米力农与多巴酚丁胺治疗心源性休克的比较。
Milrinone as Compared with Dobutamine in the Treatment of Cardiogenic Shock.
机构信息
From the CAPITAL Research Group, Division of Cardiology (R.M., P.D.S., R.G.J., J.A.M., T.S., F.D.R., D.T.H., O.A.-R., M.F., M.L., M.R.L.M., J.J.R., B.H.), the Cardiovascular Research Methods Centre (J.B., G.A.W.), and the Division of Cardiac Surgery (V.C.), University of Ottawa Heart Institute, and the Faculty of Medicine (R.M., P.D.S., R.G.J., J.H., D.T.H., W.W., O.A.-R., S.M.F., K.K., M.F., M.L., M.R.L.M., J.J.R., B.H.), the Division of Critical Care, Department of Medicine (R.M., J.H., S.M.F., K.K.), the School of Epidemiology and Public Health (P.D.S.), and the Department of Cellular and Molecular Medicine (R.G.J., T.S., B.H.), University of Ottawa, Ottawa, the Division of Cardiology, University of Toronto, Toronto (A.M.), and the Division of Cardiology, University of British Columbia, Vancouver (A.A.) - all in Canada; the Division of Critical Care, Tufts Medical Center, Boston (J.A.M.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (T.S.); and Hôpital Cardiologique du Haut Lévêque, Centre Hospitalier Universitaire Bordeaux (F.D.R.), and LIRYC (L'Institut de Rythmologie et Modélisation Cardiaque) (F.D.R.) - both in Bordeaux-Pessac, France.
出版信息
N Engl J Med. 2021 Aug 5;385(6):516-525. doi: 10.1056/NEJMoa2026845.
BACKGROUND
Cardiogenic shock is associated with substantial morbidity and mortality. Although inotropic support is a mainstay of medical therapy for cardiogenic shock, little evidence exists to guide the selection of inotropic agents in clinical practice.
METHODS
We randomly assigned patients with cardiogenic shock to receive milrinone or dobutamine in a double-blind fashion. The primary outcome was a composite of in-hospital death from any cause, resuscitated cardiac arrest, receipt of a cardiac transplant or mechanical circulatory support, nonfatal myocardial infarction, transient ischemic attack or stroke diagnosed by a neurologist, or initiation of renal replacement therapy. Secondary outcomes included the individual components of the primary composite outcome.
RESULTS
A total of 192 participants (96 in each group) were enrolled. The treatment groups did not differ significantly with respect to the primary outcome; a primary outcome event occurred in 47 participants (49%) in the milrinone group and in 52 participants (54%) in the dobutamine group (relative risk, 0.90; 95% confidence interval [CI], 0.69 to 1.19; P = 0.47). There were also no significant differences between the groups with respect to secondary outcomes, including in-hospital death (37% and 43% of the participants, respectively; relative risk, 0.85; 95% CI, 0.60 to 1.21), resuscitated cardiac arrest (7% and 9%; hazard ratio, 0.78; 95% CI, 0.29 to 2.07), receipt of mechanical circulatory support (12% and 15%; hazard ratio, 0.78; 95% CI, 0.36 to 1.71), or initiation of renal replacement therapy (22% and 17%; hazard ratio, 1.39; 95% CI, 0.73 to 2.67).
CONCLUSIONS
In patients with cardiogenic shock, no significant difference between milrinone and dobutamine was found with respect to the primary composite outcome or important secondary outcomes. (Funded by the Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario; ClinicalTrials.gov number, NCT03207165.).
背景
心源性休克与大量发病率和死亡率相关。虽然正性肌力支持是治疗心源性休克的主要方法，但在临床实践中，几乎没有证据可以指导正性肌力药物的选择。
方法
我们以双盲的方式将心源性休克患者随机分配接受米力农或多巴酚丁胺治疗。主要结局是院内任何原因导致的死亡、复苏性心脏骤停、接受心脏移植或机械循环支持、非致命性心肌梗死、经神经病学家诊断的短暂性脑缺血发作或中风、或开始肾脏替代治疗的复合结局。次要结局包括主要复合结局的各个组成部分。
结果
共有 192 名参与者（每组 96 名）入组。治疗组在主要结局方面无显著差异；米力农组有 47 名（49%）参与者和多巴酚丁胺组有 52 名（54%）参与者发生主要结局事件（相对风险，0.90；95%置信区间[CI]，0.69 至 1.19；P=0.47）。两组在次要结局方面也没有显著差异，包括院内死亡率（分别为 37%和 43%的参与者；相对风险，0.85；95%CI，0.60 至 1.21）、复苏性心脏骤停（7%和 9%；危险比，0.78；95%CI，0.29 至 2.07）、接受机械循环支持（12%和 15%；危险比，0.78；95%CI，0.36 至 1.71）或开始肾脏替代治疗（22%和 17%；危险比，1.39；95%CI，0.73 至 2.67）。
结论
在心源性休克患者中，米力农和多巴酚丁胺在主要复合结局或重要次要结局方面无显著差异。（由安大略省学术卫生保健中心替代供资计划创新基金资助；ClinicalTrials.gov 编号，NCT03207165。）
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