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Abstract：
BACKGROUND: Traumatic brain injury (TBI) is one of the most common causes of death and an important burden to the worldwide healthcare system and society. There is a lack of guidelines for types of monitoring or neuroprotective therapy. The aim of this pilot study was to assess its feasibility and, furthermore, to evaluate the impact of Cerebrolysin on the following clinical outcomes: length of stay, Glasgow Outcome Scale (GOS) and mortality.
METHODS: A cohort of 56 patients was included in this non-randomised, real-time, pre-post-interventional study. The patients were assessed with the Glasgow Coma Scale (GCS) and divided into two groups: severe (GCS < 8) and non-severe (GCS > 8). After the radiological examination (CT scan), the patients were qualified for an immediate neurosurgical procedure if needed. The patients were admitted to the intensive care unit, where a standardised protocol for TBI treatment was implemented. Additional neuromonitoring was applied.
RESULTS: There were 56 patients (19 females; 33.9%), of which 41 were considered severe cases; the patients were allocated to the Cerebrolysin (n = 25) or control groups (n = 31). In a generalised linear model (GLM) approach, the use of Cerebrolysin was associated with a decrease in the probability of death in non-severe patients (by 0.333 (standard error (SE) = 0.157, p = 0.034)) but not in severe patients (estimate (Est.) = -0.115, SE = 0.127, p = 0.364). Patients who received Cerebrolysin and who were neuromonitored had favourable outcomes and better survival rates.
CONCLUSIONS: A multimodal treatment approach with monitoring and Cerebrolysin may have a beneficial effect on patients with less severe TBIs; however, the present study has multiple limitations, and further research is needed.
METHODS: A cohort of 56 patients was included in this non-randomised, real-time, pre-post-interventional study. The patients were assessed with the Glasgow Coma Scale (GCS) and divided into two groups: severe (GCS < 8) and non-severe (GCS > 8). After the radiological examination (CT scan), the patients were qualified for an immediate neurosurgical procedure if needed. The patients were admitted to the intensive care unit, where a standardised protocol for TBI treatment was implemented. Additional neuromonitoring was applied.
RESULTS: There were 56 patients (19 females; 33.9%), of which 41 were considered severe cases; the patients were allocated to the Cerebrolysin (n = 25) or control groups (n = 31). In a generalised linear model (GLM) approach, the use of Cerebrolysin was associated with a decrease in the probability of death in non-severe patients (by 0.333 (standard error (SE) = 0.157, p = 0.034)) but not in severe patients (estimate (Est.) = -0.115, SE = 0.127, p = 0.364). Patients who received Cerebrolysin and who were neuromonitored had favourable outcomes and better survival rates.
CONCLUSIONS: A multimodal treatment approach with monitoring and Cerebrolysin may have a beneficial effect on patients with less severe TBIs; however, the present study has multiple limitations, and further research is needed.
摘要：
背景：创伤性脑损伤（TBI）是最常见的死亡原因之一，是全球医疗保健系统和社会的重要负担。缺乏监测或神经保护治疗类型的指南。这项试点研究的目的是评估其可行性，此外，评估脑活素对以下临床结局的影响：住院时间，格拉斯哥预后量表（GOS）和死亡率。
方法：本研究纳入了56名患者的非随机队列，实时,介入研究前。采用格拉斯哥昏迷量表（GCS）对患者进行评估，并分为两组：重度（GCS<8）和非重度（GCS>8）。放射学检查（CT扫描）后，如果需要，患者有资格立即进行神经外科手术。病人被送进了重症监护室,实施了标准化的TBI治疗方案。应用额外的神经监测。
结果：有56例患者（19例女性；33.9%），其中41例被认为是严重病例;患者被分配到脑活素组(n=25)或对照组(n=31)。在广义线性模型(GLM)方法中，脑活素的使用与非重度患者的死亡概率降低相关(降低0.333(标准误差(SE)=0.157,p=0.034)),但与重度患者的死亡概率无关(估计(Est.)=-0.115，SE=0.127，p=0.364）。接受脑活素和神经监测的患者具有良好的预后和更好的生存率。
结论：监测和脑活素的多模式治疗方法可能对TBI严重程度较低的患者有有益效果；然而，本研究有多重局限性，需要进一步的研究。
方法：本研究纳入了56名患者的非随机队列，实时,介入研究前。采用格拉斯哥昏迷量表（GCS）对患者进行评估，并分为两组：重度（GCS<8）和非重度（GCS>8）。放射学检查（CT扫描）后，如果需要，患者有资格立即进行神经外科手术。病人被送进了重症监护室,实施了标准化的TBI治疗方案。应用额外的神经监测。
结果：有56例患者（19例女性；33.9%），其中41例被认为是严重病例;患者被分配到脑活素组(n=25)或对照组(n=31)。在广义线性模型(GLM)方法中，脑活素的使用与非重度患者的死亡概率降低相关(降低0.333(标准误差(SE)=0.157,p=0.034)),但与重度患者的死亡概率无关(估计(Est.)=-0.115，SE=0.127，p=0.364）。接受脑活素和神经监测的患者具有良好的预后和更好的生存率。
结论：监测和脑活素的多模式治疗方法可能对TBI严重程度较低的患者有有益效果；然而，本研究有多重局限性，需要进一步的研究。
