NEJM：外伤性脑损伤治疗中颅内压监测并无明显作用

颅内压监测被认为是严重外伤性脑损伤的标准护理方式并被广泛应用，但基于监护的治疗对结局的改善还没有得到严格的评估。美国华盛顿大学医学院Chesnut博士等人的研究发现，对于严重外伤性脑损伤患者，使监测颅内压始终保持在20 mm以下的治疗方案与基于成像-临床检查的治疗方案相比，前者并无优越性。他们的论文发表于国际权威杂志NEJM 2012年12月最新一期在线版。

研究人员展开了一项多中心，对照试验，共纳入来自于玻利维亚或厄瓜多尔的324例13岁以上的于特护室(ICUs)接受治疗的严重外伤性脑损伤儿童，随机指定他们其接受以下两项特殊治疗方案中的一项：基于指南的监测实质内颅内压的治疗方案或基于成像和临床检查的治疗方案（成像-临床检查组）。试验主要结局为生存时间、意识损害、以及3个月或6个月的功能状态以及6个月时的神经心理学状态。神经心理学状态由不清楚方案设定的检查者予以评估。这一复合标准是由基于21项功能和认知障碍持续状态的测量以及计算所得出的百分位数表示（0表示最差的状态，100表示最优的状态）。

结果显示，试验主要终点、基于21项功能和认知障碍持续状态的百分数指标（得分，压力监测组56 VS 成像临床检查组53；P=0.49）无显著性的组间差异。研究人员发现，6个月时压力监测组的死亡率为39%，而成像-临床检查组为41% (P=0.60)。两组中位ICU住院时间相似（压力监测组为12天，成像-临床检查组为9天；P=0.25），然而，成像-临床检查组与压力监测组相比，前者ICU脑特异性治疗（如高渗性泻药以及换气过度的应用）的天数更多(4.8 vs. 3.4, P=0.002)。两组间严重不良反应事件分布相似。

研究人员由此得出结论，对于严重外伤性脑损伤患者，使监测颅内压始终保持在20 mm以下的治疗方案与基于成像-临床检查的治疗方案相比，前者并无优越性。

DOI: 10.1056/NEJMoa1207363
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A Trial of Intracranial-Pressure Monitoring in Traumatic Brain Injury

Randall M. Chesnut, M.D., Nancy Temkin, Ph.D., Nancy Carney, Ph.D., Sureyya Dikmen, Ph.D., Carlos Rondina, M.D., Walter Videtta, M.D., Gustavo Petroni, M.D., Silvia Lujan, M.D., Jim Pridgeon, M.H.A., Jason Barber, M.S., Joan Machamer, M.A., Kelley Chaddock, B.A., Juanita M. Celix, M.D., Marianna Cherner, Ph.D., and Terence Hendrix, B.A.

BACKGROUND Intracranial-pressure monitoring is considered the standard of care for severe traumatic brain injury and is used frequently, but the efficacy of treatment based on monitoring in improving the outcome has not been rigorously assessed. METHODS We conducted a multicenter, controlled trial in which 324 patients 13 years of age or older who had severe traumatic brain injury and were being treated in intensive care units (ICUs) in Bolivia or Ecuador were randomly assigned to one of two specific protocols: guidelines-based management in which a protocol for monitoring intraparenchymal intracranial pressure was used (pressure-monitoring group) or a protocol in which treatment was based on imaging and clinical examination (imaging–clinical examination group). The primary outcome was a composite of survival time, impaired consciousness, and functional status at 3 months and 6 months and neuropsychological status at 6 months; neuropsychological status was assessed by an examiner who was unaware of protocol assignment. This composite measure was based on performance across 21 measures of functional and cognitive status and calculated as a percentile (with 0 indicating the worst performance, and 100 the best performance). RESULTS There was no significant between-group difference in the primary outcome, a composite measure based on percentile performance across 21 measures of functional and cognitive status (score, 56 in the pressure-monitoring group vs. 53 in the imaging–clinical examination group; P=0.49). Six-month mortality was 39% in the pressure-monitoring group and 41% in the imaging–clinical examination group (P=0.60). The median length of stay in the ICU was similar in the two groups (12 days in the pressure-monitoring group and 9 days in the imaging–clinical examination group; P=0.25), although the number of days of brain-specific treatments (e.g., administration of hyperosmolar fluids and the use of hyperventilation) in the ICU was higher in the imaging–clinical examination group than in the pressure-monitoring group (4.8 vs. 3.4, P=0.002). The distribution of serious adverse events was similar in the two groups. CONCLUSIONS For patients with severe traumatic brain injury, care focused on maintaining monitored intracranial pressure at 20 mm Hg or less was not shown to be superior to care based on imaging and clinical examination. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT01068522.)