Norepinephrine plus dobutamine versus epinephrine alone for management of septic shock:: a randomised trial
Norepinephrine plus dobutamine versus epinephrine alone for management of septic shock:: a randomised trial
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DOI：
10.1016/s0140-6736(07)61344-0
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发表时间：
2007-08-25
期刊：
影响因子：
168.9
通讯作者：
Bellissant, Eric
中科院分区：
文献类型：
--
作者：
Annane, Djillali;Vignon, Philippe;Bellissant, Eric
背景：国际脓毒性休克治疗指南推荐多巴胺或去甲肾上腺素优于肾上腺素。然而，尚未进行大规模的比较试验。我们的目的是比较去甲肾上腺素加多巴酚丁胺（无论何时需要）与单用肾上腺素治疗感染性休克的疗效和安全性。方法：这项前瞻性、多中心、随机、双盲研究在330例感染性休克患者中进行，这些患者入住法国19个参与研究的重症监护病房之一。参与者被分配接受肾上腺素（n=161）或去甲肾上腺素加多巴酚丁胺（n=169），滴定以维持平均血压在70 mm Hg或更高。主要结局为28天全因死亡率。该试验在ClinicalTrials.gov注册，编号NCT 00148278。结果：没有患者失访; 1例患者在3天后撤回知情同意书。在第28天，肾上腺素组有64例（40%）死亡，去甲肾上腺素加多巴酚丁胺组有58例（34%）死亡（p=0中心点31;相对风险0中心点86，95%CI 0中心点65-1中心点14）。两组患者在重症监护室出院时的死亡率没有显著差异（出院时75例[47%]死亡vs 75例[44%]死亡，p=0，中心点69）（84 [52%] vs 82 [49%]，p= 0，中心点51），到第90天（84 [52%] vs 85 [50%]，p= 0中心点73），血流动力学成功时间（对数秩p= 0，中心点67）、至血管加压药停用时间（对数秩p= 0，中心点09）和SOFA评分的时间过程。严重不良事件的发生率也相似。没有证据表明单用肾上腺素和去甲肾上腺素加多巴酚丁胺治疗感染性休克的疗效和安全性有差异。
Background International guidelines for management of septic shock recommend that dopamine or norepinephrine are preferable to epinephrine. However, no large comparative trial has yet been done. We aimed to compare the efficacy and safety of norepinephrine plus dobutamine (whenever needed) with those of epinephrine alone in septic shock. Methods This prospective, multicentre, randomised, double-blind study was done in 330 patients with septic shock admitted to one of 19 participating intensive care units in France. Participants were assigned to receive epinephrine (n=161) or norepinephrine plus dobutamine (n=169), which were titrated to maintain mean blood pressure at 70 mm, Hg or more. The primary outcome was 28-day all-cause mortality. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00148278. Findings There were no patients lost to follow-up; one patient withdrew consent after 3 days. At day 28, there were 64 (40%) deaths in the epinephrine group and 58 (34%) deaths in the norepinephrine plus dobutamine group (p=0 center dot 31; relative risk 0 center dot 86, 95% Cl 0 center dot 65-1 center dot 14). There was no significant difference between the two groups in mortality rates at discharge from intensive care (75 [47%] deaths vs 75 [44%] deaths, p=0 center dot 69), at hospital discharge (84 [52%] vs 82 [49%], p= 0 center dot 51), and by day 90 (84 [52%] vs 85 [50%], p= 0 center dot 73), time to haemodynamic success (log-rank p= 0 center dot 67), time to vasopressor withdrawal (log-rank p= 0 center dot 09), and time course of SOFA score. Rates of serious adverse events were also similar. Interpretation There is no evidence for a difference in efficacy and safety between epinephrine alone and norepinephrine plus dobutamine for the management of septic shock.