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[NEJM在线发表]:心脏外科手术限制与自由输血对6个月预后的影响
2018年08月31日 时讯速递, 进展交流 暂无评论

ORIGINAL ARTICLE

Six-Month Outcomes after Restrictive or Liberal Transfusion for Cardiac Surgery

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

N Engl J Med August 26, 2018

DOI: 10.1056/NEJMoa1808561

BACKGROUND 背景

We reported previously that, in patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive transfusion strategy 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 by hospital discharge or 28 days after surgery, whichever came first. We now report the clinical outcomes at 6 months after surgery.

我们既往报告,对于中高度死亡风险的心脏手术患者,限制输血策略对于出院时或术后28天的复合预后终点(全因死亡,心肌梗塞,卒中,或新发需要透析治疗的肾功能衰竭)的影响不劣于自由输血策略。我们现在报告术后6个月的临床预后情况。

METHODS 方法

We randomly assigned 5243 adults undergoing cardiac surgery to a restrictive red-cell transfusion strategy (transfusion if the hemoglobin concentration was <7.5 g per deciliter intraoperatively or postoperatively) or a liberal red-cell transfusion strategy (transfusion if the hemoglobin concentration was <9.5 g per deciliter intraoperatively or postoperatively when the patient was in the intensive care unit [ICU] or was <8.5 g per deciliter when the patient was in the non-ICU ward). The primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis occurring within 6 months after the initial surgery. An expanded secondary composite outcome included all the components of the primary outcome as well as emergency department visit, hospital readmission, or coronary revascularization occurring within 6 months after the index surgery. The secondary outcomes included the individual components of the two composite outcomes.

我们将接受心脏手术的5243名成年患者随机分为限制输血策略(当术中或术后血红蛋白< 7.5 g/dL时输血)或自由输血策略(当术中或术后在ICU住院期间血红蛋白< 9.5 g/dL时,或术后在普通病房住院期间血红蛋白< 8.5 g/dL时输血)。主要复合预后终点为术后6个月内任何原因导致的死亡,心肌梗塞,卒中或新发需要透析治疗的肾功能衰竭。扩大的次要复合预后终点包括术后6个月内主要预后终点的所有项目,以及急诊科就诊,再次住院,或冠脉血管重建。次要预后终点包括两个复合预后终点的所有项目。

RESULTS 结果

At 6 months after surgery, the primary composite outcome had occurred in 402 of 2317 patients (17.4%) in the restrictive-threshold group and in 402 of 2347 patients (17.1%) in the liberal-threshold group (absolute risk difference before rounding, 0.22 percentage points; 95% confidence interval [CI], −1.95 to 2.39; odds ratio, 1.02; 95% CI, 0.87 to 1.18; P=0.006 for noninferiority). Mortality was 6.2% in the restrictive-threshold group and 6.4% in the liberal-threshold group (odds ratio, 0.95; 95% CI, 0.75 to 1.21). There were no significant between-group differences in the secondary outcomes.

在术后6个月时,限制阈值组2317名患者中402名(17.4%),以及自由阈值组的2347名患者中402名(17.1%)发生主要复合预后终点(绝对风险差异0.22%;95%CI −1.95 to 2.39; 比数比,1.02;95% CI, 0.87 to 1.18; 非劣效P=0.006)。限制阈值组病死率为 6.2%,自由阈值组病死率为 6.4%(比数比0.95; 95% CI, 0.75 to 1.21)。

CONCLUSIONS 结论

In patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive strategy for 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 at 6 months after surgery.

对于中重度死亡风险的心脏外科手术患者,限制输血策略对于术后6个月复合预后终点(全因死亡,心肌梗塞,卒中,或新发需要透析治疗的肾功能衰竭)的影响不劣于自由输血策略。

(Funded by the Canadian Institutes of Health Research and others; TRICS III ClinicalTrials.gov number, NCT02042898.)

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