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比较多巴胺和肾上腺素用于小儿液体难治性低血压性感染性休克的双盲随机临床试验

Double-Blind Randomized Clinical Trial Comparing Dopamine and Epinephrine in Pediatric Fluid-Refractory Hypotensive Septic Shock.

作者信息

Ramaswamy Karthik Narayanan, Singhi Sunit, Jayashree Muralidharan, Bansal Arun, Nallasamy Karthi

机构信息

All authors: Division of Pediatric Intensive and Emergency Care, Department of Pediatrics, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

Pediatr Crit Care Med. 2016 Nov;17(11):e502-e512. doi: 10.1097/PCC.0000000000000954.

DOI:10.1097/PCC.0000000000000954
PMID:27673385
Abstract

OBJECTIVE

We compared efficacy of dopamine and epinephrine as first-line vasoactive therapy in achieving resolution of shock in fluid-refractory hypotensive cold septic shock.

DESIGN

Double-blind, pilot, randomized controlled study.

SETTING

Pediatric emergency and ICU of a tertiary care teaching hospital.

PATIENTS

Consecutive children 3 months to 12 years old, with fluid-refractory hypotensive septic shock, were enrolled between July 2013 and December 2014.

INTERVENTION

Enrolled children were randomized to receive either dopamine (in incremental doses, 10 to 15 to 20 μg/kg/min) or epinephrine (0.1 to 0.2 to 0.3 μg/kg/min) till end points of resolution of shock were achieved. After reaching maximum doses of test drugs, open-label vasoactive was started as per discretion of treating team. Primary outcome was resolution of shock within first hour of resuscitation. The study was registered (CTRI/2014/02/004393) and was approved by institute ethics committee.

MEASUREMENTS AND MAIN RESULTS

We enrolled 29 children in epinephrine group and 31 in dopamine group. Resolution of shock within first hour was achieved in greater proportion of children receiving epinephrine (n = 12; 41%) than dopamine (n = 4; 13%) (odds ratio, 4.8; 95% CI, 1.3-17.2; p = 0.019); the trend persisted even at 6 hours (48.3% vs 29%; p = 0.184). Children in epinephrine group had lower Sequential Organ Function Assessment score on day 3 (8 vs 12; p = 0.05) and more organ failure-free days (24 vs 20 d; p = 0.022). No significant difference in adverse events (16.1% vs 13.8%; p = 0.80) and mortality (58.1% vs 48.3%; p = 0.605) was observed between the two groups.

CONCLUSION

Epinephrine is more effective than dopamine in achieving resolution of fluid-refractory hypotensive cold shock within the first hour of resuscitation and improving organ functions.

摘要

目的

我们比较了多巴胺和肾上腺素作为一线血管活性药物治疗对液体难治性低血压性冷休克患儿休克缓解的疗效。

设计

双盲、前瞻性、随机对照研究。

地点

一家三级医疗教学医院的儿科急诊科和重症监护病房。

患者

2013年7月至2014年12月期间,连续纳入3个月至12岁、患有液体难治性低血压性脓毒性休克的儿童。

干预措施

将纳入的儿童随机分为两组,分别接受多巴胺(递增剂量,10至15至20μg/kg/min)或肾上腺素(0.1至0.2至0.3μg/kg/min)治疗,直至休克缓解的终点指标达成。在达到试验药物的最大剂量后,根据治疗团队的判断开始使用开放标签的血管活性药物。主要结局指标是复苏后第一小时内休克缓解情况。本研究已注册(CTRI/2014/02/004393)并获得机构伦理委员会批准。

测量指标及主要结果

我们纳入了肾上腺素组29名儿童和多巴胺组31名儿童。接受肾上腺素治疗的儿童中,在复苏后第一小时内休克缓解的比例(n = 12;41%)高于接受多巴胺治疗的儿童(n = 4;13%)(优势比,4.8;95%CI,1.3 - 17.2;p = 0.019);即使在6小时时这一趋势仍持续存在(48.3%对29%;p = 0.184)。肾上腺素组儿童在第3天的序贯器官功能评估评分更低(8分对12分;p = 0.05),且无器官衰竭天数更多(24天对20天;p = 0.022)。两组之间在不良事件(16.1%对13.8%;p = 0.80)和死亡率(58.1%对48.3%;p = 0.605)方面未观察到显著差异。

结论

在复苏后第一小时内,肾上腺素在实现液体难治性低血压性冷休克缓解及改善器官功能方面比多巴胺更有效。

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