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肾上腺素对院外心脏骤停患者生存的影响:一项随机、双盲、安慰剂对照试验。

Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial.

机构信息

Discipline of Emergency Medicine (M516), University of Western Australia, Crawley, 6009 Western Australia, Australia.

出版信息

Resuscitation. 2011 Sep;82(9):1138-43. doi: 10.1016/j.resuscitation.2011.06.029. Epub 2011 Jul 2.

Abstract

BACKGROUND

There is little evidence from clinical trials that the use of adrenaline (epinephrine) in treating cardiac arrest improves survival, despite adrenaline being considered standard of care for many decades. The aim of our study was to determine the effect of adrenaline on patient survival to hospital discharge in out of hospital cardiac arrest.

METHODS

We conducted a double blind randomised placebo-controlled trial of adrenaline in out-of-hospital cardiac arrest. Identical study vials containing either adrenaline 1:1000 or placebo (sodium chloride 0.9%) were prepared. Patients were randomly allocated to receive 1 ml aliquots of the trial drug according to current advanced life support guidelines. Outcomes assessed included survival to hospital discharge (primary outcome), pre-hospital return of spontaneous circulation (ROSC) and neurological outcome (Cerebral Performance Category Score - CPC).

RESULTS

A total of 4103 cardiac arrests were screened during the study period of which 601 underwent randomisation. Documentation was available for a total of 534 patients: 262 in the placebo group and 272 in the adrenaline group. Groups were well matched for baseline characteristics including age, gender and receiving bystander CPR. ROSC occurred in 22 (8.4%) of patients receiving placebo and 64 (23.5%) who received adrenaline (OR=3.4; 95% CI 2.0-5.6). Survival to hospital discharge occurred in 5 (1.9%) and 11 (4.0%) patients receiving placebo or adrenaline respectively (OR=2.2; 95% CI 0.7-6.3). All but two patients (both in the adrenaline group) had a CPC score of 1-2.

CONCLUSION

Patients receiving adrenaline during cardiac arrest had no statistically significant improvement in the primary outcome of survival to hospital discharge although there was a significantly improved likelihood of achieving ROSC.

摘要

背景

尽管几十年来肾上腺素(肾上腺素)一直被认为是心脏骤停治疗的标准治疗方法,但临床试验几乎没有证据表明使用肾上腺素可以提高生存率。我们的研究目的是确定肾上腺素对院外心脏骤停患者出院时生存的影响。

方法

我们进行了一项肾上腺素治疗院外心脏骤停的双盲随机安慰剂对照试验。制备了含有肾上腺素 1:1000 或安慰剂(氯化钠 0.9%)的相同研究小瓶。根据当前的高级生命支持指南,患者被随机分配接受 1 毫升试验药物的等分试样。评估的结果包括出院时的生存率(主要结果)、院前自主循环恢复(ROSC)和神经功能结局(Cerebral Performance Category 评分-CPC)。

结果

在研究期间共筛选了 4103 例心脏骤停病例,其中 601 例进行了随机分组。共有 534 例患者的记录可查:安慰剂组 262 例,肾上腺素组 272 例。两组在基线特征方面匹配良好,包括年龄、性别和接受旁观者心肺复苏术。安慰剂组有 22 例(8.4%)患者发生 ROSC,而接受肾上腺素治疗的患者有 64 例(23.5%)(OR=3.4;95%CI 2.0-5.6)。安慰剂组有 5 例(1.9%)和肾上腺素组有 11 例(4.0%)患者存活至出院(OR=2.2;95%CI 0.7-6.3)。除两名患者(均在肾上腺素组)外,所有患者的 CPC 评分均为 1-2。

结论

尽管接受肾上腺素治疗的心脏骤停患者在主要结局即出院时的生存率方面没有统计学上的显著改善,但 ROSC 的可能性显著提高。

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