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离散性脑低温治疗创伤性脑损伤:一项随机对照试验。

Discrete cerebral hypothermia in the management of traumatic brain injury: a randomized controlled trial.

作者信息

Harris Odette A, Muh Carrie R, Surles Monique C, Pan Yi, Rozycki Grace, Macleod Jana, Easley Kirk

机构信息

Departments of Neurosurgery, Emory University School of Medicine, Atlanta, Georgia, USA.

出版信息

J Neurosurg. 2009 Jun;110(6):1256-64. doi: 10.3171/2009.1.JNS081320.

Abstract

OBJECT

Hypothermia has been extensively evaluated in the management of traumatic brain injury (TBI), but no consensus as to its effectiveness has yet been reached. Explanatory hypotheses include a possible confounding effect of the neuroprotective benefits by adverse systemic effects. To minimize the systemic effects, the authors evaluated a selective cerebral cooling system, the CoolSystem Discrete Cerebral Hypothermia System (a "cooling cap"), in the management of TBI.

METHODS

A prospective randomized controlled clinical trial was conducted at Grady Memorial Hospital, a Level I trauma center. Adults admitted with severe TBI (Glasgow Coma Scale [GCS] score < or = 8) were eligible. Patients assigned to the treatment group received the cooling cap, while those in the control group did not. Patients in the treatment group were treated with selective cerebral hypothermia for 24 hours, then rewarmed over 24 hours. Their intracranial and bladder temperatures, cranial-bladder temperature gradient, Glasgow Outcome Scale (GOS) and Functional Independence Measure (FIM) scores, and mortality rates were evaluated. The primary outcome was to establish a cranial-bladder temperature gradient in those patients with the cooling cap. The secondary outcomes were mortality and morbidity per GOS and FIM scores.

RESULTS

The cohort comprised 25 patients (12 in the treatment group, 13 controls). There was no significant intergroup difference in demographic data or median GCS score at enrollment (treatment group 3.0, controls 3.0; p = 0.7). After the third hour of the study, the mean intracranial temperature of the treatment group was significantly lower than that of the controls at all time points except Hours 4 (p = 0.08) and 6 (p = 0.08). However, the target intracranial temperature of 33 degrees C was achieved in only 2 patients in the treatment group. The mean intracranial-bladder temperature gradient was not significant for the treatment group (p = 0.07) or the controls (p = 0.67). Six (50.0%) of 12 patients in the treatment group and 4 (30.8%) of 13 in the control group died (p = 0.43). The medians of the maximum change in GOS and FIM scores during the study period (28 days) for both groups were 0. There was no significant difference in complications between the groups (p value range 0.20-1.0).

CONCLUSIONS

The cooling cap was not effective in establishing a statistically significant cranial-bladder temperature gradient or in reaching the target intracranial temperature in the majority of patients. No significant difference was achieved in mortality or morbidity between the 2 groups. As the technology currently stands, the Discrete Cerebral Hypothermia System cooling cap is not beneficial for the management of TBI. Further refinement of the equipment available for the delivery of selective cranial cooling will be needed before any definite conclusions regarding the efficacy of discrete cerebral hypothermia can be reached.

摘要

目的

低温疗法已在创伤性脑损伤(TBI)的治疗中得到广泛评估,但对于其有效性尚未达成共识。解释性假说包括神经保护益处可能受到不良全身效应的混杂影响。为了尽量减少全身效应,作者评估了一种选择性脑冷却系统,即CoolSystem离散脑低温系统(一种“冷却帽”)在TBI治疗中的作用。

方法

在一级创伤中心格雷迪纪念医院进行了一项前瞻性随机对照临床试验。收治的重度TBI成人患者(格拉斯哥昏迷量表[GCS]评分≤8分)符合条件。分配到治疗组的患者佩戴冷却帽,而对照组患者不佩戴。治疗组患者接受选择性脑低温治疗24小时,然后在24小时内复温。评估他们的颅内和膀胱温度、颅-膀胱温度梯度、格拉斯哥预后量表(GOS)和功能独立性测量(FIM)评分以及死亡率。主要结局是确定佩戴冷却帽患者的颅-膀胱温度梯度。次要结局是根据GOS和FIM评分得出的死亡率和发病率。

结果

该队列包括25例患者(治疗组12例,对照组13例)。入组时,两组在人口统计学数据或GCS评分中位数方面无显著组间差异(治疗组3.0分,对照组3.0分;p = 0.7)。研究开始后第3小时,除第4小时(p = 0.08)和第6小时(p = 0.08)外,治疗组的平均颅内温度在所有时间点均显著低于对照组。然而,治疗组中只有2例患者达到了33℃的目标颅内温度。治疗组(p = 0.07)和对照组(p = 0.67)的平均颅-膀胱温度梯度均无统计学意义。治疗组12例患者中有6例(50.0%)死亡,对照组13例患者中有4例(30.8%)死亡(p = 0.43)。两组在研究期间(28天)GOS和FIM评分的最大变化中位数均为0。两组之间的并发症无显著差异(p值范围为0.20 - 1.0)。

结论

冷却帽在大多数患者中未能有效建立具有统计学意义的颅-膀胱温度梯度或达到目标颅内温度。两组在死亡率或发病率方面未取得显著差异。就目前的技术水平而言,离散脑低温系统冷却帽对TBI的治疗并无益处。在就离散脑低温疗法的疗效得出任何明确结论之前,需要进一步改进用于选择性颅脑冷却的设备。

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