本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2308440

摘要内容如下：

背景

手术清除幕上脑出血的试验通常没有显示出功能上的益处。早期微创手术切除是否比药物治疗效果更好尚不清楚。

方法

在这项涉及急性脑出血患者的多中心随机试验中，我们评估了手术清除血肿与药物治疗的比较。脑叶或前基底节区出血且血肿量为30至80 mL的患者，在最后一次被确认为健康后的24小时内，以1:1的比例被分配接受微创手术清除血肿加基于指南的药物治疗（手术组）或仅接受基于指南的药物治疗（对照组）。主要疗效终点是180天时效用加权改良Rankin量表的平均得分（范围为0至1，根据患者的评估，得分越高表明预后越好），预先指定的优势后验概率阈值为0.975或更高。该试验包括根据出血部位调整入选标准的规则。主要安全性终点为入组后30天内死亡。

结果

共纳入300例患者，其中30.7%为前基底节区出血，69.3%为脑叶出血。175名患者入组后，触发适应规则，仅有脑叶出血患者入组。在180天时，手术组的效用加权改良Rankin量表的平均得分为0.458，对照组为0.374（差异为0.08 4；95%贝叶斯可信区间，0.00 5~0.163；手术优势的后验概率为0.981）。脑叶出血患者的平均组间差异为0.127（95%贝叶斯可信区间，0.03 5至0.219），基底节前部出血患者的平均组间差异为-0.013（95%贝叶斯可信区间，-0.147至0.116）。手术组30天内死亡的患者百分比为9.3%，对照组为18.0%。手术组中有5名患者（3.3%）出现术后再出血和神经功能恶化。

结论

在急性脑出血后24小时内可进行手术的患者中，微创血肿清除术在180天内的功能预后优于基于指南的药物治疗。手术的效果似乎可归因于对脑叶出血的干预。（由Nico资助；Enrich ClinicalTrials.gov编号，NCT02880878。）

英文原文如下：

Abstracts

BACKGROUND  Trials of surgical evacuation of supratentorial intracerebral hemorrhages have generally shown no functional benefit. Whether early minimally invasive surgical removal would result in better outcomes than medical management is not known.

METHODS  In this multicenter, randomized trial involving patients with an acute intracerebral hemorrhage, we assessed surgical removal of the hematoma as compared with medical management. Patients who had a lobar or anterior basal ganglia hemorrhage with a hematoma volume of 30 to 80 ml were assigned, in a 1:1 ratio, within 24 hours after the time that they were last known to be well, to minimally invasive surgical removal of the hematoma plus guideline-based medical management (surgery group) or to guideline-based medical management alone (control group). The primary efficacy end point was the mean score on the utility-weighted modified Rankin scale (range, 0 to 1, with higher scores indicating better outcomes, according to patients' assessment) at 180 days, with a prespecified threshold for posterior probability of superiority of 0.975 or higher. The trial included rules for adaptation of enrollment criteria on the basis of hemorrhage location. A primary safety end point was death within 30 days after enrollment.

RESULTS  A total of 300 patients were enrolled, of whom 30.7% had anterior basal ganglia hemorrhages and 69.3% had lobar hemorrhages. After 175 patients had been enrolled, an adaptation rule was triggered, and only persons with lobar hemorrhages were enrolled. The mean score on the utility-weighted modified Rankin scale at 180 days was 0.458 in the surgery group and 0.374 in the control group (difference, 0.084; 95% Bayesian credible interval, 0.005 to 0.163; posterior probability of superiority of surgery, 0.981). The mean between-group difference was 0.127 (95% Bayesian credible interval, 0.035 to 0.219) among patients with lobar hemorrhages and -0.013 (95% Bayesian credible interval, -0.147 to 0.116) among those with anterior basal ganglia hemorrhages. The percentage of patients who had died by 30 days was 9.3% in the surgery group and 18.0% in the control group. Five patients (3.3%) in the surgery group had postoperative rebleeding and neurologic deterioration.

CONCLUSIONS  Among patients in whom surgery could be performed within 24 hours after an acute intracerebral hemorrhage, minimally invasive hematoma evacuation resulted in better functional outcomes at 180 days than those with guideline-based medical management. The effect of surgery appeared to be attributable to intervention for lobar hemorrhages. (Funded by Nico; ENRICH ClinicalTrials.gov number, NCT02880878.).

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