创伤性颅内高压减压性颅骨切除术试验

Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension.

作者信息

Hutchinson Peter J, Kolias Angelos G, Timofeev Ivan S, Corteen Elizabeth A, Czosnyka Marek, Timothy Jake, Anderson Ian, Bulters Diederik O, Belli Antonio, Eynon C Andrew, Wadley John, Mendelow A David, Mitchell Patrick M, Wilson Mark H, Critchley Giles, Sahuquillo Juan, Unterberg Andreas, Servadei Franco, Teasdale Graham M, Pickard John D, Menon David K, Murray Gordon D, Kirkpatrick Peter J

机构信息

From the Division of Neurosurgery, Department of Clinical Neurosciences (P.J.H., A.G.K., I.S.T., E.A.C., M.C., J.D.P., P.J.K.), and the Division of Anaesthesia (D.K.M.), Addenbrooke's Hospital and University of Cambridge, Cambridge, the Department of Neurosurgery, Leeds General Infirmary, Leeds (J.T., I.A.), the Department of Neurosurgery (D.O.B.) and Neurosciences Intensive Care Unit (C.A.E.), Wessex Neurological Centre, University Hospital Southampton, Southampton, the NIHR Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham (A.B.), the Department of Neurosurgery, St. Bartholomew's and Royal London Hospital (J.W.), and the Department of Neurosurgery, St. Mary's Hospital (M.H.W.), London, the Institute of Neuroscience, Neurosurgical Trials Group, Newcastle University (A.D.M.), and the Department of Neurosurgery, Royal Victoria Infirmary (P.M.M.), Newcastle upon Tyne, Hurstwood Park Neurosciences Centre, Brighton and Sussex University Hospitals, Haywards Heath (G.C.), the Institute of Health and Wellbeing, University of Glasgow, Glasgow (G.M.T.), and Usher Institute of Population Health Sciences and Informatics, University of Edinburgh Medical School, University of Edinburgh, Edinburgh (G.D.M.) - all in the United Kingdom; the Department of Neurosurgery, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona (J.S.); the Department of Neurosurgery, University of Heidelberg, Heidelberg, Germany (A.U.); and the Neurosurgery-Neurotraumatology Unit, Azienda Ospedaliero-Universitaria di Parma, Arcispedale S. Maria Nuova-IRCCS Reggio Emilia, University of Parma, Parma, Italy (F.S.).

出版信息

N Engl J Med. 2016 Sep 22;375(12):1119-30. doi: 10.1056/NEJMoa1605215. Epub 2016 Sep 7.

DOI:10.1056/NEJMoa1605215

PMID:27602507

Abstract

BACKGROUND

The effect of decompressive craniectomy on clinical outcomes in patients with refractory traumatic intracranial hypertension remains unclear.

METHODS

From 2004 through 2014, we randomly assigned 408 patients, 10 to 65 years of age, with traumatic brain injury and refractory elevated intracranial pressure (>25 mm Hg) to undergo decompressive craniectomy or receive ongoing medical care. The primary outcome was the rating on the Extended Glasgow Outcome Scale (GOS-E) (an 8-point scale, ranging from death to "upper good recovery" [no injury-related problems]) at 6 months. The primary-outcome measure was analyzed with an ordinal method based on the proportional-odds model. If the model was rejected, that would indicate a significant difference in the GOS-E distribution, and results would be reported descriptively.

RESULTS

The GOS-E distribution differed between the two groups (P<0.001). The proportional-odds assumption was rejected, and therefore results are reported descriptively. At 6 months, the GOS-E distributions were as follows: death, 26.9% among 201 patients in the surgical group versus 48.9% among 188 patients in the medical group; vegetative state, 8.5% versus 2.1%; lower severe disability (dependent on others for care), 21.9% versus 14.4%; upper severe disability (independent at home), 15.4% versus 8.0%; moderate disability, 23.4% versus 19.7%; and good recovery, 4.0% versus 6.9%. At 12 months, the GOS-E distributions were as follows: death, 30.4% among 194 surgical patients versus 52.0% among 179 medical patients; vegetative state, 6.2% versus 1.7%; lower severe disability, 18.0% versus 14.0%; upper severe disability, 13.4% versus 3.9%; moderate disability, 22.2% versus 20.1%; and good recovery, 9.8% versus 8.4%. Surgical patients had fewer hours than medical patients with intracranial pressure above 25 mm Hg after randomization (median, 5.0 vs. 17.0 hours; P<0.001) but had a higher rate of adverse events (16.3% vs. 9.2%, P=0.03).

CONCLUSIONS

At 6 months, decompressive craniectomy in patients with traumatic brain injury and refractory intracranial hypertension resulted in lower mortality and higher rates of vegetative state, lower severe disability, and upper severe disability than medical care. The rates of moderate disability and good recovery were similar in the two groups. (Funded by the Medical Research Council and others; RESCUEicp Current Controlled Trials number, ISRCTN66202560 .).

摘要

背景

减压性颅骨切除术对难治性创伤性颅内高压患者临床结局的影响尚不清楚。

方法

2004年至2014年，我们将408例年龄在10至65岁、患有创伤性脑损伤且颅内压难治性升高（>25 mmHg）的患者随机分为两组，一组接受减压性颅骨切除术，另一组接受持续药物治疗。主要结局是6个月时的扩展格拉斯哥预后量表（GOS-E）评分（8分制，范围从死亡到“良好恢复”[无损伤相关问题]）。主要结局指标采用基于比例优势模型的序贯方法进行分析。如果该模型被拒绝，则表明GOS-E分布存在显著差异，结果将进行描述性报告。

结果

两组的GOS-E分布存在差异（P<0.001）。比例优势假设被拒绝，因此结果进行描述性报告。6个月时，GOS-E分布如下：死亡，手术组201例患者中占26.9%，药物治疗组188例患者中占48.9%；植物状态，分别为8.5%和2.1%；重度残疾（依赖他人照顾），分别为21.9%和14.4%；中度残疾（在家中独立），分别为15.4%和8.0%；中度残疾，分别为23.4%和19.7%；良好恢复，分别为4.0%和6.9%。12个月时，GOS-E分布如下：死亡，手术组194例患者中占30.4%，药物治疗组179例患者中占52.0%；植物状态，分别为6.2%和1.7%；重度残疾，分别为18.0%和14.0%；中度残疾，分别为13.4%和3.9%；中度残疾，分别为22.2%和20.1%；良好恢复，分别为9.8%和8.4%。随机分组后，手术患者颅内压高于25 mmHg的小时数少于药物治疗患者（中位数，5.0小时对17.0小时；P<0.001），但不良事件发生率较高（16.3%对9.2%，P=0.03）。