Wilting Floor Nh, Sondag Lotte, Schreuder Floris Hbm, Dammers Ruben, Klijn Catharina Jm, Boogaarts Hieronymus D
Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, Netherlands.
Department of Neurology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.
Cochrane Database Syst Rev. 2025 Jul 17;7(7):CD015387. doi: 10.1002/14651858.CD015387.pub2.
It is unknown whether surgery improves outcomes in people with spontaneous supratentorial intracerebral haemorrhage (ICH), and whether the effects of surgery differ according to the applied surgical technique. This review updated the methodology of a previous Cochrane review from 2008.
To assess the benefits and harms of surgery plus standard medical management, compared to standard medical management alone, in people with spontaneous supratentorial ICH, and to assess whether the effect of surgery differs according to the surgical technique used.
We searched Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, and five other databases to 11 March 2025. We handsearched reference lists of included studies and relevant systematic reviews, forward-tracked relevant references, and contacted trialists for additional information on unpublished or ongoing studies.
We included randomised controlled trials (RCTs) of surgery (craniotomy with haematoma evacuation, minimally invasive surgery (MIS), or decompressive craniectomy) plus standard medical management in adults with a spontaneous supratentorial ICH, compared with standard medical management alone. We excluded studies of people with secondary causes of ICH (such as trauma, a macrovascular cause, or an intracranial tumour).
Critical outcomes were: good functional outcome at end of scheduled follow-up, and all-cause mortality at end of scheduled follow-up. Important outcomes were: 30-day case fatality and health-related quality of life (HRQoL) at end of scheduled follow-up.
We used the Cochrane RoB 1 tool.
We conducted meta-analyses using random-effects models to calculate risk ratios (RR) with 95% confidence intervals (CI) for dichotomous data, and mean differences (MD) with 95% CI for continuous data. We summarised the certainty of the evidence using GRADE.
We included 24 RCTs (4597 participants). The studies were conducted in Europe, North and South America, Asia, Africa, and Australia, and were published between 1989 and 2024. Twenty-three studies examined surgery aimed at clot removal plus standard medical management versus standard medical management, of which six were included in the separate comparison of craniotomy with haematoma evacuation plus standard medical management versus standard medical management, and 14 in the comparison of MIS plus standard medical management versus standard medical management. One study examined decompressive craniectomy without haematoma evacuation plus standard medical management versus standard medical management.
Surgery aimed at clot removal plus standard medical management versus standard medical management alone Low-certainty evidence suggests that surgery aimed at clot removal may increase the chance of good functional outcome (RR 1.30, 95% CI 1.15 to 1.47; 18 studies, 4043 participants), and may reduce all-cause mortality (RR 0.79, 95% CI 0.71 to 0.88; 22 studies, 4278 participants) and 30-day case fatality (RR 0.74, 95% CI 0.60 to 0.90; 11 studies, 3179 participants). Surgery aimed at clot removal may have little to no effect on HRQoL, but the evidence is very uncertain (MD 0.03, 95% CI -0.05 to 0.11; 2 studies, 472 participants). Craniotomy with haematoma evacuation plus standard medical management versus standard medical management alone Craniotomy with haematoma evacuation may increase the chance of good functional outcome, but the evidence is very uncertain (RR 1.41, 95% CI 0.77 to 2.55; 6 studies, 853 participants). Craniotomy with haematoma evacuation likely reduces all-cause mortality (RR 0.80, 95% CI 0.67 to 0.96; 5 studies, 845 participants; moderate-certainty evidence), and may reduce 30-day case fatality (RR 0.68, 95% CI 0.46 to 1.00; 3 studies, 676 participants; low-certainty evidence), but the pooled CIs of 30-day case fatality included the possibility of no effect. Craniotomy with haematoma evacuation may result in little to no difference in HRQoL (MD 0.04, 95% CI -0.04 to 0.12; 1 study, 445 participants; low-certainty evidence). Minimally invasive surgery plus standard medical management versus standard medical management alone MIS may increase the chance of good functional outcome (RR 1.36, 95% CI 1.18 to 1.58; 10 studies, 2218 participants; low-certainty evidence), and probably reduces all-cause mortality (RR 0.71, 95% CI 0.60 to 0.84; 14 studies, 2401 participants; moderate-certainty evidence) and 30-day case fatality (RR 0.62, 95% CI 0.47 to 0.81; 7 studies, 1521 participants; moderate-certainty evidence). The evidence is very uncertain about HRQoL (MD -0.14, 95% CI -0.50 to 0.22; 1 study, 27 participants). Decompressive craniectomy plus standard medical management versus standard medical management alone Based on low-certainty evidence from one study, decompressive craniectomy may increase the chance of good functional outcome (RR 1.23, 95% CI 0.65 to 2.32; 182 participants), may reduce all-cause mortality (RR 0.74, 95% CI 0.45 to 1.19; 197 participants), and may result in little to no difference in HRQoL (MD 0.01, 95% CI -0.13 to 0.14), but the pooled CIs for these outcomes included the possibility of both benefit and harm. Decompressive craniectomy may also reduce 30-day case fatality, but the pooled CIs included the possibility of no effect (RR 0.43, 95% CI 0.19 to 1.00; 197 participants; low-certainty evidence).
AUTHORS' CONCLUSIONS: For people with spontaneous supratentorial ICH, surgery aimed at clot removal may increase the chance of achieving good functional outcome and may reduce all-cause mortality and 30-day case fatality compared to standard medical management. When the results are divided by neurosurgical approach for haematoma evacuation, craniotomy likely reduces all-cause mortality and may reduce 30-day case fatality, while its effect on good functional outcome is very uncertain. MIS may increase the chance of good functional outcome, and probably reduces all-cause mortality and 30-day case fatality. Although the effect estimates for all outcomes regarding decompressive craniectomy may suggest a beneficial effect, the pooled estimates were very imprecise and included the possibility of a harmful (good functional outcome and all-cause mortality) or no effect (30-day case fatality). Evidence on HRQoL was low or very low certainty, overall, and for each surgical technique. The certainty of the evidence was limited due to methodological shortcomings and the high risk of bias of most included studies, as well as imprecise pooled estimates and substantial heterogeneity in some analyses. More high-quality and adequately powered studies are needed to be more certain and to guide clinical practice.
This Cochrane review had no dedicated funding.
Protocol (2022) available via doi.org/10.1002/14651858.CD015387.
目前尚不清楚手术是否能改善自发性幕上脑出血(ICH)患者的预后,以及手术效果是否因所采用的手术技术而异。本综述更新了2008年之前的Cochrane综述方法。
评估与单纯标准药物治疗相比,手术联合标准药物治疗对自发性幕上ICH患者的益处和危害,并评估手术效果是否因所用手术技术而异。
我们检索了Cochrane卒中组试验注册库、CENTRAL、MEDLINE以及其他五个数据库,检索截至2025年3月11日。我们手工检索了纳入研究和相关系统评价的参考文献列表,追踪相关参考文献,并联系试验者以获取未发表或正在进行研究的更多信息。
我们纳入了针对成人自发性幕上ICH患者的手术(开颅血肿清除术、微创手术(MIS)或减压性颅骨切除术)联合标准药物治疗的随机对照试验(RCT),并与单纯标准药物治疗进行比较。我们排除了继发于ICH的患者(如创伤、大血管病因或颅内肿瘤)的研究。
关键结局指标为:预定随访结束时的良好功能结局,以及预定随访结束时的全因死亡率。重要结局指标为:30天病死率和预定随访结束时的健康相关生活质量(HRQoL)。
我们使用了Cochrane RoB 1工具。
我们采用随机效应模型进行荟萃分析,以计算二分数据的风险比(RR)及其95%置信区间(CI),以及连续数据进行平均差(MD)及其95%CI。我们使用GRADE总结证据的确定性。
我们纳入了24项RCT(4597名参与者)。这些研究在欧洲、南北美洲、亚洲、非洲和澳大利亚进行,发表时间为从1989年至2024年。23项研究比较了旨在清除血凝块的手术联合标准药物治疗与标准药物治疗,其中6项纳入了开颅血肿清除术联合标准药物治疗与标准药物治疗的单独比较,14项纳入了MIS联合标准药物治疗与标准药物治疗比较。一项研究比较了未清除血肿的减压性颅骨切除术联合标准药物治疗与标准药物治疗。
旨在清除血凝块的手术联合标准药物治疗与单纯标准药物治疗 低确定性证据表明,旨在清除血凝块的手术可能会增加获得良好功能结局的机会(RR 1.30,95%CI 1.15至1.47;18项研究,4043名参与者),并可能降低全因死亡率(RR 0.79,95%CI 0.71至0.88;22项研究,4278名参与者)和30天病死率(RR 0.74,95%CI 0.60至0.90;11项研究,3179名参与者)。旨在清除血凝块的手术对HRQoL可能几乎没有影响,但证据非常不确定(MD 0.03,95%CI -0.05至0.11;2项研究,472名参与者)。 开颅血肿清除术联合标准药物治疗与单纯标准药物治疗 开颅血肿清除术可能会增加获得良好功能结局的机会,但证据非常不确定(RR 1.41,95%CI 0.77至2.55;6项研究,853名参与者)。开颅血肿清除术可能会降低全因死亡率(RR 0.80,95%CI 0.67至0.96;5项研究,845名参与者;中等确定性证据),并可能降低30天病死率(RR 0.68,95%CI 0.46至1.00;3项研究,676名参与者;低确定性证据),但30天病死率的合并CI包括无效果的可能性。开颅血肿清除术对HRQoL可能几乎没有差异(MD 0.04,95%CI -0.04至0.12;1项研究,445名参与者;低确定性证据)。 微创手术联合标准药物治疗与单纯标准药物治疗 MIS可能会增加获得良好功能结局的机会(RR 1.36,95%CI 1.18至1.58;10项研究,2218名参与者;低确定性证据),并可能降低全因死亡率(RR 0.71,95%CI 0.60至0.84;14项研究,2401名参与者;中等确定性证据)和30天病死率(RR 0.62,95%CI 0.47至0.81;7项研究,1521名参与者;中等确定性证据)。关于HRQoL的证据非常不确定(MD -0.14,95%CI -0.50至0.22;1项研究,27名参与者)。 减压性颅骨切除术联合标准药物治疗与单纯标准药物治疗 根据一项研究的低确定性证据,减压性颅骨切除术可能会增加获得良好功能结局的机会(RR 1.23,95%CI 0.65至2.32;182名参与者),可能会降低全因死亡率(RR 0.74,95%CI 0.45至1.19;197名参与者),并且对HRQoL可能几乎没有差异(MD 0.01,95%CI -0.13至0.14),但这些结局的合并CI包括有益和有害的可能性。减压性颅骨切除术也可能降低30天病死率,但合并CI包括无效果的可能性(RR 0.43,95%CI 0.19至1.00;197名参与者;低确定性证据)。
对于自发性幕上ICH患者,与标准药物治疗相比,旨在清除血凝块的手术可能会增加获得良好功能结局的机会,并可能降低全因死亡率和30天病死率。当按血肿清除的神经外科手术方法划分结果时,开颅术可能会降低全因死亡率,并可能降低30天病死率,而其对良好功能结局的影响非常不确定。MIS可能会增加获得良好功能结局的机会,并可能降低全因死亡率和30天病死率。尽管关于减压性颅骨切除术的所有结局的效应估计可能表明有有益效果,但合并估计非常不精确,并且包括有害(良好功能结局和全因死亡率)或无效果(30天病死率)的可能性。总体而言,以及每种手术技术的HRQoL证据的确定性较低或非常低。由于方法学缺陷、大多数纳入研究的高偏倚风险、不精确的合并估计以及某些分析中的实质性异质性,证据的确定性有限。需要更多高质量和有足够效力的研究,以更确定并指导临床实践。
本Cochrane综述没有专项资助。
方案(2022年)可通过doi.org/10.1002/14651858.CD01538获得。