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创伤性脑损伤的当前临床试验

Current Clinical Trials in Traumatic Brain Injury.

作者信息

Ahmed Zubair

机构信息

Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.

Centre for Trauma Sciences Research, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.

出版信息

Brain Sci. 2022 Apr 21;12(5):527. doi: 10.3390/brainsci12050527.

Abstract

Traumatic brain injury (TBI) is one of the leading causes of morbidity, disability and mortality across all age groups globally. Currently, only palliative treatments exist, but these are suboptimal and do little to combat the progressive damage to the brain that occurs after a TBI. However, multiple experimental treatments are currently available that target the primary and secondary biochemical and cellular changes that occur after a TBI. Some of these drugs have progressed to clinical trials and are currently being evaluated for their therapeutic benefits in TBI patients. The aim of this study was to identify which drugs are currently being evaluated in clinical trials for TBI. A search of ClinicalTrials.gov was performed on 3 December 2021 and all clinical trials that mentioned "TBI" OR "traumatic brain injury" AND "drug" were searched, revealing 362 registered trials. Of the trials, 46 were excluded due to the drug not being mentioned, leaving 138 that were completed and 116 that were withdrawn. Although the studies included 267,298 TBI patients, the average number of patients per study was 865 with a range of 5-200,000. Of the completed studies, 125 different drugs were tested in TBI patients but only 7 drugs were used in more than three studies, including amantadine, botulinum toxin A and tranexamic acid (TXA). However, previous clinical studies using these seven drugs showed variable results. The current study concludes that clinical trials in TBI have to be carefully conducted so as to reduce variability across studies, since the severity of TBI and timing of therapeutic interventions were key aspects of trial success.

摘要

创伤性脑损伤(TBI)是全球所有年龄组发病、致残和死亡的主要原因之一。目前,仅有姑息治疗手段,但这些方法并不理想,对TBI后发生的大脑进行性损伤几乎没有作用。然而,目前有多种实验性治疗方法,针对TBI后发生的原发性和继发性生化及细胞变化。其中一些药物已进入临床试验阶段,目前正在评估它们对TBI患者的治疗效果。本研究的目的是确定目前哪些药物正在TBI的临床试验中接受评估。于2021年12月3日在ClinicalTrials.gov上进行了检索,搜索了所有提及“TBI”或“创伤性脑损伤”以及“药物”的临床试验,共发现362项注册试验。在这些试验中,有46项因未提及药物而被排除,剩下138项已完成试验和116项已撤回试验。尽管这些研究纳入了267,298名TBI患者,但每项研究的平均患者数量为865名,范围在5至200,000名之间。在已完成的研究中,有125种不同药物在TBI患者中进行了测试,但只有7种药物在三项以上研究中使用,包括金刚烷胺、肉毒杆菌毒素A和氨甲环酸(TXA)。然而,此前使用这七种药物的临床研究结果不一。本研究得出结论,TBI的临床试验必须谨慎进行,以减少各研究之间的差异,因为TBI的严重程度和治疗干预的时机是试验成功的关键因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7762/9138587/867a7039ce3c/brainsci-12-00527-g001.jpg

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