Surgical decompression for space-occupying cerebral infarction (the Hemicraniectomy After Middle Cerebral Artery infarction with Life-threatening Edema Trial [HAMLET]): a multicentre, open, randomised trial
Surgical decompression for space-occupying cerebral infarction (the Hemicraniectomy After Middle Cerebral Artery infarction with Life-threatening Edema Trial [HAMLET]): a multicentre, open, randomised trial
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DOI：
10.1016/s1474-4422(09)70047-x
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发表时间：
2009-04-01
期刊：
影响因子：
48
通讯作者：
van der Worp, H. Bart
中科院分区：
文献类型：
--
作者：
Hofmeijer, Jeannette;Kappelle, L. Jaap;van der Worp, H. Bart
背景：脑半球占位性梗死患者预后差，病死率高达80%。在一项随机试验的汇总分析中，卒中发作48小时内的手术减压降低了病死率，改善了功能结局;然而，更长时间间隔后的手术效果尚不清楚。哈姆雷特的目的是评估4天内的症状发作的患者占位性半球infarction.Methods患者占位性半球infarction的减压手术的效果随机分配在4天内中风发作的手术减压或最佳的药物治疗。主要结局指标为1年时的改良兰金量表（mRS）评分，分为良好（0-3）和不良（4-6）结局。其他结局指标包括mRS评分在4和5之间的二分法、病死率、生活质量和抑郁症状。研究结果：2002年11月至2007年10月，64例患者被纳入，32例被随机分配到手术减压组，32例被随机分配到最佳药物治疗组。手术减压对主要结局指标无影响（绝对风险降低[ARR] 0%，95%CI-21至21），但确实降低了病死率（ARR 38%，15至60）。在DECIMAL患者的荟萃分析中，（恶性大脑中动脉梗死的减压开颅术），DESTINY（减压手术治疗大脑中动脉恶性梗死）和哈姆雷特患者在卒中发作48小时内随机分组，手术减压减少了不良结局（ARR 16%，-0.1至33）和病死率（ARR 50%，34至66）。解释手术减压减少了在卒中发作48小时内治疗的占位性梗死患者的病死率和不良结局。没有证据表明，这种手术改善功能的结果时，它被推迟到96小时后中风发作。决定进行手术应取决于强调病人和亲属属性的生存和依赖。
Background Patients with space-occupying hemispheric infarctions have a poor prognosis, with case fatality rates of up to 80%. In a pooled analysis of randomised trials, surgical decompression within 48 h of stroke onset reduced case fatality and improved functional outcome; however, the effect of surgery after longer intervals is unknown. The aim of HAMLET was to assess the effect of decompressive surgery within 4 days of the onset of symptoms in patients with space-occupying hemispheric infarction.Methods Patients with space-occupying hemispheric infarction were randomly assigned within 4 days of stroke onset to surgical decompression or best medical treatment. The primary outcome measure was the modified Rankin scale (mRS) score at 1 year, which was dichotomised between good (0-3) and poor (4-6) outcome. Other outcome measures were the dichotomy of mRS score between 4 and 5, case fatality, quality of life, and symptoms of depression. Analysis was by intention to treat. This trial is registered, ISRCTN94237756.Findings Between November, 2002, and October, 2007, 64 patients were included; 32 were randomly assigned to surgical decompression and 32 to best medical treatment. Surgical decompression had no effect on the primary outcome measure (absolute risk reduction [ARR] 0%, 95% CI -21 to 21) but did reduce case fatality (ARR 38%, 15 to 60). In a meta-analysis of patients in DECIMAL (DEcompressive Craniectomy In MALignant middle cerebral artery infarction), DESTINY (DEcompressive Surgery for the Treatment of malignant INfarction of the middle cerebral arterY), and HAMLET who were randomised within 48 h of stroke onset, surgical decompression reduced poor outcome (ARR 16%, -0.1 to 33) and case fatality (ARR 50%, 34 to 66).Interpretation Surgical decompression reduces case fatality and poor outcome in patients with space-occupying infarctions who are treated within 48 h of stroke onset. There is no evidence that this operation improves functional outcome when it is delayed for up to 96 h after stroke onset. The decision to perform the operation should depend on the emphasis patients and relatives attribute to survival and dependency.