Department of Neurology and Neurosurgery, Brain Center, University Medical Center, Utrecht University, Utrecht, the Netherlands.
Department of Neurology, University Hospital Heidelberg, University of Heidelberg, Heidelberg, Germany.
JAMA Neurol. 2021 Feb 1;78(2):208-216. doi: 10.1001/jamaneurol.2020.3745.
In patients with space-occupying hemispheric infarction, surgical decompression reduces the risk of death and increases the chance of a favorable outcome. Uncertainties, however, still remain about the benefit of this treatment for specific patient groups.
To assess whether surgical decompression for space-occupying hemispheric infarction is associated with a reduced risk of death and an increased chance of favorable outcomes, as well as whether this association is modified by patient characteristics.
MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and the Stroke Trials Registry were searched from database inception to October 9, 2019, for English-language articles that reported on the results of randomized clinical trials of surgical decompression vs conservative treatment in patients with space-occupying hemispheric infarction.
Published and unpublished randomized clinical trials comparing surgical decompression with medical treatment alone were selected.
Patient-level data were extracted from the trial databases according to a predefined protocol and statistical analysis plan. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline and the Cochrane Collaboration's tool for assessing risk of bias were used. One-stage, mixed-effect logistic regression modeling was used for all analyses.
The primary outcome was a favorable outcome (modified Rankin Scale [mRS] score ≤3) at 1 year after stroke. Secondary outcomes included death, reasonable (mRS score ≤4) and excellent (mRS score ≤2) outcomes at 6 months and 1 year, and an ordinal shift analysis across all levels of the mRS. Variables for subgroup analyses were age, sex, presence of aphasia, stroke severity, time to randomization, and involved vascular territories.
Data from 488 patients from 7 trials from 6 countries were available for analysis. The risk of bias was considered low to moderate for 6 studies. Surgical decompression was associated with a decreased chance of death (adjusted odds ratio, 0.16; 95% CI, 0.10-0.24) and increased chance of a favorable outcome (adjusted odds ratio, 2.95; 95% CI, 1.55-5.60), without evidence of heterogeneity of treatment effect across any of the prespecified subgroups. Too few patients were treated later than 48 hours after stroke onset to allow reliable conclusions in this subgroup, and the reported proportions of elderly patients reaching a favorable outcome differed considerably among studies.
The results suggest that the benefit of surgical decompression for space-occupying hemispheric infarction is consistent across a wide range of patients. The benefit of surgery after day 2 and in elderly patients remains uncertain.
在有占位性半球梗死的患者中，手术减压降低了死亡风险并增加了获得良好结局的机会。然而，对于特定的患者群体，这种治疗的益处仍存在不确定性。
评估手术减压治疗占位性半球梗死是否与降低死亡风险和增加获得良好结局的机会相关，以及这种关联是否受患者特征的影响。
从数据库建立到 2019 年 10 月 9 日，检索 MEDLINE、Embase、Cochrane 中央对照试验注册库和卒中试验登记处，以获取关于手术减压与单纯保守治疗比较的随机临床试验结果的英文文献。
选择了已发表和未发表的比较手术减压与单独药物治疗的随机临床试验。
根据预先制定的方案和统计分析计划，从试验数据库中提取患者水平数据。使用系统评价和荟萃分析的首选报告项目（PRISMA）报告准则和 Cochrane 协作组评估偏倚风险的工具。使用单阶段混合效应逻辑回归模型进行所有分析。
主要结局是卒中后 1 年改良 Rankin 量表（mRS）评分≤3 的良好结局。次要结局包括 6 个月和 1 年时的死亡、合理（mRS 评分≤4）和良好（mRS 评分≤2）结局，以及 mRS 所有水平的等级转移分析。亚组分析的变量包括年龄、性别、失语症存在、卒中严重程度、随机分组时间和受累血管区域。
来自 6 个国家的 7 项试验的 488 名患者的数据可用于分析。6 项研究的偏倚风险被认为是低至中度的。手术减压与降低死亡风险（调整后的优势比，0.16；95%CI，0.10-0.24）和增加获得良好结局的机会（调整后的优势比，2.95；95%CI，1.55-5.60）相关，在任何预先指定的亚组中均未发现治疗效果存在异质性。由于在卒中发病后超过 48 小时接受治疗的患者太少，无法在该亚组中得出可靠的结论，并且不同研究报告的老年患者达到良好结局的比例差异很大。
结果表明，手术减压治疗占位性半球梗死的益处适用于广泛的患者。发病后第 2 天和老年患者的手术获益仍不确定。
