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[NEJM最新论文]:心脏术后限制或自由输血的6个月预后
2018年10月13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 2018; 379:1224-1233

DOI: 10.1056/NEJMoa1808561

Abstract

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.

我们曾经报告,对于接受心脏手术的死亡中高危患者,与自由输血策略相比,限制性输血策略的复合预后终点(住院期间或术后28天内全因死亡,心梗,卒中,或新发肾功能衰竭且需要透析治疗)并未显示劣效。我们现在报告术后6个月的临床预后。

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(若术中或术后血红蛋白< 7.5 g/dl即输血)或自由输血策略(若术中或术后在ICU住院期间血红蛋白< 9.5 g/dl,或术后在普通病房住院期间血红蛋白< 8.5 g/dl即输血)。主要预后终点为复合终点,即术后6个月内全因死亡,心梗,卒中,或新发肾脏功能衰竭需要透析治疗。扩大的次要复合预后终点包括主要预后终点的所有项目,以及术后6个月内急诊就诊,再次住院或冠脉血管重建。次要预后终点包括两个复合终点指标中的各个项目。

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,限制性输血策略组2317名患者中402名(17.4%)以及自由输血组2347名患者中402名 (17.1%)发生主要预后终点事件(凑整前绝对风险差异,0.22百分点;95% 可信区间 [CI], −1.95 to 2.39; 比数比, 1.02; 95% CI, 0.87 to 1.18; 非劣效检验 P=0.006)。限制性输血组病死率6.2%,自由输血组为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.

对于接受心脏手术的死亡中高危患者,在复合预后终点(术后6个月内全因死亡,心梗,卒中,或新发肾功能衰竭需要透析治疗)方面,限制性输血策略与自由输血策略相比并非劣效。

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

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