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急性肾损伤临床试验设计:老问题,新策略。

Acute kidney injury clinical trial design: old problems, new strategies.

机构信息

Christchurch Kidney Research Group, Department of Medicine, University of Otago, Christchurch, New Zealand.

出版信息

Pediatr Nephrol. 2013 Feb;28(2):207-17. doi: 10.1007/s00467-012-2171-3. Epub 2012 May 26.

DOI:10.1007/s00467-012-2171-3
PMID:22639043
Abstract

Apart from supportive dialysis there are no universally accepted interventions in acute kidney injury (AKI). We have summarized the outcomes of all published randomized, placebo-controlled studies of non-dialysis treatment of AKI. Forty-nine trials were identified, only one of which was in a paediatric population. Sixteen trials had positive outcomes; these trials are not comparable in terms of methodology used or outcomes assessed, and they share many of the problems of the negative trials. We discuss the flaws in clinical trial design that have contributed to poor or uncertain outcomes and propose minimum requirements for future trials. In particular, future trials should incorporate biomarkers specific to the etiology of the AKI, and treatment should match the phase of injury.

摘要

除了支持性透析外,急性肾损伤(AKI)目前并没有被普遍认可的干预措施。我们总结了所有已发表的非透析治疗 AKI 的随机、安慰剂对照研究的结果。共确定了 49 项试验,其中只有 1 项是儿科人群。16 项试验有阳性结果;这些试验在所用方法或评估结果方面无法进行比较,而且它们与阴性试验有许多共同的问题。我们讨论了导致不良或不确定结果的临床试验设计缺陷,并为未来的试验提出了最低要求。特别是,未来的试验应该纳入与 AKI 病因特异性的生物标志物,且治疗应与损伤阶段相匹配。

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本文引用的文献

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Section 2: AKI Definition.第2节:急性肾损伤的定义。
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Some biomarkers of acute kidney injury are increased in pre-renal acute injury.有些急性肾损伤的生物标志物在肾前性急性损伤中增加。
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Linking injury to outcome in acute kidney injury: a matter of sensitivity.将损伤与急性肾损伤的结局联系起来:敏感性问题。
PLoS One. 2013 Apr 23;8(4):e62691. doi: 10.1371/journal.pone.0062691. Print 2013.
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4
Septic acute kidney injury: hemodynamic syndrome, inflammatory disorder, or both?脓毒症急性肾损伤:血流动力学综合征、炎症紊乱,还是两者兼有?
Crit Care. 2011;15(6):1008. doi: 10.1186/cc10525. Epub 2011 Nov 18.
5
Test characteristics of urinary biomarkers depend on quantitation method in acute kidney injury.尿液生物标志物的检测特性取决于急性肾损伤的定量方法。
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6
Cellular pathophysiology of ischemic acute kidney injury.缺血性急性肾损伤的细胞病理生理学。
J Clin Invest. 2011 Nov;121(11):4210-21. doi: 10.1172/JCI45161. Epub 2011 Nov 1.
7
Unveiling current controversies in acute kidney injury.揭示急性肾损伤当前的争议问题。
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Septic acute kidney injury: the culprit is inflammatory apoptosis rather than ischemic necrosis.脓毒症急性肾损伤:罪魁祸首是炎症性细胞凋亡而非缺血性坏死。
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