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一项肾上腺素在院外心脏骤停中的随机试验。

A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest.

机构信息

From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.

出版信息

N Engl J Med. 2018 Aug 23;379(8):711-721. doi: 10.1056/NEJMoa1806842. Epub 2018 Jul 18.

Abstract

BACKGROUND

Concern about the use of epinephrine as a treatment for out-of-hospital cardiac arrest led the International Liaison Committee on Resuscitation to call for a placebo-controlled trial to determine whether the use of epinephrine is safe and effective in such patients.

METHODS

In a randomized, double-blind trial involving 8014 patients with out-of-hospital cardiac arrest in the United Kingdom, paramedics at five National Health Service ambulance services administered either parenteral epinephrine (4015 patients) or saline placebo (3999 patients), along with standard care. The primary outcome was the rate of survival at 30 days. Secondary outcomes included the rate of survival until hospital discharge with a favorable neurologic outcome, as indicated by a score of 3 or less on the modified Rankin scale (which ranges from 0 [no symptoms] to 6 [death]).

RESULTS

At 30 days, 130 patients (3.2%) in the epinephrine group and 94 (2.4%) in the placebo group were alive (unadjusted odds ratio for survival, 1.39; 95% confidence interval [CI], 1.06 to 1.82; P=0.02). There was no evidence of a significant difference in the proportion of patients who survived until hospital discharge with a favorable neurologic outcome (87 of 4007 patients [2.2%] vs. 74 of 3994 patients [1.9%]; unadjusted odds ratio, 1.18; 95% CI, 0.86 to 1.61). At the time of hospital discharge, severe neurologic impairment (a score of 4 or 5 on the modified Rankin scale) had occurred in more of the survivors in the epinephrine group than in the placebo group (39 of 126 patients [31.0%] vs. 16 of 90 patients [17.8%]).

CONCLUSIONS

In adults with out-of-hospital cardiac arrest, the use of epinephrine resulted in a significantly higher rate of 30-day survival than the use of placebo, but there was no significant between-group difference in the rate of a favorable neurologic outcome because more survivors had severe neurologic impairment in the epinephrine group. (Funded by the U.K. National Institute for Health Research and others; Current Controlled Trials number, ISRCTN73485024 .).

摘要

背景

对肾上腺素在院外心脏骤停治疗中的应用的担忧,促使国际复苏联合会呼吁开展一项安慰剂对照试验,以确定肾上腺素在这类患者中的应用是否安全有效。

方法

在英国的一项涉及 8014 例院外心脏骤停患者的随机、双盲试验中,5 家国家卫生服务救护车服务机构的护理人员给患者使用肾上腺素(4015 例)或生理盐水安慰剂(3999 例),并联合标准治疗。主要结局为 30 天的生存率。次要结局包括具有良好神经功能结局(改良 Rankin 量表评分为 3 分或以下,评分范围为 0 分[无症状]至 6 分[死亡])的患者出院时的生存率。

结果

30 天时,肾上腺素组 130 例(3.2%)患者和安慰剂组 94 例(2.4%)患者存活(校正后的生存优势比,1.39;95%置信区间[CI],1.06 至 1.82;P=0.02)。没有证据表明具有良好神经功能结局的出院患者比例存在显著差异(4007 例患者中存活 87 例[2.2%] vs. 3994 例患者中存活 74 例[1.9%];校正后的优势比,1.18;95%CI,0.86 至 1.61)。出院时,肾上腺素组存活者中严重神经功能障碍(改良 Rankin 量表评分为 4 或 5 分)的发生率高于安慰剂组(126 例患者中 39 例[31.0%] vs. 90 例患者中 16 例[17.8%])。

结论

在院外心脏骤停的成人中,与使用安慰剂相比,使用肾上腺素可显著提高 30 天生存率,但两组间具有良好神经功能结局的患者比例无显著差异,因为肾上腺素组更多的存活者有严重的神经功能障碍。(由英国国家卫生研究院和其他机构资助;当前对照试验编号,ISRCTN73485024。)

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