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[NEJM在线发表]:中高危心脏外科患者的限制性输血策略
2017年11月29日 时讯速递, 进展交流 暂无评论

ORIGINAL ARTICLE

Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery

C. David Mazer, Richard P. Whitlock, Dean A. Fergusson, et al

N Engl J Med 2017 November 12, 2017DOI: 10.1056/NEJMoa1711818

BACKGROUND 背景

The effect of a restrictive versus liberal red-cell transfusion strategy on clinical outcomes in patients undergoing cardiac surgery remains unclear.

限制与自由输血策略对接受心脏外科手术患者临床预后的影响尚不清楚。

 

METHODS 方法

In this multicenter, open-label, noninferiority trial, we randomly assigned 5243 adults undergoing cardiac surgery who had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery) to a restrictive red-cell transfusion threshold (transfuse if hemoglobin level was <7.5 g per deciliter, starting from induction of anesthesia) or a liberal red-cell transfusion threshold (transfuse if hemoglobin level was <9.5 g per deciliter in the operating room or intensive care unit [ICU] or was <8.5 g per deciliter in the non-ICU ward). The primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first. Secondary outcomes included red-cell transfusion and other clinical outcomes.

在这项多中心、开放、非劣效试验中,我们将5243名接受心脏手术且EuroSCORE I评分大于等于6分(评分0-47分,分值越高提示心脏手术后死亡风险越高)的成年患者随机分组,包括限制输血(从麻醉诱导开始,血红蛋白< 7.5 g/dl时输血)或自由输血组(在手术室或ICU中,血红蛋白< 9.5 g/dl时输血;在非ICU病房血红蛋白< 8.5 g/dl时输血)。主要终点为出院或28天内全因死亡,心肌梗塞,卒中或新发肾功能衰竭需要透析治疗。次要终点包括输血及其他临床预后。

RESULTS 结果

The primary outcome occurred in 11.4% of the patients in the restrictive-threshold group, as compared with 12.5% of those in the liberal-threshold group (absolute risk difference, −1.11 percentage points; 95% confidence interval [CI], −2.93 to 0.72; odds ratio, 0.90; 95% CI, 0.76 to 1.07; P<0.001 for noninferiority). Mortality was 3.0% in the restrictive-threshold group and 3.6% in the liberal-threshold group (odds ratio, 0.85; 95% CI, 0.62 to 1.16). Red-cell transfusion occurred in 52.3% of the patients in the restrictive-threshold group, as compared with 72.6% of those in the liberal-threshold group (odds ratio, 0.41; 95% CI, 0.37 to 0.47). There were no significant between-group differences with regard to the other secondary outcomes.

限制输血组11.4%及自由输血组12.5%的患者发生主要预后终点(绝对风险差异, −1.11%; 95% 可信区间 [CI], −2.93 to 0.72; 比数比, 0.90; 95% CI, 0.76 to 1.07; 非劣效P < 0.001)。限制输血组病死率3.0%,自由输血组为3.6%(比数比,0.85; 95% CI, 0.62 to 1.16)。限制输血组52.3%的患者接受输血,自由输血组为72.6%(比数比, 0.41; 95% CI, 0.37 to 0.47)。其他次要预后终点没有显著的组间差异。

CONCLUSIONS 结论

In patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive strategy regarding red-cell transfusion was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis, with less blood transfused. (Funded by the Canadian Institutes of Health Research and others; TRICS III ClinicalTrials.gov number, NCT02042898.)

在接受心脏手术的死亡中高危患者,在全因死亡、心肌梗塞,卒中或需要透析治疗的新发肾功能衰竭方面,限制输血策略并不劣于自由输血策略,且减少输血。

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