胺碘酮、利多卡因或安慰剂治疗院外心脏骤停。
Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest.
机构信息
From the Department of Medicine (P.J.K., T.R., G.N.) and Division of Cardiology (P.J.K.), University of Washington, the King County Emergency Medical Services, Public Health (P.J.K., T.R.), the Department of Biostatistics, University of Washington Clinical Trial Center (S.P.B., G.N., B.L.), and University of Washington-Harborview Center for Prehospital Emergency Care (G.N.), Seattle, and Clark County Emergency Medical Services, Vancouver (L.W.) - all in Washington; the Department of Emergency Medicine, Oregon Health and Science University, Portland (M.D.); Rescu, Li Ka Shing Knowledge Institute, St. Michael's Hospital (L.J.M., P.D.), and the Divisions of Emergency Medicine (L.J.M.) and Cardiology (P.D.), Department of Medicine, University of Toronto, Toronto, the Department of Emergency Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa (C.V., I.G.S.), and the Department of Emergency Medicine, Providence Health Care Research Institute, University of British Columbia Faculty of Medicine (J.C.), and Providence Health Care Research Institute and British Columbia Emergency Health Services (R.S.), Vancouver - all in Canada; University of Pittsburgh, Pittsburgh (C.W.C., A.M.B.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda (D.E., P.D.-N.), and Johns Hopkins University, Baltimore (M.L.W.) - both in Maryland; the Department of Emergency Medicine, Virginia Commonwealth University, Richmond (J.P.O.); the Departments of Emergency Medicine and Internal Medicine, University of Texas Southwestern Medical Center (A.H.I.), and Dallas Fire-Rescue Department (N.S.) - both in Dallas; the Departments of Emergency Medicine (T.P.A.) and Pediatrics (M.R.C.), Medical College of Wisconsin, Milwaukee; the Department of Emergency Medicine, University of California San Diego (J.V.D., G.M.V.), and San Diego Fire-Rescue Department (J.V.D.) - both in San Diego; and University of Alabama at Birmingham, Birmingham (P.C.G., R.G.).
出版信息
N Engl J Med. 2016 May 5;374(18):1711-22. doi: 10.1056/NEJMoa1514204. Epub 2016 Apr 4.
BACKGROUND
Antiarrhythmic drugs are used commonly in out-of-hospital cardiac arrest for shock-refractory ventricular fibrillation or pulseless ventricular tachycardia, but without proven survival benefit.
METHODS
In this randomized, double-blind trial, we compared parenteral amiodarone, lidocaine, and saline placebo, along with standard care, in adults who had nontraumatic out-of-hospital cardiac arrest, shock-refractory ventricular fibrillation or pulseless ventricular tachycardia after at least one shock, and vascular access. Paramedics enrolled patients at 10 North American sites. The primary outcome was survival to hospital discharge; the secondary outcome was favorable neurologic function at discharge. The per-protocol (primary analysis) population included all randomly assigned participants who met eligibility criteria and received any dose of a trial drug and whose initial cardiac-arrest rhythm of ventricular fibrillation or pulseless ventricular tachycardia was refractory to shock.
RESULTS
In the per-protocol population, 3026 patients were randomly assigned to amiodarone (974), lidocaine (993), or placebo (1059); of those, 24.4%, 23.7%, and 21.0%, respectively, survived to hospital discharge. The difference in survival rate for amiodarone versus placebo was 3.2 percentage points (95% confidence interval [CI], -0.4 to 7.0; P=0.08); for lidocaine versus placebo, 2.6 percentage points (95% CI, -1.0 to 6.3; P=0.16); and for amiodarone versus lidocaine, 0.7 percentage points (95% CI, -3.2 to 4.7; P=0.70). Neurologic outcome at discharge was similar in the three groups. There was heterogeneity of treatment effect with respect to whether the arrest was witnessed (P=0.05); active drugs were associated with a survival rate that was significantly higher than the rate with placebo among patients with bystander-witnessed arrest but not among those with unwitnessed arrest. More amiodarone recipients required temporary cardiac pacing than did recipients of lidocaine or placebo.
CONCLUSIONS
Overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo among patients with out-of-hospital cardiac arrest due to initial shock-refractory ventricular fibrillation or pulseless ventricular tachycardia. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT01401647.).
背景
在院外心脏骤停中，抗心律失常药物通常用于治疗电击无效的室颤或无脉性室速，但并无生存获益的确切证据。
方法
在这项随机、双盲试验中，我们比较了静脉注射胺碘酮、利多卡因和生理盐水安慰剂，以及标准治疗，用于非创伤性院外心脏骤停、电击无效的室颤或无脉性室速且已建立血管通路的成人患者。急救医疗技术员在北美 10 个地点招募患者。主要结局为出院时的生存情况；次要结局为出院时的神经功能良好。意向治疗人群（主要分析人群）包括所有符合入选标准并接受任何剂量试验药物且初始心脏骤停节律为室颤或无脉性室速且对电击无效的随机分配参与者。
结果
在意向治疗人群中，3026 例患者被随机分配至胺碘酮组（974 例）、利多卡因组（993 例）或安慰剂组（1059 例）；其中，分别有 24.4%、23.7%和 21.0%的患者存活至出院。胺碘酮组与安慰剂组的生存率差异为 3.2 个百分点（95%置信区间，-0.4 至 7.0；P=0.08）；利多卡因组与安慰剂组的差异为 2.6 个百分点（95%置信区间，-1.0 至 6.3；P=0.16）；胺碘酮组与利多卡因组的差异为 0.7 个百分点（95%置信区间，-3.2 至 4.7；P=0.70）。三组出院时的神经功能结局相似。对于是否目击到心脏骤停，治疗效果存在异质性（P=0.05）；在有旁观者目击的心脏骤停患者中，与安慰剂相比，活性药物的生存率显著更高，但在无旁观者目击的患者中，两者无显著差异。胺碘酮组比利多卡因组和安慰剂组更需要临时心脏起搏。
结论
在初始电击无效的室颤或无脉性室速导致的院外心脏骤停患者中，胺碘酮和利多卡因均未显著提高生存率或改善神经功能结局，与安慰剂相比无显著差异。（由美国国立心肺血液研究所和其他机构资助；ClinicalTrials.gov 注册号：NCT01401647。）
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