作为主要血管加压药和脓毒性休克试验死亡率结局的替代指标，存活天数和无残疾天数。
Days alive and free as an alternative to a mortality outcome in pivotal vasopressor and septic shock trials.
机构信息
Centre for Heart Lung Innovation (HLI), St. Paul's Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada; Division of Critical Care Medicine, St. Paul's Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada.
Centre for Health Evaluation and Outcome Science (CHEOS), St. Paul's Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada.
出版信息
J Crit Care. 2018 Oct;47:333-337. doi: 10.1016/j.jcrc.2018.05.003. Epub 2018 May 12.
PURPOSE
RCTs in septic shock negative for mortality may show organ dysfunction benefits. We hypothesized that RCTs in septic shock show significant differences between treatment groups in organ support despite no mortality differences.
METHODS
RCTs of epinephrine vs. norepinephrine plus dobutamine, norepinephrine vs. dopamine and vasopressin vs. norepinephrine reported days alive and free ("DAF") of vasopressors, ventilation and RRT, by subtracting days with support from the lesser of 28 or days to death. We also assigned zero DAF to non-survivors ("DAF and Mortality") and calculated the composite "DAF vasopressors, ventilation and RRT".
RESULTS
Using "DAF", norepinephrine was better than dopamine for vasopressors. In contrast, using "DAF and Mortality", norepinephrine was better than dopamine for vasopressors, ventilation and RRT; norepinephrine + dobutamine was better than epinephrine for ventilation. Using the novel composite "DAF vasopressors, ventilation and RRT", norepinephrine + dobutamine was better than epinephrine (p = 0.033), norepinephrine better than dopamine (p = 0.03), and vasopressin better than norepinephrine in less severe shock (p = 0.03).
CONCLUSIONS
Differences between treatment groups in organ dysfunction in RCTs in septic shock occur despite lack of mortality differences depending on calculation method. If standardized and validated further, DAF could become the primary endpoint of RCTs in septic shock.
目的
在脓毒性休克中，阴性的死亡率随机对照试验（RCT）可能显示出器官功能障碍的益处。我们假设，尽管死亡率没有差异，但在脓毒性休克的 RCT 中，治疗组之间在器官支持方面可能存在显著差异。
方法
我们对肾上腺素与去甲肾上腺素加多巴酚丁胺、去甲肾上腺素与多巴胺以及血管加压素与去甲肾上腺素的 RCT 进行了研究，报告了血管加压素支持天数（"DAF"）和通气天数以及肾脏替代治疗（RRT）天数，通过从较少的 28 天或死亡天数中减去支持天数来计算。我们还将零 DAF 分配给非幸存者（"DAF 和死亡率"），并计算了复合的"DAF 血管加压素、通气和 RRT"。
结果
使用"DAF"，去甲肾上腺素在血管加压素方面优于多巴胺。相比之下，使用"DAF 和死亡率"，去甲肾上腺素在血管加压素、通气和 RRT 方面优于多巴胺；去甲肾上腺素+多巴酚丁胺在通气方面优于肾上腺素。使用新的复合"DAF 血管加压素、通气和 RRT"，去甲肾上腺素+多巴酚丁胺优于肾上腺素（p=0.033），去甲肾上腺素优于多巴胺（p=0.03），在病情较轻的休克中，血管加压素优于去甲肾上腺素（p=0.03）。
结论
根据计算方法，在脓毒性休克的 RCT 中，尽管死亡率没有差异，但治疗组在器官功能障碍方面仍存在差异。如果进一步标准化和验证，DAF 可能成为脓毒性休克 RCT 的主要终点。
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