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肾上腺素(epinephrine)实际给予与未给予的结局 - 一项随机临床试验的事后分析。

Outcome when adrenaline (epinephrine) was actually given vs. not given - post hoc analysis of a randomized clinical trial.

机构信息

Department of Anaesthesiology and Institute for Experimental Medical Research, Oslo University Hospital, PB 4956 Nydalen, N-0424 Oslo, Norway.

出版信息

Resuscitation. 2012 Mar;83(3):327-32. doi: 10.1016/j.resuscitation.2011.11.011. Epub 2011 Nov 22.

Abstract

PURPOSE OF THE STUDY

IV line insertion and drugs did not affect long-term survival in an out-of-hospital cardiac arrest (OHCA) randomized clinical trial (RCT). In a previous large registry study adrenaline was negatively associated with survival from OHCA. The present post hoc analysis on the RCT data compares outcomes for patients actually receiving adrenaline to those not receiving adrenaline.

MATERIALS AND METHODS

Patients from a RCT performed May 2003 to April 2008 were included. Three patients from the original intention-to-treat analysis were excluded due to insufficient documentation of adrenaline administration. Quality of cardiopulmonary resuscitation (CPR) and clinical outcomes were compared.

RESULTS

Clinical characteristics were similar and CPR quality comparable and within guideline recommendations for 367 patients receiving adrenaline and 481 patients not receiving adrenaline. Odds ratio (OR) for being admitted to hospital, being discharged from hospital and surviving with favourable neurological outcome for the adrenaline vs. no-adrenaline group was 2.5 (CI 1.9, 3.4), 0.5 (CI 0.3, 0.8) and 0.4 (CI 0.2, 0.7), respectively. Ventricular fibrillation, response interval, witnessed arrest, gender, age and endotracheal intubation were confounders in multivariate logistic regression analysis. OR for survival for adrenaline vs. no-adrenaline adjusted for confounders was 0.52 (95% CI: 0.29, 0.92).

CONCLUSION

Receiving adrenaline was associated with improved short-term survival, but decreased survival to hospital discharge and survival with favourable neurological outcome after OHCA. This post hoc survival analysis is in contrast to the previous intention-to-treat analysis of the same data, but agrees with previous non-randomized registry data. This shows limitations of non-randomized or non-intention-to-treat analyses.

摘要

研究目的

在一项院外心脏骤停(OHCA)的随机临床试验(RCT)中,静脉置管和药物并未影响长期生存率。在之前的一项大型注册研究中,肾上腺素与 OHCA 的生存率呈负相关。本研究对 RCT 数据进行了事后分析,比较了实际接受肾上腺素治疗的患者与未接受肾上腺素治疗的患者的结局。

材料和方法

纳入了 2003 年 5 月至 2008 年 4 月进行的 RCT 患者。由于肾上腺素给药的记录不充分,将原始意向治疗分析中的 3 例患者排除在外。比较了心肺复苏(CPR)质量和临床结局。

结果

接受肾上腺素治疗的 367 例患者和未接受肾上腺素治疗的 481 例患者的临床特征相似,CPR 质量也相似,并且符合指南建议。肾上腺素组与无肾上腺素组相比,住院、出院和幸存且神经功能良好的患者比例的优势比(OR)分别为 2.5(95%CI:1.9,3.4)、0.5(95%CI:0.3,0.8)和 0.4(95%CI:0.2,0.7)。室颤、反应间隔、目击者见证、性别、年龄和气管插管是多变量逻辑回归分析中的混杂因素。调整混杂因素后,肾上腺素组与无肾上腺素组的生存 OR 为 0.52(95%CI:0.29,0.92)。

结论

接受肾上腺素治疗与短期生存率提高相关,但与 OHCA 后出院生存率和幸存且神经功能良好的生存率降低相关。这项事后生存分析与同一数据的原始意向治疗分析结果相反,但与之前的非随机注册数据一致。这表明非随机或非意向治疗分析存在局限性。

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