoterol Clinical Trial Safety Database and Novartis Food and Drug Administration Formoterol Briefing Document. Randomised controlled clinical trials of duration > or = 4 weeks that compared formoterol with a non-LABA comparator treatment in asthma were included in a meta-analysis of the risk of all-cause mortality and asthma death. Simple contingency tables, Peto’s one-step method and a Bayesian analysis were used. There were 42 deaths (nine from asthma) recorded in 62 studies with 49,327 subjects. The simple contingency table odds ratio for risk of all-cause mortality with formoterol was 1.1 (95% CI 0.6-2.2) and for asthma death was 2.7 (95% CI 0.5-26.7). Analyses by the other methods using both "as randomised" and "as exposed" classifications of treatment gave similar risk estimates with wide confidence and credible intervals. We conclude that there was insufficient power to determine whether formoterol increases the risk of mortality. However, the point estimates of a 2.0- to 3.2-fold increased risk of asthma death are not reassuring and add weight to evidence that LABA use in certain circumstances may increase the risk of asthma mortality.
Eur Respir J. 2009 Oct;34(4):803-11
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抗氧化维生素与哮喘预后评估之间的关系:文献复习与meta-分析
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非特应性哮喘及反流患儿支气管高反应性：抗反流治疗的作用
