Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.
Department of Neurosurgery, University of Pecs, Pecs, Hungary.
J Neurotrauma. 2021 Apr 15;38(8):1086-1106. doi: 10.1089/neu.2017.5182. Epub 2018 Jul 2.
Accurate diagnosis of traumatic brain injury (TBI) is critical to effective management and intervention, but can be challenging in patients with mild TBI. A substantial number of studies have reported the use of circulating biomarkers as signatures for TBI, capable of improving diagnostic accuracy and clinical decision making beyond current practice standards. We performed a systematic review and meta-analysis to comprehensively and critically evaluate the existing body of evidence for the use of blood protein biomarkers (S100 calcium binding protein B [S100B], glial fibrillary acidic protein [GFAP], neuron specific enolase [NSE], ubiquitin C-terminal hydrolase-L1 [UCH-L1]. tau, and neurofilament proteins) for diagnosis of intracranial lesions on CT following mild TBI. Effects of potential confounding factors and differential diagnostic performance of the included markers were explored. Further, appropriateness of study design, analysis, quality, and demonstration of clinical utility were assessed. Studies published up to October 2016 were identified through searches of MEDLINE, Embase, EBM Reviews, the Cochrane Library, World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP), and clinicaltrials.gov. Following screening of the identified articles, 26 were selected as relevant. We found that measurement of S100B can help informed decision making in the emergency department, possibly reducing resource use; however, there is insufficient evidence that any of the other markers is ready for clinical application. Our work pointed out serious problems in the design, analysis, and reporting of many of the studies, and identified substantial heterogeneity and research gaps. These findings emphasize the importance of methodologically rigorous studies focused on a biomarker's intended use, and defining standardized, validated, and reproducible approaches. The living nature of this systematic review, which will summarize key updated information as it becomes available, can inform and guide future implementation of biomarkers in the clinical arena.
准确诊断创伤性脑损伤（TBI）对于有效管理和干预至关重要，但在轻度 TBI 患者中可能具有挑战性。大量研究报告了使用循环生物标志物作为 TBI 标志物的特征，能够提高诊断准确性，并超越当前实践标准的临床决策。我们进行了系统评价和荟萃分析，以全面和批判性地评估现有的证据，用于使用血液蛋白生物标志物（S100 钙结合蛋白 B [S100B]，神经胶质纤维酸性蛋白 [GFAP]，神经元特异性烯醇化酶 [NSE]，泛素 C 端水解酶-L1 [UCH-L1]。tau 和神经丝蛋白）诊断轻度 TBI 后 CT 上的颅内病变。探讨了潜在混杂因素的影响和纳入标志物的差异诊断性能。此外，还评估了研究设计、分析、质量和临床实用性的适当性。通过对 MEDLINE、Embase、EBM Reviews、Cochrane 图书馆、世界卫生组织（WHO）、国际临床试验注册平台（ICTRP）和 clinicaltrials.gov 的搜索，确定了截至 2016 年 10 月发表的研究。在筛选确定的文章后，选择了 26 篇作为相关文章。我们发现，S100B 的测量可以帮助在急诊室做出明智的决策，可能减少资源的使用；然而，没有足够的证据表明其他任何标志物都已准备好用于临床应用。我们的工作指出了许多研究在设计、分析和报告方面存在的严重问题，并确定了存在很大的异质性和研究空白。这些发现强调了针对生物标志物预期用途进行方法学严格研究的重要性，并确定了标准化、验证和可重复的方法。本系统评价的实时性质，将在有新信息时总结关键更新信息，可为未来在临床领域实施生物标志物提供信息和指导。
