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[大学生论坛]:新生儿血小板输注阈值的随机试验

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Gavin918 发表于 2019-1-4 09:11:29 | 显示全部楼层 |阅读模式
Randomized Trial of Platelet-Transfusion Thresholds in Neonates
新生儿血小板输注阈值的随机试验


Abstract
Background
Platelet transfusions are commonly used to prevent bleeding in preterm infants with thrombocytopenia. Data are lacking to provide guidance regarding thresholds for prophylactic platelet transfusions in preterm neonates with severe thrombocytopenia.
血小板输注一般用于预防患有血小板减少症的早产儿的出血现象。关于患有严重血小板减少症的早产儿的血小板输注阈值,目前还缺乏相关数据来提供指导。

Methods
In this multicenter trial, we randomly assigned infants born at less than 34 weeks of gestation in whom severe thrombocytopenia developed to receive a platelet transfusion at platelet-count thresholds of 50,000 per cubic millimeter (high-threshold group) or 25,000 per cubic millimeter (low-threshold group). Bleeding was documented prospectively with the use of a validated bleeding-assessment tool. The primary outcome was death or new major bleeding within 28 days after randomization.
在这项多中心试验中,我们随机分配出生低于34周的婴儿,把发生严重血小板减少症的婴儿接受血小板输注血小板计数阈值设为50,000立方毫米(高阈值组)或25,000立方毫米(低阈值组)。借助已经证实的出血评估工具来前瞻性地记录出血情况。主要结果是随机试验后28天内死亡或者新的大出血。

Results
A total of 660 infants (median birth weight, 740 g; and median gestational age, 26.6 weeks) underwent randomization. In the high-threshold group, 90% of the infants (296 of 328 infants) received at least one platelet transfusion, as compared with 53% (177 of 331 infants) in the low-threshold group. A new major bleeding episode or death occurred in 26% of the infants (85 of 324) in the high-threshold group and in 19% (61 of 329) in the low-threshold group (odds ratio, 1.57; 95% confidence interval [CI], 1.06 to 2.32; P=0.02). There was no significant difference between the groups with respect to rates of serious adverse events (25% in the high-threshold group and 22% in the low-threshold group; odds ratio, 1.14; 95% CI, 0.78 to 1.67).
一共有660名婴儿(出生体重中位数为740克;妊娠年龄中位数为26.6周)接受了随机分组。在高阈值组中,90%的婴儿(328名婴儿中的296名)接受了至少一次血小板输注,而相较于低阈值组中有53%的婴儿(331名婴儿中有177名)接受了至少一次血小板输注。在高阈值组中,26%的婴儿(324个中的85名)和低阈值组中的19%(32个中的61名)出现了新的大出血或死亡(优势比为1.57; 95%置信区间,1.06至2.32; P=0.02)。两组在严重不良事件发生率方面并没有明显差异(高阈值组为25%,低阈值组为22%;优势比为1.14; 95%置信区间,0.78至1.67)。

Conclusions
Among preterm infants with severe thrombocytopenia, those randomly assigned to receive platelet transfusions at a platelet-count threshold of 50,000 per cubic millimeter had a significantly higher rate of death or major bleeding within 28 days after randomization than those who received platelet transfusions at a platelet-count threshold of 25,000 per cubic millimeter.
在患有严重血小板减少症的早产儿中,那些被随机分配到接受血小板输注,血小板计数阈值为50,000立方毫米的婴儿在随机分组后28天内死亡率或大出血率明显高于血小板技术阈值为25,000立方毫米的婴儿。

作者:Anna Curley et al
期刊名称:New England Journal of Medicine
发布时间:2018-11-02
DOI: 10.1056/NEJMoa1807320

本文来自:https://www.nejm.org/doi/full/10.1056/NEJMoa1807320



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