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戊巴比妥与硫喷妥钠治疗创伤性脑损伤患者难治性颅内高压的随机对照试验

Pentobarbital versus thiopental in the treatment of refractory intracranial hypertension in patients with traumatic brain injury: a randomized controlled trial.

作者信息

Pérez-Bárcena Jon, Llompart-Pou Juan A, Homar Javier, Abadal Josep M, Raurich Joan M, Frontera Guillem, Brell Marta, Ibáñez Javier, Ibáñez Jordi

机构信息

Intensive Care Medicine Department, Son Dureta University Hospital, Andrea Doria 55, Palma de Mallorca, 07014, Spain.

出版信息

Crit Care. 2008;12(4):R112. doi: 10.1186/cc6999. Epub 2008 Aug 29.

Abstract

INTRODUCTION

Experimental research has demonstrated that the level of neuroprotection conferred by the various barbiturates is not equal. Until now no controlled studies have been conducted to compare their effectiveness, even though the Brain Trauma Foundation Guidelines recommend that such studies be undertaken. The objectives of the present study were to assess the effectiveness of pentobarbital and thiopental in terms of controlling refractory intracranial hypertension in patients with severe traumatic brain injury, and to evaluate the adverse effects of treatment.

METHODS

This was a prospective, randomized, cohort study comparing two treatments: pentobarbital and thiopental. Patients who had suffered a severe traumatic brain injury (Glasgow Coma Scale score after resuscitation < or = 8 points or neurological deterioration during the first week after trauma) and with refractory intracranial hypertension (intracranial pressure > 20 mmHg) first-tier measures, in accordance with the Brain Trauma Foundation Guidelines.

RESULTS

A total of 44 patients (22 in each group) were included over a 5-year period. There were no statistically significant differences in ' baseline characteristics, except for admission computed cranial tomography characteristics, using the Traumatic Coma Data Bank classification. Uncontrollable intracranial pressure occurred in 11 patients (50%) in the thiopental treatment group and in 18 patients (82%) in the pentobarbital group (P = 0.03). Under logistic regression analysis--undertaken in an effort to adjust for the cranial tomography characteristics, which were unfavourable for pentobarbital--thiopental was more effective than pentobarbital in terms of controlling intracranial pressure (odds ratio = 5.1, 95% confidence interval 1.2 to 21.9; P = 0.027). There were no significant differences between the two groups with respect to the incidence of arterial hypotension or infection.

CONCLUSIONS

Thiopental appeared to be more effective than pentobarbital in controlling intracranial hypertension refractory to first-tier measures. These findings should be interpreted with caution because of the imbalance in cranial tomography characteristics and the different dosages employed in the two arms of the study. The incidence of adverse effects was similar in both groups.

TRIAL REGISTRATION

(Trial registration: US Clinical Trials registry NCT00622570.).

摘要

引言

实验研究表明,各种巴比妥类药物所提供的神经保护水平并不相同。尽管脑创伤基金会指南建议开展此类研究,但迄今为止尚未进行对照研究来比较它们的有效性。本研究的目的是评估戊巴比妥和硫喷妥钠在控制重型颅脑损伤患者难治性颅内高压方面的有效性,并评估治疗的不良反应。

方法

这是一项前瞻性、随机、队列研究,比较两种治疗方法:戊巴比妥和硫喷妥钠。根据脑创伤基金会指南,纳入遭受重型颅脑损伤(复苏后格拉斯哥昏迷量表评分≤8分或创伤后第一周内神经功能恶化)且伴有难治性颅内高压(颅内压>20 mmHg)的患者作为一线治疗对象。

结果

在5年期间共纳入44例患者(每组22例)。除了使用创伤昏迷数据库分类的入院计算机断层扫描特征外,两组患者的基线特征无统计学显著差异。硫喷妥钠治疗组有11例患者(50%)出现无法控制的颅内压,戊巴比妥组有18例患者(82%)出现无法控制的颅内压(P = 0.03)。在进行逻辑回归分析以调整对戊巴比妥不利的颅脑断层扫描特征后,硫喷妥钠在控制颅内压方面比戊巴比妥更有效(优势比=5.1,95%置信区间1.2至21.9;P = 0.027)。两组在动脉低血压或感染发生率方面无显著差异。

结论

硫喷妥钠在控制一线治疗难治性颅内高压方面似乎比戊巴比妥更有效。由于颅脑断层扫描特征的不平衡以及研究两组中使用的不同剂量,这些发现应谨慎解释。两组不良反应的发生率相似。

试验注册

(试验注册:美国临床试验注册中心NCT00622570。)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df94/2575601/94d74dd993bb/cc6999-1.jpg

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