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院前血清 S100B 和 GFAP 对轻度创伤性脑损伤患者的诊断准确性:一项前瞻性观察性多中心队列研究——“PreTBI I 研究”。

Diagnostic accuracy of prehospital serum S100B and GFAP in patients with mild traumatic brain injury: a prospective observational multicenter cohort study - "the PreTBI I study".

机构信息

Research and Development, Prehospital Emergency Medical Services, Central Denmark Region, Olof Palmes Allé 34 2, Aarhus, Denmark.

Department of Clinical Medicine, Aarhus University, Incuba Skejby, bld. 2, Palle Juul-Jensens Blvd 82, Aarhus, Denmark.

出版信息

Scand J Trauma Resusc Emerg Med. 2021 Jun 2;29(1):75. doi: 10.1186/s13049-021-00891-5.

Abstract

BACKGROUND

The biomarker serum S100 calcium-binding protein B (S100B) is used in in-hospital triage of adults with mild traumatic brain injury to rule out intracranial lesions. The biomarker glial fibrillary acidic protein (GFAP) is suggested as a potential diagnostic biomarker for traumatic brain injury. The aim of this study was to investigate the diagnostic accuracy of early prehospital S100B and GFAP measurements to rule out intracranial lesions in adult patients with mild traumatic brain injury.

METHODS

Prehospital and in-hospital blood samples were drawn from 566 adult patients with mild traumatic brain injury (Glasgow Coma Scale Score 14-15). The index test was S100B and GFAP concentrations. The reference standard was endpoint adjudication of the traumatic intracranial lesion based on medical records. The primary outcome was prehospital sensitivity of S100B in relation to the traumatic intracranial lesion.

RESULTS

Traumatic intracranial lesions were found in 32/566 (5.6%) patients. The sensitivity of S100B > 0.10 μg/L was 100% (95%CI: 89.1;100.0) in prehospital samples and 100% (95% CI 89.1;100.0) in in-hospital samples. The specificity was 15.4% (95%CI: 12.4;18.7) in prehospital samples and 31.5% (27.5;35.6) in in-hospital samples. GFAP was only detected in less than 2% of cases with the assay used.

CONCLUSION

Early prehospital and in-hospital S100B levels < 0.10 μg/L safely rules out traumatic intracranial lesions in adult patients with mild traumatic brain injury, but specificity is lower with early prehospital sampling than with in-hospital sampling. The very limited cases with values detectable with our assay do not allow conclusions to be draw regarding the diagnostic accuracy of GFAP.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT02867137 .

摘要

背景

血清 S100 钙结合蛋白 B(S100B)是一种生物标志物,用于在院内对轻度创伤性脑损伤的成年人进行分诊,以排除颅内病变。神经胶质纤维酸性蛋白(GFAP)被认为是创伤性脑损伤的潜在诊断生物标志物。本研究旨在探讨早期院前 S100B 和 GFAP 测量值排除成人轻度创伤性脑损伤患者颅内病变的诊断准确性。

方法

对 566 例格拉斯哥昏迷量表评分 14-15 分的成年轻度创伤性脑损伤患者进行院前和院内采血。以 S100B 和 GFAP 浓度作为检测指标,以基于病历的创伤性颅内病变终点裁决作为参考标准。主要结局为院前 S100B 与创伤性颅内病变的敏感性。

结果

566 例患者中,32 例(5.6%)发现创伤性颅内病变。在院前样本中,S100B>0.10μg/L 的敏感性为 100%(95%CI:89.1%;100.0%),在院内样本中为 100%(95%CI 89.1%;100.0%)。在院前样本中,特异性为 15.4%(95%CI:12.4%;18.7%),在院内样本中为 31.5%(27.5%;35.6%)。使用该检测方法,GFAP 仅在不到 2%的病例中被检测到。

结论

早期院前和院内 S100B 水平<0.10μg/L 可安全排除成年轻度创伤性脑损伤患者的创伤性颅内病变,但早期院前采样的特异性低于院内采样。用我们的检测方法检测到的有限数量的病例,无法得出关于 GFAP 诊断准确性的结论。

试验注册

ClinicalTrials.gov 标识符:NCT02867137。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f162/8173808/35e473e537ab/13049_2021_891_Fig1_HTML.jpg

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