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噻托溴铵和沙美特罗用于预防COPD加重的比较研究
Tiotropium versus Salmeterol for the Prevention of Exacerbations of COPD


Claus Vogelmeier ... 呼吸系统疾病 • 2011.03.24
相关阅读
• 噻托溴铵治疗轻度COPD • COPD加重患者何时适用无创通气 • 噻托溴铵治疗早期慢性阻塞性肺疾病 • 茚达特罗-格隆溴铵与沙美特罗-氟替卡松治疗COPD的比较研究 • 噻托溴铵能倍乐吸入器和在COPD中的死亡危险 • COPD患者第一秒用力呼气量随时间的变化

摘要


背景

对于中度至极重度慢性阻塞性肺疾病(COPD)患者,治疗指南推荐使用吸入性长效支气管扩张剂缓解其症状,并降低疾病加重的危险,但是并未明确指出应优选长效抗胆碱药还是β2受体激动药。我们研究了在预防COPD加重方面,抗胆碱药噻托溴铵是否优于β2受体激动药沙美特罗。

 

方法

在本项为期1年的随机、双盲、双模拟的平行组试验中,我们在有中度至极重度COPD且前一年有加重病史的患者中,比较了每天一次18 µg噻托溴铵与每天两次50 µg沙美特罗的治疗对患者COPD中度或重度加重发生率的疗效。

 

结果

共计7,376例患者被随机分配至噻托溴铵治疗组(3,707例)或沙美特罗治疗组(3,669例)。噻托溴铵与沙美特罗相比延长了至首次加重的时间(187天对145天),降低了17%的风险(危险比,0.83;95%置信区间[CI],0.77~0.90;P<0.001)。噻托溴铵还延长了至首次重度加重的时间(危险比,0.72;95% CI,0.61~0.85;P<0.001),降低了中度或重度加重的年发生次数(0.64对0.72;率比,0.89;95% CI,0.83~0.96;P=0.002),同时降低了重度加重的年发生次数(0.09对0.13;率比,0.73;95% CI,0.66~0.82;P<0.001)。两研究组的总体严重不良事件发生率以及导致治疗终止的不良事件发生率相似。噻托溴铵组有64例(1.7%)、沙美特罗组有78例(2.1%)患者死亡。

 

结论

这些结果表明,对于中度到极重度COPD患者,噻托溴铵在预防加重方面比沙美特罗更有效[该研究由勃林格殷格翰公司和辉瑞公司资助;在ClinicalTrails.gov注册号为NCT00563381]。





作者信息

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*
From the Hospital of the Universities of Giessen and Marburg, Marburg (C.V.); Boehringer Ingelheim, Ingelheim (B.H., T.G., H.S.); and insaf Respiratory Research Institute, Wiesbaden (K.M.B.) — all in Germany; the Institute for Medical Technology Assessment (IMTA), Erasmus University, Rotterdam (M.P.M.H.R.-M.); and Leiden University Medical Center, Leiden (K.F.R.) — both in the Netherlands; and the University of Modena and Reggio Emilia, Modena, Italy (L.M.F.). Address reprint requests to Dr. Fabbri at the Section of Respiratory Diseases, Department of Oncology, Hematology, and Pulmonary Diseases, University of Modena and Reggio Emilia, Policlinico di Modena, Largo del Pozzo 71, I-41124 Modena, Italy, or at leonardo.fabbri@unimore.it. *The investigators in the Prevention of Exacerbations with Tiotropium in COPD (POET-COPD) trial are listed in the Supplementary Appendix, available at NEJM.org.

 

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