Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials
Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials
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DOI：
10.1016/s1474-4422(07)70036-4
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发表时间：
2007-03-01
期刊：
影响因子：
48
通讯作者：
Hacke, Werner
中科院分区：
文献类型：
--
作者：
Vahedi, Katayoun;Hofmeijer, Jeannette;Hacke, Werner
背景大脑中动脉恶性梗塞(MCA)与80%的死亡率有关。非随机研究表明，减压手术在不增加严重残疾幸存者数量的情况下降低了死亡率。为了尽快获得足够的数据以可靠地估计减压手术的效果，来自三个欧洲随机对照试验(DECIMAL、DISTIFY、HAMLET)的结果被合并在一起。这些试验在计划合并分析时仍在进行中。方法将年龄在18岁至60岁之间、大脑中动脉占位性脑梗塞、纳入三项试验之一并在卒中发病后48小时内接受治疗的患者的个体数据进行合并分析。该方案是在试验仍在招募患者时前瞻性设计的，结果是在不知道个别试验结果的情况下确定的。主要的结果衡量标准是1年后改良Rankin量表(MRS)的评分，分为好的(0-4)和不好的(5和死亡)。次要结果测量包括1年病死率和0-3至4岁至死亡的MRS的二分性。数据分析由一个独立的数据监测委员会完成。结果93名患者被纳入合并分析。减压手术组的MRS患者比对照组多
Background Malignant infarction of the middle cerebral artery (MCA) is associated with an 80% mortality rate. Non-randomised studies have suggested that decompressive surgery reduces this mortality without increasing the number of severely disabled survivors. To obtain sufficient data as soon as possible to reliably estimate the effects of decompressive surgery, results from three European randomised controlled trials (DECIMAL, DESTINY, HAMLET) were pooled. The trials were ongoing when the pooled analysis was planned.Methods Individual data for patients aged between 18 years and 60 years, with space-occupying MCA infarction, included in one of the three trials, and treated within 48 h after stroke onset were pooled for analysis. The protocol was designed prospectively when the trials were still recruiting patients and outcomes were defined without knowledge of the results of the individual trials. The primary outcome measure was the score on the modified Rankin scale (mRS) at 1 year dichotomised between favourable (0-4) and unfavourable (5 and death) outcome. Secondary outcome measures included case fatality rate at 1 year and a dichotomisation of the mRS between 0-3 and 4 to death. Data analysis was done by an independent data monitoring committee.Findings 93 patients were included in the pooled analysis. More patients in the decompressive-surgery group than in the control group had an mRS