Hofmeijer Jeannette, Amelink G Johan, Algra Ale, van Gijn Jan, Macleod Malcolm R, Kappelle L Jaap, van der Worp H Bart
Department of Neurology, University Medical Centre Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.
Trials. 2006 Sep 11;7:29. doi: 10.1186/1745-6215-7-29.
Patients with a hemispheric infarct and massive space-occupying brain oedema have a poor prognosis. Despite maximal conservative treatment, the case fatality rate may be as high as 80%, and most survivors are left severely disabled. Non-randomised studies suggest that decompressive surgery reduces mortality substantially and improves functional outcome of survivors. This study is designed to compare the efficacy of decompressive surgery to improve functional outcome with that of conservative treatment in patients with space-occupying supratentorial infarction
The study design is that of a multi-centre, randomised clinical trial, which will include 112 patients aged between 18 and 60 years with a large hemispheric infarct with space-occupying oedema that leads to a decrease in consciousness. Patients will be randomised to receive either decompressive surgery in combination with medical treatment or best medical treatment alone. Randomisation will be stratified for the intended mode of conservative treatment (intensive care or stroke unit care). The primary outcome measure will be functional outcome, as determined by the score on the modified Rankin Scale, at one year.
患有半球梗死和大面积占位性脑水肿的患者预后较差。尽管采取了最大程度的保守治疗，病死率仍可能高达80%，且大多数幸存者会严重致残。非随机研究表明，减压手术可大幅降低死亡率并改善幸存者的功能结局。本研究旨在比较减压手术与保守治疗对幕上占位性梗死患者功能结局改善的疗效。
本研究设计为多中心随机临床试验，将纳入112例年龄在18至60岁之间、患有大面积半球梗死伴占位性水肿导致意识下降的患者。患者将被随机分配接受减压手术联合药物治疗或单纯最佳药物治疗。随机分组将根据预期的保守治疗模式（重症监护或卒中单元护理）进行分层。主要结局指标将是一年时由改良Rankin量表评分确定的功能结局。
