Mondello Stefania, Amrein Krisztina, Czeiter Endre, Citerio Giuseppe, Diaz-Arrastia Ramon, Gao Guoyi, Lagares Alfonso, Manley Geoffrey T, Menon David K, Newcombe Virginia, Posti Jussi P, Wilson Lindsay, Zetterberg Henrik, Steyerberg Ewout W, Buki Andras, Maas Andrew I R
Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.
Department of Neurosurgery, Medical School, University of Pécs, Pécs, Hungary.
J Neurotrauma. 2025 May 27. doi: 10.1089/neu.2024.0620.
Circulating biomarkers might improve the prediction of outcomes in patients with traumatic brain injury (TBI) beyond current approaches. Robust and up-to-date evidence is required to support their clinical utility and integration into medical practice to guide decision-making. Our objective was to critically appraise the existing evidence for six core blood-based TBI biomarkers (S100 calcium-binding protein B, glial fibrillary acidic protein [GFAP], neuron-specific enolase, ubiquitin C-terminal hydrolase-L1 [UCH-L1], tau and neurofilament proteins), in predicting outcome after TBI. Electronic databases, including Medline and Embase, were searched for articles published from their inception to October 2023. Studies were included if they evaluated the accuracy of blood biomarker concentrations at hospital presentation for outcome prediction in adult patients with TBI. Outcomes assessed were mortality, Glasgow Outcome Scale (GOS)/GOS extended (GOS-E), or the Rivermead Post-Concussion Symptoms Questionnaire (RPQ). Study selection, data extraction, and quality assessment using the modified Quality Assessment of Prognostic Accuracy Studies tool were performed by two authors independently, with disagreements being resolved through discussion or arbitration. If appropriate, a meta-analysis was conducted by calculating the weighted summary area under the curve (AUC) and using a bivariate regression model. Of 12,792 retrieved records, 32 articles, including 7481 patients with TBI, were selected as relevant. Two biomarkers showed strong associations with in-hospital and 6-month mortality: GFAP (unadjusted pooled AUC 0.81 [95% confidence interval [CI] 0.75-0.87] and 0.82 [0.80-0.85], respectively) and UCH-L1 (0.80 [0.74-0.85] and 0.83 [0.77-0.88]). Their addition to models that included established risk factors consistently improved the predictive value, though models and performance varied substantially across studies. In four studies measuring both markers, UCH-L1 outperformed GFAP in improving risk stratification when added to established prediction models. At ∼1.5 ng/mL (five studies), the summary sensitivity of GFAP for predicting mortality was 78% (95% CI 67-85%), and the summary specificity was 79% (95% CI 64-89%). The other assessed biomarkers had fair to good performance in mortality prediction with unclear added benefits. Neurofilament light (NfL) (three studies) demonstrated the strongest association in predicting a 6-month poor outcome (GOS-E ≤4; GOS ≤3) (unadjusted pooled AUC 0.81 [95% CI 0.75-0.87]), whereas the other assessed biomarkers had a fair performance with unclear or irrelevant added value. All core biomarkers had only marginal or no association with incomplete recovery and post-concussion symptoms/syndrome, as assessed by RPQ. Serious problems were found in the design and analysis of many of the studies. We conclude that admission measurements of core blood TBI biomarkers, in particular GFAP and UCH-L1, are strongly associated with mortality. There remains little evidence that any of these markers are ready for clinical implementation for prognostic purposes. Future work focused on the intended use and applying unbiased rigorous analysis methods is necessary to demonstrate that the biomarker test results are "prognostically actionable."
循环生物标志物可能会超越当前方法,改善创伤性脑损伤(TBI)患者预后的预测。需要有力且最新的证据来支持其临床应用,并将其纳入医疗实践以指导决策。我们的目的是严格评估六种核心的基于血液的TBI生物标志物(S100钙结合蛋白B、胶质纤维酸性蛋白[GFAP]、神经元特异性烯醇化酶、泛素C末端水解酶-L1[UCH-L1]、tau蛋白和神经丝蛋白)在预测TBI后预后方面的现有证据。检索了包括Medline和Embase在内的电子数据库,查找从建库至2023年10月发表的文章。纳入的研究需评估成年TBI患者入院时血液生物标志物浓度对预后预测的准确性。评估的结局指标为死亡率、格拉斯哥预后量表(GOS)/扩展格拉斯哥预后量表(GOS-E)或里弗米德脑震荡后症状问卷(RPQ)。两名作者独立进行研究选择、数据提取,并使用改良的预后准确性研究质量评估工具进行质量评估,如有分歧通过讨论或仲裁解决。若合适,通过计算加权曲线下面积(AUC)并使用双变量回归模型进行荟萃分析。在检索到的12792条记录中,32篇文章(包括7481例TBI患者)被选为相关文章。两种生物标志物与住院期间及6个月死亡率显示出强关联:GFAP(未调整的合并AUC分别为0.81[95%置信区间[CI]0.75 - 0.87]和0.82[0.80 - 0.85])和UCH-L1(0.80[0.74 - 0.85]和0.83[0.77 - 0.88])。将它们添加到包含既定危险因素的模型中,始终能提高预测价值,不过不同研究中的模型和性能差异很大。在四项同时测量这两种标志物的研究中,当添加到既定预测模型中时,UCH-L1在改善风险分层方面优于GFAP。在约1.5 ng/mL(五项研究)时,GFAP预测死亡率的汇总敏感性为78%(95%CI 67 - 85%),汇总特异性为79%(95%CI 64 - 89%)。其他评估的生物标志物在死亡率预测方面表现一般至良好,但额外益处不明确。神经丝轻链(NfL)(三项研究)在预测6个月不良结局(GOS-E≤4;GOS≤3)方面显示出最强关联(未调整的合并AUC 0.81[95%CI 0.75 - 0.87]),而其他评估的生物标志物表现一般,额外价值不明确或无额外价值。根据RPQ评估,所有核心生物标志物与不完全恢复及脑震荡后症状/综合征仅有微弱关联或无关联。许多研究在设计和分析中存在严重问题。我们得出结论,核心血液TBI生物标志物的入院测量值——尤其是GFAP和UCH-L1——与死亡率密切相关。几乎没有证据表明这些标志物中的任何一种已准备好用于临床预后目的。未来有必要开展聚焦于预期用途并应用无偏严谨分析方法的工作,以证明生物标志物检测结果“在预后方面具有可操作性”。