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新生儿血小板输注阈值的随机试验
Randomized Trial of Platelet-Transfusion Thresholds in Neonates


Anna Curley ... 妇产科和儿科 • 2019.01.17
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• 病例4-2018:一名出现血小板减少、白内障和肝脾大的新生儿

应对早产新生儿血小板减少,传统输血阈值弊大于利

 

胡黎园,周文浩*

复旦大学附属儿科医院新生儿科

*通讯作者

 

新生儿血小板减少症(neonatal thrombocytopenia,NTP)是新生儿常见的出血性疾病,其发病率占所有新生儿的1%~5%1,但在早产儿中发病率可高达20%~35%2,3。文献报道,孕周越小、体重越低、病情越危重的新生儿,发生重度血小板减少的比例越高。有数据显示,在新生儿重症监护治疗病房(neonatal intensive care unit,NICU)发生重度血小板减少者达2.4%~5.0%3,4,出生体重<1,000g的超低出生体重儿在生后3日内发生重度血小板减少者可高达28%5

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摘要


背景

血小板输注通常用于预防患血小板减少症的早产儿发生出血。对于患重度血小板减少症的早产新生儿,目前缺乏指导预防性血小板输注阈值的数据。

 

方法

在这项多中心试验中,我们将患重度血小板减少症、早于妊娠34周出生的婴儿随机分组,接受血小板计数阈值为50,000/mm3(高阈值组)或25,000/mm3(低阈值组)的血小板输注。使用经过验证的出血评估工具前瞻性地记录出血。主要结局为随机分组后28日内死亡或新发大出血。

 

结果

共有660名婴儿(中位出生体重,740 g;中位孕周,26.6周)被随机分组。在高阈值组中,90%的婴儿(328名婴儿中的296名)接受了至少1次血小板输注,而在低阈值组中,这一比例仅为53%(331名婴儿中的177名)。在高阈值组和低阈值组中,新发大出血或死亡的发生率分别为26%(324名中的85名)和19%(329名中的61名)(比值比,1.57;95%置信区间[CI],1.06~2.32;P=0.02)。两组的严重不良事件发生率无显著差异(高阈值组25%,低阈值组22%;比值比,1.14;95% CI,0.78~1.67)。

 

结论

在患重度血小板减少症的早产儿中,被随机分配至高阈值组(血小板计数阈值50,000/mm3)的早产儿在随机分组后28日内的死亡或大出血发生率显著高于低阈值组(血小板计数阈值25,000/mm3)的早产儿(由英国国家医疗服务体系血液和移植研究与开发委员会[National Health Service Blood and Transplant Research and Development Committee]等资助;在Current Controlled Trials注册号为ISRCTN87736839)。





作者信息

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*
From the Department of Neonatology, National Maternity Hospital, Dublin (A.C.), and University Maternity Hospital Limerick, Limerick (R.K.) — both in Ireland; Department of Transfusion Medicine, National Health Service (NHS) Blood and Transplant, the Department of Haematology, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, the Radcliffe Department of Medicine, University of Oxford, and Oxford Biomedical Research Centre Haematology Theme, Oxford (S.J.S.), the Department of Obstetrics and Gynaecology, University of Cambridge (K.W.), NHS Blood and Transplant, Clinical Trials Unit (K.W., C.H., A. Deary, R.H., V.H., A.M., C.L.), and the Neonatal Intensive Care Unit, Cambridge University Hospitals NHS Trust (A. D’Amore), Cambridge, the Neonatal Intensive Care Unit, Evelina London Children’s Hospital, Guy’s and St. Thomas’ NHS Foundation Trust (B.L.S., T.W.), NHS Blood and Transplant (H.N.), and the Department of Hematology, Imperial College London (H.N.), London, and the Neonatal Intensive Care Unit, Norfolk and Norwich University Hospitals NHS Foundation Trust, and Norwich Medical School, University of East Anglia, Norwich Research Park, Norwich (P.C.) — all in the United Kingdom; the Center for Clinical Transfusion Research, Sanquin Blood Supply (S.F.F.-G., K.F.), and the Departments of Epidemiology (S.F.F.-G.) and Neonatology (E.L.), Leiden University Medical Center, Leiden, and the Departments of Pediatric Hematology (S.F.F.-G., K.F.) and Neonatology (W.O.), Emma Children’s Hospital, Academic Medical Center, Amsterdam — both in the Netherlands; and the Neonatal Intensive Care Unit, Cloudnine Hospital, Bangalore, India (V.V.). Address reprint requests to Dr. Curley at the Department of Neonatology, National Maternity Hospital, Holles St., Dublin 2, Ireland, or at acurley@nmh.ie. *A complete list of the PlaNeT2 MATISSE investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

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