促红细胞生成素治疗创伤性脑损伤相关急性肾损伤：一项随机对照试验。

Erythropoietin in traumatic brain injury associated acute kidney injury: A randomized controlled trial.

机构信息

Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.

Division of Intensive Care, Department of Anaesthesiology, Intensive Care and Pain Medicine, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.

出版信息

Acta Anaesthesiol Scand. 2019 Feb;63(2):200-207. doi: 10.1111/aas.13244. Epub 2018 Aug 21.

DOI:10.1111/aas.13244

PMID:30132785

Abstract

BACKGROUND

Acute kidney injury (AKI) in traumatic brain injury (TBI) is poorly understood and it is unknown if it can be attenuated using erythropoietin (EPO).

METHODS

Pre-planned analysis of patients included in the EPO-TBI (ClinicalTrials.gov NCT00987454) trial who were randomized to weekly EPO (40 000 units) or placebo (0.9% sodium chloride) subcutaneously up to three doses or until intensive care unit (ICU) discharge. Creatinine levels and urinary output (up to 7 days) were categorized according to the Kidney Disease Improving Global Outcome (KDIGO) classification. Severity of TBI was categorized with the International Mission for Prognosis and Analysis of Clinical Trials in TBI.

RESULTS

Of 3348 screened patients, 606 were randomized and 603 were analyzed. Of these, 82 (14%) patients developed AKI according to KDIGO (60 [10%] with KDIGO 1, 11 [2%] patients with KDIGO 2, and 11 [2%] patients with KDIGO 3). Male gender (hazard ratio [HR] 4.0 95% confidence interval [CI] 1.4-11.2, P = 0.008) and severity of TBI (HR 1.3 95% CI 1.1-1.4, P < 0.001 for each 10% increase in risk of poor 6 month outcome) predicted time to AKI. KDIGO stage 1 (HR 8.8 95% CI 4.5-17, P < 0.001), KDIGO stage 2 (HR 13.2 95% CI 3.9-45.2, P < 0.001) and KDIGO stage 3 (HR 11.7 95% CI 3.5-39.7, P < 0.005) predicted time to mortality. EPO did not influence time to AKI (HR 1.08 95% CI 0.7-1.67, P = 0.73) or creatinine levels during ICU stay (P = 0.09).

CONCLUSIONS

Acute kidney injury is more common in male patients and those with severe compared to moderate TBI and appears associated with worse outcome. EPO does not prevent AKI after TBI.

摘要

背景

外伤性脑损伤（TBI）患者的急性肾损伤（AKI）机制尚不清楚，也不确定促红细胞生成素（EPO）是否能减轻其损伤。

方法

对 EPO-TBI（ClinicalTrials.gov NCT00987454）试验中纳入的患者进行了预先计划的分析，这些患者被随机分配接受每周皮下注射 EPO（40000 单位）或安慰剂（0.9%氯化钠），最多 3 剂或直至重症监护病房（ICU）出院。根据肾脏疾病改善全球结局（KDIGO）分类，对肌酐水平和尿排量（最多 7 天）进行分类。TBI 的严重程度采用国际创伤预后分析临床试验分类进行分类。

结果

在筛选的 3348 名患者中，有 606 名被随机分配，有 603 名患者接受了分析。其中，82 名（14%）患者根据 KDIGO 标准发生 AKI（60 名[10%]为 KDIGO 1 期，11 名[2%]为 KDIGO 2 期，11 名[2%]为 KDIGO 3 期）。男性（危险比[HR]4.0，95%置信区间[CI]1.4-11.2，P=0.008）和 TBI 严重程度（HR 1.3，95%CI 1.1-1.4，每增加 10%不良 6 个月结局风险，P<0.001）预测 AKI 发生时间。KDIGO 1 期（HR 8.8，95%CI 4.5-17，P<0.001）、KDIGO 2 期（HR 13.2，95%CI 3.9-45.2，P<0.001）和 KDIGO 3 期（HR 11.7，95%CI 3.5-39.7，P<0.005）预测死亡率发生时间。EPO 对 AKI 发生时间（HR 1.08，95%CI 0.7-1.67，P=0.73）或 ICU 期间的肌酐水平（P=0.09）没有影响。