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背景对长效β-促效剂(long-acting βagonist,LABA)可增加哮喘死亡风险的担忧。方法对GlaxoSmithKline数据库随机对照试验中用了沙美特罗和非LABA治疗的哮喘死亡病例进行荟萃分析。用Peto一步法对总体(所有研究)风险和根据吸入皮质类固醇使用衍生数据进行调查研究。结果含有106575受试者215个研究有35例死于哮喘。2项研究(SMART和SNS)有30/35(86%)死亡病例,总发现在很大程度上反映出这些研究特性。沙美特罗哮喘死亡风险优势比为2.7[95%CI(1.4,5.3)]。54个安慰剂对照研究未用ICS哮喘病人死亡风险为7.3[95%CI(1.8,29.4)]。127个研究病人用了ICS,哮喘死亡风险为2.1[95%CI(0.6,7.9)]。63个随机对照研究病人用了沙美特罗/丙酸氟替卡松吸入剂或ICS,22600病人中无哮喘死亡病例。结论哮喘沙美特罗单一疗法可增加哮喘死亡风险,但是与ICS共用可减少这种风险。尚无证据表明沙美特罗/丙酸氟替卡松吸入剂ICS结合治疗会增加哮喘死亡风险,虽然现有研究还缺少有力数据能对此做出解释。
BACKGROUND Long-acting betaagonist (LABA) increases the risk of asthma death. Methods Meta-analyzes were performed on the deaths from asthma using the salmeterol and non-LABA randomized controlled trials of the GlaxoSmithKline database. Investigate the overall (all study) risk and derived data based on inhaled corticosteroid use using Peto’s one-step approach. RESULTS: Of the 215 studies containing 105,575 subjects, 35 died of asthma. Two studies (SMART and SNS) reported 30 of 35 (86%) deaths and the overall findings to a large extent reflect the characteristics of these studies. The odds ratio for the risk of death from salmeterol for stroke was 2.7 [95% CI (1.4,5.3)]. The risk of death from asthma in 54 placebo-controlled studies without ICS was 7.3 [95% CI (1.8, 29.4)]. In 127 study patients with ICS, the risk of death from asthma was 2.1 [95% CI (0.6, 7.9)]. Sixty-three randomized controlled study patients were treated with salmeterol / fluticasone propionate inhaler or ICS and no deaths from asthma were found in 22,600 patients. Conclusion Salmeterol monotherapy with asthma increased the risk of death from asthma, but sharing it with ICS reduced this risk. There is no evidence that salmeterol / fluticasone propionate inhalant ICS treatment increases the risk of death from asthma, although there is a paucity of strong data available to explain this.