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噻托溴铵能倍乐吸入器和在COPD中的死亡危险
Tiotropium Respimat Inhaler and the Risk of Death in COPD


Robert A. Wise ... 呼吸系统疾病 • 2013.10.17
相关阅读
• 噻托溴铵治疗轻度COPD • 噻托溴铵治疗早期慢性阻塞性肺疾病 • 噻托溴铵治疗标准联合疗法控制不佳的哮喘 • COPD患者第一秒用力呼气量随时间的变化 • 噻托溴铵和沙美特罗用于预防COPD加重的比较研究

摘要


背景

在有慢性阻塞性肺疾病(COPD)患者参与的安慰剂对照试验中,使用能倍乐(Respimat)吸入器以5 μg的剂量递送噻托溴铵显示出与使用吸乐(HandiHaler)吸入装置递送18 μg噻托溴铵相似的疗效。与安慰剂相比,尽管噻托溴铵吸乐与死亡率降低有关,但使用噻托溴铵能倍乐比使用安慰剂报告的死亡更多。

 

方法 

在这项包括17,135例COPD患者的随机、双盲、平行组试验中,我们将每日给药一次(剂量2.5 μg或5 μg)的噻托溴铵能倍乐与每日一次(剂量18 μg)的噻托溴铵吸乐相比较,对其进行安全性和疗效评价。主要终点是死亡危险(非劣效性研究,能倍乐5 μg或2.5 μg剂量对吸乐)和首次COPD加重危险(优效性研究,能倍乐5 μg剂量对吸乐)。我们还评估了包括稳定性心脏疾病患者的安全性在内的心血管安全性。

 

结果 

在平均2.3年的随访期间,能倍乐在死亡危险方面不劣于吸乐(能倍乐5 μg剂量对吸乐:风险比,0.96;95%置信区间[CI],0.84~1.09;能倍乐2.5 μg剂量对吸乐:风险比,1.00;95% CI,0.87~1.14),且在首次加重危险方面不优于吸乐(能倍乐5 μg剂量对吸乐:风险比,0.98;95% CI,0.93~1.03)。三组中的死亡原因及主要心血管不良事件发生率相似。

 

结论 

在COPD患者中,剂量5 μg或2.5 μg的噻托溴铵能倍乐与剂量18 μg的噻托溴铵吸乐在安全性和对病情加重的疗效相似(由勃林格殷格翰公司资助;TIOSPIR在ClinicalTrials.gov注册号为NCT01126437)。





作者信息

Robert A. Wise, M.D., Antonio Anzueto, M.D., Daniel Cotton, M.S., Ronald Dahl, M.D., Theresa Devins, Dr.Ph., Bernd Disse, M.D., Daniel Dusser, M.D., Elizabeth Joseph, M.P.H., Sabine Kattenbeck, Ph.D., Michael Koenen-Bergmann, M.D., Gordon Pledger, Ph.D., and Peter Calverley, D.Sc., for the TIOSPIR Investigators*
From Johns Hopkins University School of Medicine, Baltimore (R.A.W.); University of Texas Health Science Center and South Texas Veterans Health Care System, San Antonio (A.A.), and private practice, Hamilton (G.P.) — both in Texas; Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (D.C., T.D., E.J.); Odense University Hospital, Odense, Denmark (R.D.); Boehringer Ingelheim, Ingelheim, Germany (B.D., S.K., M.K.-B.); Service de Pneumologie Hôpital Cochin, Assistance Publique–Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris (D.D.); and Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom (P.C.).Address reprint requests to Dr. Wise at Johns Hopkins University School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, or at rwise@jhmi.edu. *Investigators in the Tiotropium Safety and Performance in Respimat (TIOSPIR) study are listed in theSupplementary Appendix, available at NEJM.org.

 

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