Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS)
Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS)
复制标题
北斯堪的纳维亚依那普利合作生存研究（共识）
DOI：
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发表时间：
2007
期刊：
影响因子：
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通讯作者：
S. Snapinn
中科院分区：
文献类型：
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作者：
S. Snapinn
北斯堪的纳维亚依那普利生存研究（CONSENSUS）是一项具有里程碑意义的试验，证明了血管紧张素转换酶抑制剂依那普利在严重心力衰竭患者中的死亡率大幅降低。尽管该研究设计招募400名患者，但由于伦理审查委员会的建议，CONSENSUS仅终止了253名患者。总死亡率为68/126例安慰剂患者（54%）和50/127例依那普利患者（39%）; P = 0.003。其他分析表明，依那普利对死亡率的影响与激素激活有关，特别是与肾素-血管紧张素系统的激活有关。在试验终止后，对存活的CONSENSUS患者进行了额外的10年随访，当时有5名患者仍然存活，均来自依那普利组。
保留字：
提前终止;
伦理审查委员会;
心力衰竭;
长期跟踪;
神经激素
The Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS) was a landmark trial that demonstrated a large and highly significant reduction in mortality with the angiotensin-converting enzyme inhibitor, enalapril, in patients with severe heart failure. Although the study was designed to enroll 400 patients, CONSENSUS terminated with only 253 patients due to a recommendation from the ethics review committee. The overall mortality rates were 68 of 126 placebo patients (54%) and 50 of 127 enalapril patients (39%); P = 0.003. Additional analyses suggested that the effect of enalapril on mortality is related to hormonal activation, particularly to activation of the renin-angiotensin system. Surviving CONSENSUS patients were followed for an additional 10 years after termination of the trial, at which time five patients remained alive, all from the enalapril group.
Keywords:
early termination;
ethical review committee;
heart failure;
long-term follow-up;
neurohormones