儿科重症监护病房患者的输血策略。

Transfusion strategies for patients in pediatric intensive care units.

作者信息

Lacroix Jacques, Hébert Paul C, Hutchison James S, Hume Heather A, Tucci Marisa, Ducruet Thierry, Gauvin France, Collet Jean-Paul, Toledano Baruch J, Robillard Pierre, Joffe Ari, Biarent Dominique, Meert Kathleen, Peters Mark J

机构信息

Université de Montréal, Montreal, Canada.

出版信息

N Engl J Med. 2007 Apr 19;356(16):1609-19. doi: 10.1056/NEJMoa066240.

DOI:10.1056/NEJMoa066240

PMID:17442904

Abstract

BACKGROUND

The optimal hemoglobin threshold for erythrocyte transfusions in critically ill children is unknown. We hypothesized that a restrictive transfusion strategy of using packed red cells that were leukocyte-reduced before storage would be as safe as a liberal transfusion strategy, as judged by the outcome of multiple-organ dysfunction.

METHODS

In this noninferiority trial, we enrolled 637 stable, critically ill children who had hemoglobin concentrations below 9.5 g per deciliter within 7 days after admission to an intensive care unit. We randomly assigned 320 patients to a hemoglobin threshold of 7 g per deciliter for red-cell transfusion (restrictive-strategy group) and 317 patients to a threshold of 9.5 g per deciliter (liberal-strategy group).

RESULTS

Hemoglobin concentrations were maintained at a mean (+/-SD) level that was 2.1+/-0.2 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group (lowest average levels, 8.7+/-0.4 and 10.8+/-0.5 g per deciliter, respectively; P<0.001). Patients in the restrictive-strategy group received 44% fewer transfusions; 174 patients (54%) in that group did not receive any transfusions, as compared with 7 patients (2%) in the liberal-strategy group (P<0.001). New or progressive multiple-organ dysfunction syndrome (the primary outcome) developed in 38 patients in the restrictive-strategy group, as compared with 39 in the liberal-strategy group (12% in both groups) (absolute risk reduction with the restrictive strategy, 0.4%; 95% confidence interval, -4.6 to 5.4). There were 14 deaths in each group within 28 days after randomization. No significant differences were found in other outcomes, including adverse events.

CONCLUSIONS

In stable, critically ill children a hemoglobin threshold of 7 g per deciliter for red-cell transfusion can decrease transfusion requirements without increasing adverse outcomes. (Controlled-trials.com number, ISRCTN37246456 [controlled-trials.com].).

摘要

背景

危重症儿童红细胞输血的最佳血红蛋白阈值尚不清楚。我们假设，与宽松输血策略相比，采用储存前白细胞滤除的浓缩红细胞的限制性输血策略在多器官功能障碍的结局方面同样安全。

方法

在这项非劣效性试验中，我们纳入了637名病情稳定的危重症儿童，这些儿童在入住重症监护病房后7天内血红蛋白浓度低于9.5g/dL。我们将320例患者随机分配至红细胞输血血红蛋白阈值为7g/dL的组（限制性策略组），317例患者随机分配至阈值为9.5g/dL的组（宽松策略组）。

结果

限制性策略组的血红蛋白浓度维持在平均（±标准差）水平，比宽松策略组低2.1±0.2g/dL（最低平均水平分别为8.7±0.4和10.8±0.5g/dL；P<0.001）。限制性策略组的患者输血次数减少44%；该组174例患者（54%）未接受任何输血，而宽松策略组为7例患者（2%）（P<0.001）。限制性策略组有38例患者发生新的或进展性多器官功能障碍综合征（主要结局），宽松策略组为39例（两组均为12%）（限制性策略的绝对风险降低率为0.4%；95%置信区间为-4.6至5.4）。随机分组后28天内每组均有14例死亡。在包括不良事件在内的其他结局方面未发现显著差异。