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[大学生论坛]:关于新生儿接受血小板输注阈值的随机试验

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蓝色的大海 发表于 2019-1-3 22:11:29 | 显示全部楼层 |阅读模式
Randomized Trial of Platelet-Transfusion Thresholds in Neonates
关于新生儿接受血小板输注阈值的随机试验




Abstract
摘要


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.
背景
血小板输注通常用于预防血小板减少症早产儿患者的出血。为血小板减少症早产婴儿患者输注的预防性血小板存在阈值,而这方面目前尚且缺乏数据资料来提供科学的指导。


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.
研究方法
在此项多中心试验中,我们随机对婴儿进行分组,他们出生前的妊娠期都少于34周,都患有严重血小板减少症,让他们接受血小板输注,血小板数阈值分别为每立方毫米50,000(高阈值组)和每立方毫米25,000(低阈值组)。试验预期用经过验证的出血评估工具记录出血,主要试验结果是随机分配后28天内出现的死亡或大出血案例。



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).
研究结果
我们将660名婴儿(出生体重中位数740克;妊娠期中位数26.6周)进行了随机分组。高阈值组有90%的婴儿,也就是高阈值组328名婴儿中有296名婴儿接受了一次及以上的血小板输注,低阈值组有53%的婴儿,也就是低阈值组331名婴儿中有177名婴儿接受一次及以上的血小板输注。结果表明,高阈值组有26%的婴儿(85名婴儿)、低阈值组有19%的婴儿(61名婴儿)出现了大出血或死亡(优势比1.57; 95%置信区间[CI]1.06 ~ 2.32; P = 0.02)。两组之间在严重不良事件发生率方面无显著差异(高阈值组为25%,低阈值组为22%;优势比1.14; 95%置信区间0.78 ~ 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. (Funded by the National Health Service Blood and Transplant Research and Development Committee and others; Current Controlled Trials number, ISRCTN87736839.)
结论
严重血小板减少症早产婴儿患者在随机分组后,接受血小板计数阈值为每立方毫米50,000的血小板输注的患者在28天内死亡或大出血的概率将明显高于接受血小板计数阈值为每立方毫米25,000的血小板输注的患者。





作者:Anna Curley, M.D., Simon J. Stanworth, F.R.C.P., D.Phil., Karen Willoughby, B.Sc., Susanna F. Fustolo-Gunnink, M.D., Vidheya Venkatesh, M.D., Cara Hudson, M.Sc., Alison Deary, M.Sc., Renate Hodge, M.Sc., Valerie Hopkins, B.Sc., Beatriz Lopez Santamaria, M.Sc., Ana Mora, Ph.D., Charlotte Llewelyn, Ph.D., Angela D’Amore, M.D., Rizwan Khan, M.R.C.P.I., Wes Onland, M.D., Ph.D., Enrico Lopriore, M.D., Ph.D., Karin Fijnvandraat, M.D., Ph.D., Helen New, F.R.C.Path., Ph.D., Paul Clarke, M.D., and Timothy Watts, M.D. for the PlaNeT2 MATISSE Collaborators
期刊名称:The New England Journal of Medicine
发表时间:2018-11-02
DOI: 10.1056/NEJMoa1807320

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