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相互矛盾的临床试验数据:白蛋白带来的教训。

Conflicting clinical trial data: a lesson from albumin.

作者信息

Martin Greg

机构信息

Division of Pulmonary, Allergy and Critical Care, Emory University School of Medicine, Atlanta, Georgia, USA.

出版信息

Crit Care. 2005;9(6):649-50. doi: 10.1186/cc3931. Epub 2005 Nov 22.

DOI:10.1186/cc3931
PMID:16356259
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1414029/
Abstract

Albumin is a frequently prescribed drug in hospitalized patients, and its effect on clinical outcomes has been scrutinized in recent years. Data from meta-analyses has suggested harm related to albumin therapy in critically ill patients, and new observational data are consistent with these results. However, appropriately powered randomized, controlled trials have shown albumin to be safe in broad groups of critically ill patients. This article will discuss the reasons for differences between observational and controlled trial data, and the implications for future albumin use and clinical research.

摘要

白蛋白是住院患者常用的处方药,近年来其对临床结局的影响受到了仔细审查。荟萃分析的数据表明,白蛋白治疗对重症患者有危害,新的观察性数据也与这些结果一致。然而,有充分统计学效力的随机对照试验表明,白蛋白在广大重症患者群体中是安全的。本文将讨论观察性数据与对照试验数据存在差异的原因,以及对未来白蛋白使用和临床研究的影响。

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引用本文的文献

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Meta-analyses of adverse effects data derived from randomised controlled trials as compared to observational studies: methodological overview.随机对照试验与观察性研究中不良反应数据的荟萃分析:方法学概述。
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2
In neonates requiring intravascular volume resuscitation is the use of gelofusine safe and efficacious?对于需要进行血管内容量复苏的新生儿,使用琥珀酰明胶是否安全有效?
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本文引用的文献

1
Is albumin administration in the acutely ill associated with increased mortality? Results of the SOAP study.急性病患者使用白蛋白是否会增加死亡率?SOAP研究结果。
Crit Care. 2005;9(6):R745-54. doi: 10.1186/cc3895. Epub 2005 Nov 7.
2
Albumin: biochemical properties and therapeutic potential.白蛋白:生化特性与治疗潜力。
Hepatology. 2005 Jun;41(6):1211-9. doi: 10.1002/hep.20720.
3
Evidence-based colloid use in the critically ill: American Thoracic Society Consensus Statement.危重症患者基于证据的胶体使用:美国胸科学会共识声明
Am J Respir Crit Care Med. 2004 Dec 1;170(11):1247-59. doi: 10.1164/rccm.200208-909ST.
4
A comparison of albumin and saline for fluid resuscitation in the intensive care unit.重症监护病房中白蛋白与生理盐水用于液体复苏的比较。
N Engl J Med. 2004 May 27;350(22):2247-56. doi: 10.1056/NEJMoa040232.
5
Randomized, controlled trials, observational studies, and the hierarchy of research designs.随机对照试验、观察性研究以及研究设计的层次结构。
N Engl J Med. 2000 Jun 22;342(25):1887-92. doi: 10.1056/NEJM200006223422507.
6
A comparison of observational studies and randomized, controlled trials.观察性研究与随机对照试验的比较。
N Engl J Med. 2000 Jun 22;342(25):1878-86. doi: 10.1056/NEJM200006223422506.
7
Human albumin administration in critically ill patients: systematic review of randomised controlled trials.危重症患者使用人白蛋白:随机对照试验的系统评价
BMJ. 1998 Jul 25;317(7153):235-40. doi: 10.1136/bmj.317.7153.235.
8
Fluid resuscitation with colloid or crystalloid solutions in critically ill patients: a systematic review of randomised trials.危重症患者使用胶体液或晶体液进行液体复苏:随机试验的系统评价
BMJ. 1998 Mar 28;316(7136):961-4. doi: 10.1136/bmj.316.7136.961.
9
Discrepancies between meta-analyses and subsequent large randomized, controlled trials.荟萃分析与随后的大型随机对照试验之间的差异。
N Engl J Med. 1997 Aug 21;337(8):536-42. doi: 10.1056/NEJM199708213370806.
10
Randomized versus historical controls for clinical trials.临床试验中的随机对照与历史对照
Am J Med. 1982 Feb;72(2):233-40. doi: 10.1016/0002-9343(82)90815-4.