在患有症状心力衰竭和贫血的患者中对达比波丁阿尔法进行随机双盲试验
Jalal K Ghali1, Inder S Anand, William T Abraham
1Wayne State University, Detroit, Mich, USA. jghali@med.wayne.edu
Circulation
|January 16, 2008
概括
治疗心力衰竭 (HF) 患者的贫血,使用阿尔法达伯波丁,并没有显著改善运动或生活质量. 然而,这种治疗耐受性很好,并显示出减少死亡率和住院病例的趋势.
科学领域:
- 心脏病学 心脏病学
- 血液学 血液学 血液学
- 临床试验 临床试验
背景情况:
- 贫血是心力衰竭 (HF) 患者不良结果的已知独立风险因素.
- 心力衰竭试验中的贫血研究 (STAMINA-HeFT) 是一项大型,多中心,随机,双盲,安慰剂控制的试验,旨在评估高心力衰竭患者的贫血治疗.
研究的目的:
- 评估阿尔法达伯波丁在治疗症状心力衰竭患者贫血方面的疗效.
- 确定贫血治疗对HF患者运动能力,功能状态和生活质量的影响.
主要方法:
- 319名患有症状性高血压和贫血 (血红蛋白9.0-12.5 g/dL) 的患者随机分配给接受阿尔法或安慰剂1年.
- 主要终点是27周跑步机炼时间的变化.
- 二级终点包括纽约心脏协会课程的变化,生活质量,以及所有原因死亡率或HF住院治疗的复合.
主要成果:
- 与安慰剂相比,达尔贝丁阿尔法有效增加了血红蛋白水平 (P<0.001).
- 运动持续时间,纽约心脏协会课程或生活质量没有显著改善.
- 报告指出,所有原因死亡或HF住院的风险降低的趋势 (HR 0.68;P=0.10).
结论:
- 在有症状的HF和贫血的患者中,使用阿尔法达伯波丁治疗没有产生显著的临床益处.
- 达尔贝丁阿尔法耐受性良好,并有效提高了血红蛋白水平.
- 降低发病率和死亡率的潜在趋势需要进一步调查.
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