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血管加压素治疗严重创伤性脑损伤患者脑灌注压管理的随机对照试验初步结果。

Vasopressin for cerebral perfusion pressure management in patients with severe traumatic brain injury: preliminary results of a randomized controlled trial.

机构信息

From the Dewitt-Daughtry Family Department of Surgery and Department of Neurosurgery, University of Miami Miller School of Medicine, Ryder Trauma Center, Miami, Florida.

出版信息

J Trauma Acute Care Surg. 2013 Dec;75(6):1024-30; discussion 1030. doi: 10.1097/TA.0b013e3182a99d48.

Abstract

BACKGROUND

After traumatic brain injury (TBI), catecholamines (CAs) may be needed to maintain adequate cerebral perfusion pressure (CPP), but there are no recommended alternative vasopressor therapies. This is an interim report of the first study to test the hypothesis that arginine vasopressin (AVP) is a safe and effective alternative to CAs for the management of CPP in patients with severe TBI.

METHODS

Since 2008, all TBI patients requiring intracranial pressure monitoring at this Level 1 trauma center have been eligible for a randomized trial to receive either CA or AVP if vasopressors were required to maintain CPP greater than 60 mm Hg.

RESULTS

To date, 96 patients have been consented and randomized. Demographics, vital signs, and laboratory values were similar. As treated, 60 required no vasopressors and were the least severely injured group with the best outcomes. Twenty-three patients received CA (70% levophed, 22% dopamine, 9% phenylephrine) and 12 patients received AVP. The two vasopressor groups had similar demographics, but Injury Severity Score (ISS) and fluid requirements on intensive care unit Day 1 were worse in the AVP versus the CA groups (all p < 0.05) before treatment. These differences indicate more severe injury with accompanying hemodynamic instability. Nevertheless, adverse events were not increased with AVP versus CA. Trends favored AVP versus CA, but no apparent differences were statistically significant at this interim point. There was no difference in mortality rates between CA and AVP.

CONCLUSION

These preliminary results suggest that AVP is a safe and effective alternative to CA for the management of CPP after TBI and support the continued investigation and use of AVP when vasopressors are required for CPP management in TBI patients.

LEVEL OF EVIDENCE

Therapeutic study, level II.

摘要

背景

颅脑损伤(TBI)后,可能需要儿茶酚胺(CAs)来维持足够的脑灌注压(CPP),但目前尚无推荐的替代血管加压药物治疗方法。这是第一项研究的中期报告,该研究旨在检验血管加压素(AVP)作为 CAs 的替代药物,用于治疗严重 TBI 患者 CPP 的假设。

方法

自 2008 年以来,本 1 级创伤中心所有需要颅内压监测的 TBI 患者,如果需要升压药来维持 CPP 大于 60mmHg,则有资格参加一项随机试验,接受 CA 或 AVP 治疗。

结果

迄今为止,已同意并随机分配了 96 名患者。患者的人口统计学、生命体征和实验室值相似。在接受治疗的患者中,60 名患者无需使用升压药,他们是受伤程度最轻、预后最好的一组。23 名患者接受 CA(70%左苯福林、22%多巴胺、9%苯肾上腺素)治疗,12 名患者接受 AVP 治疗。两组血管加压素患者的人口统计学特征相似,但 AVP 组的损伤严重程度评分(ISS)和 ICU 第 1 天的液体需求均高于 CA 组(所有 p<0.05)。这些差异表明,损伤更严重,伴有血流动力学不稳定。尽管如此,AVP 组与 CA 组的不良事件发生率没有增加。AVP 组的趋势优于 CA 组,但在这个中期结果中,没有明显的统计学差异。CA 组和 AVP 组的死亡率无差异。

结论

这些初步结果表明,AVP 是 TBI 后 CPP 管理中 CA 的一种安全有效的替代药物,并支持在 TBI 患者需要 CPP 管理时继续使用 AVP 进行研究和应用。

证据等级

治疗性研究,二级。

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