Kudenchuk P J, Cobb L A, Copass M K, Cummins R O, Doherty A M, Fahrenbruch C E, Hallstrom A P, Murray W A, Olsufka M, Walsh T
Department of Medicine, University of Washington, Seattle 98195-6422, USA.
N Engl J Med. 1999 Sep 16;341(12):871-8. doi: 10.1056/NEJM199909163411203.
Whether antiarrhythmic drugs improve the rate of successful resuscitation after out-of-hospital cardiac arrest has not been determined in randomized clinical trials.
We conducted a randomized, double-blind, placebo-controlled study of intravenous amiodarone in patients with out-of-hospital cardiac arrest. Patients who had cardiac arrest with ventricular fibrillation (or pulseless ventricular tachycardia) and who had not been resuscitated after receiving three or more precordial shocks were randomly assigned to receive 300 mg of intravenous amiodarone (246 patients) or placebo (258 patients).
The treatment groups had similar clinical profiles. There was no significant difference between the amiodarone and placebo groups in the duration of the resuscitation attempt (42+/-16.4 and 43+/-16.3 minutes, respectively), the number of shocks delivered (4+/-3 and 6+/-5), or the proportion of patients who required additional antiarrhythmic drugs after the administration of the study drug (66 percent and 73 percent). More patients in the amiodarone group than in the placebo group had hypotension (59 percent vs. 48 percent, P=0.04) or bradycardia (41 percent vs. 25 percent, P=0.004) after receiving the study drug. Recipients of amiodarone were more likely to survive to be admitted to the hospital (44 percent, vs. 34 percent of the placebo group; P=0.03). The benefit of amiodarone was consistent among all subgroups and at all times of drug administration. The adjusted odds ratio for survival to admission to the hospital in the amiodarone group as compared with the placebo group was 1.6 (95 percent confidence interval, 1.1 to 2.4; P=0.02). The trial did not have sufficient statistical power to detect differences in survival to hospital discharge, which differed only slightly between the two groups.
In patients with out-of-hospital cardiac arrest due to refractory ventricular arrhythmias, treatment with amiodarone resulted in a higher rate of survival to hospital admission. Whether this benefit extends to survival to discharge from the hospital merits further investigation.
在随机临床试验中，尚未确定抗心律失常药物是否能提高院外心脏骤停后的成功复苏率。
我们对院外心脏骤停患者进行了一项关于静脉注射胺碘酮的随机、双盲、安慰剂对照研究。心脏骤停伴心室颤动（或无脉性室性心动过速）且在接受三次或更多次心前区电击后仍未复苏的患者被随机分配接受300mg静脉注射胺碘酮（246例患者）或安慰剂（258例患者）。
治疗组具有相似的临床特征。胺碘酮组和安慰剂组在复苏尝试持续时间（分别为42±16.4分钟和43±16.3分钟）、电击次数（4±3次和6±5次）或在给予研究药物后需要额外抗心律失常药物的患者比例（66%和73%）方面没有显著差异。接受研究药物后，胺碘酮组出现低血压（59%对48%，P=0.04）或心动过缓（41%对25%，P=0.004）的患者比安慰剂组更多。接受胺碘酮治疗的患者更有可能存活至入院（44%，而安慰剂组为34%；P=0.03）。胺碘酮的益处在所有亚组和给药的所有时间都是一致的。与安慰剂组相比，胺碘酮组入院存活的调整后优势比为1.6（95%置信区间，1.1至2.4；P=0.02）。该试验没有足够的统计效力来检测出院存活率的差异，两组之间仅略有不同。
对于因难治性室性心律失常导致院外心脏骤停的患者，胺碘酮治疗可提高入院存活率。这种益处是否能延伸至出院存活率值得进一步研究。
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