研究方案-实验性外伤性脑损伤中低温的系统回顾和荟萃分析:为什么有希望的动物研究没有在实用的临床试验中得到复制?

T. Hirst, Ralf Watzlawick, J. Rhodes, M. Macleod, P. Andrews
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引用次数: 10

摘要

创伤性脑损伤(TBI)是导致死亡和永久残疾的主要原因。系统性低温治疗,一种用于创伤性脑损伤治疗已有几十年的方法,最近被发现与中性或不利的临床结果相关,尽管临床前研究显然很有希望。系统评价和荟萃分析是一种总结文献和观察实验设计和质量趋势的工具,这些趋势支持其一般结论。在这里,我们的目标是使用这些技术来描述动物TBI模型中低温的使用,整理与结果、研究设计和质量相关的数据。从这里,我们打算观察特征之间的相关性,并试图解释在动物和临床数据之间发现的任何差异。本方案详细描述了相关的方法。
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Study protocol – A systematic review and meta‐analysis of hypothermia in experimental traumatic brain injury: Why have promising animal studies not been replicated in pragmatic clinical trials?
Traumatic brain injury (TBI) is a major cause of death and permanent disability. Systemic hypothermia, a treatment used in TBI for many decades, has recently been found to be associated with neutral or unfavourable clinical outcomes despite apparently promising preclinical research. Systematic review and meta‐analysis is a tool to summarize literature and observe trends in experimental design and quality that underpin its general conclusions. Here we aim to use these techniques to describe the use of hypothermia in animal TBI models, collating data relating to outcome and both study design and quality. From here we intend to observe correlations between features and attempt to explain any discrepancies found between animal and clinical data. This protocol describes the relevant methodology in detail.
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