噻托溴铵与沙美特罗预防COPD急性加重的对比研究
2011/09/09
背景与目的：COPD治疗指南中推荐吸入长效支气管舒张剂来缓解患者症状及降低中-极重度COPD患者急性加重的危险性，但指南中并未具体指明长效抗胆碱能药物与长效B2肾上腺素受体激动剂相比哪种效果更好。该研究旨在阐明这一问题。
方法：此次研究共有7376例患者参与（纳入的病例包括中-极重度COPD患者及近1年内有COPD急性加重病史的患者）。期限为1年，采用随机、双盲双模拟、平行试验，其中3707例患者入噻托溴铵组（18ug qd）,3669例患者入沙美特罗组（50ug bid）。主要比较观察这两种药物对上述患者中重度急性加重的影响。
结果：与沙美特罗相比，噻托溴铵延长了COPD患者第1次加重的时间（187天VS 145天），恶化风险减少了17%（风险比，0.83 95%CI 0.77～0.90 P<0.00I）。噻托溴铵还可延长第1次严重恶化时间（风险比，0.72 95%CI 0.61～0.85 P<0.001），减少1年内中到重度发作次数（0.64 VS 0.72；风险比，0.89 95%CI 0.83～0.96 P=0.002），减少1年内重度发作次数（0.09 VS 0.13；风险比，0.73 95%CI 0.66～0.82 P<0.001）。严重不良事件及不良事件导致治疗中断的发生率在两组中是相似的；噻托溴铵组死亡率1.7%，沙美特罗组死亡率2.1%。
结论：噻托溴铵预防中-极重度COPD患者病情急性加重的效果要优于沙美特罗。
（戴元荣 王瑞丽 温州医学院附属第二医院呼吸内科 325000 摘译)
（N Engl J Med 2011，364:1093-1103）
Tiotropium versus Salmeterol for the Prevention of Exacerbations of COPD
Claus Vogelmeier, M.D., Bettina Hederer, M.D., Thomas Glaab, M.D., Hendrik Schmidt, Ph.D., Maureen P.M.H. Rutten-van Mölken, Ph.D., Kai M. Beeh, M.D., Klaus F. Rabe, M.D., and Leonardo M. Fabbri, M.D. for the POET-COPD Investigators
N Engl J Med 2011; 364:1093-1103March 24, 2011
Background
Treatment guidelines recommend the use of inhaled long-acting bronchodilators to alleviate symptoms and reduce the risk of exacerbations in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD) but do not specify whether a long-acting anticholinergic drug or a β2-agonist is the preferred agent. We investigated whether the anticholinergic drug tiotropium is superior to the β2-agonist salmeterol in preventing exacerbations of COPD.
Methods
In a 1-year, randomized, double-blind, double-dummy, parallel-group trial, we compared the effect of treatment with 18 μg of tiotropium once daily with that of 50 μg of salmeterol twice daily on the incidence of moderate or severe exacerbations in patients with moderate-to-very-severe COPD and a history of exacerbations in the preceding year.
Results
A total of 7376 patients were randomly assigned to and treated with tiotropium (3707 patients) or salmeterol (3669 patients). Tiotropium, as compared with salmeterol, increased the time to the first exacerbation (187 days vs. 145 days), with a 17% reduction in risk (hazard ratio, 0.83; 95% confidence interval [CI], 0.77 to 0.90; P<0.001). Tiotropium also increased the time to the first severe exacerbation (hazard ratio, 0.72; 95% CI, 0.61 to 0.85; P<0.001), reduced the annual number of moderate or severe exacerbations (0.64 vs. 0.72; rate ratio, 0.89; 95% CI, 0.83 to 0.96; P=0.002), and reduced the annual number of severe exacerbations (0.09 vs. 0.13; rate ratio, 0.73; 95% CI, 0.66 to 0.82; P<0.001). Overall, the incidence of serious adverse events and of adverse events leading to the discontinuation of treatment was similar in the two study groups. There were 64 deaths (1.7%) in the tiotropium group and 78 (2.1%) in the salmeterol group.
Conclusions
These results show that, in patients with moderate-to-very-severe COPD, tiotropium is more effective than salmeterol in preventing exacerbations. (Funded by Boehringer Ingelheim and Pfizer; ClinicalTrials.gov number, NCT00563381.)
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