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杜皮卢马布治疗COPD的2型炎症,以乙氨基酸细胞计数为指标
Surya P Bhatt1, Klaus F Rabe1, Nicola A Hanania1
1From the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (S.P.B.); LungenClinic Grosshansdorf and Christian Albrechts University of Kiel, Airway Research Center North, German Center for Lung Research, Grosshansdorf (K.F.R.), and the Department of Medicine, Pulmonary, and Critical Care Medicine, University of Marburg, German Center for Lung Research, Marburg (C.F.V.) - all in Germany; the Department of Medicine, Section on Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston (N.A.H.); OK Clinical Research, Edmond, OK (J.C.); King's Centre for Lung Health, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, London (M.B.), and Manchester University NHS Foundation Trust, University of Manchester, Manchester (D.S.) - both in the United Kingdom; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine, University of California, San Francisco, San Francisco (S.A.C.); the University of Ferrara, Ferrara, Italy (A.P.); Sanofi, Bridgewater, NJ (E.L., H.W.S., X.L., D.B.); Sanofi, Chilly-Mazarin, France (L.P.M.); Sanofi, Cambridge, MA (N.P., L.B.R., R.M.A.); and Regeneron Pharmaceuticals, Tarrytown, NY (G.D.Y., E.R.M., B.A., J.M., A.B.).
在患有慢性阻塞性肺病 (COPD) 和2型炎症的患者中,dupilumab显著降低了恶化. 这种治疗还改善了肺功能,生活质量和呼吸系统症状.
科学领域:
- 肺部病理学 肺部病理学
- 免疫学 免疫学 免疫学
- 临床试验 临床试验
背景情况:
- 慢性肺炎的2型炎症,通过血中异氨基细胞的升高表明,与恶化风险的增加有关.
- 杜皮卢马布向介素-4和介素-13,这是2型炎症的关键媒介.
研究的目的:
- 评估dupilumab在降低COPD和2型炎症患者恶化的疗效.
- 评估dupilumab对肺功能,生活质量和呼吸系统症状的影响.
主要方法:
- 一个第三阶段,双盲,随机试验,涉及939名COPD患者和血中异氨基细胞计数≥300/μL.
- 患者每两周接受一次皮下注射杜皮卢马布 (300毫克) 或安慰剂.
- 主要终点:中度或重度COPD恶化的年率. 二级终点包括FEV1,SGRQ和E-RS-COPD得分的变化.
主要成果:
- 与安慰剂相比,dupilumab显著降低了30%的年化恶化率 (比率比率为0.70;P<0.001).
- 随着dupilumab的使用,预支气管扩展剂FEV1,圣乔治呼吸问卷 (SGRQ) 评分和评估COPD呼吸道症状 (E-RS-COPD) 评分的改善得到观察,并持续了52周.
- 在dupilumab和安慰剂组之间,不良事件,严重不良事件和死亡事件是平衡的.
结论:
- 杜皮卢马布有效地减少了COPD患者的恶化,这些患者患有2型炎症.
- 治疗表明肺功能,生活质量和呼吸系统症状严重程度有显著改善.
- 杜皮卢马布为COPD患者的一个特定亚组提供了潜在的治疗选择.
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