Nie Wenhong, Jiang Wei, Huang Hao, Xu Guanghui, Hu Qi, Zhou Hui, Zhang Wentai, Wu Jiwei, Chen Xuexia
Department of Neurosurgery, Guang'an People's Hospital, Guang'an, China.
Department of Thoracic Surgery, Peking University First Hospital, Beijing, China.
J Neurol. 2025 Apr 2;272(4):309. doi: 10.1007/s00415-025-13029-9.
This study aims to synthesise data from randomized controlled trials (RCTs) to evaluate the efficacy and safety of middle meningeal artery embolization (MMAE) in the treatment of nonacute subdural hematoma (SDH).
We systematically searched electronic databases for RCTs comparing the efficacy and safety of MMAE with conventional treatment (usual care with or without surgery) for nonacute SDH. The primary efficacy outcome was treatment failure. Secondary efficacy outcomes included changes in hematoma volume, thickness, and functional independence. The primary safety outcome was severe adverse events, and the secondary safety outcome was mortality. Pooled analyses were conducted using risk ratios (RRs) and their 95% confidence intervals (CIs) with random effects model. Trial sequential analysis (TSA) employed to assess the robustness of the evidence.
Six RCTs with 1481 patients were included in the final analysis. Compared to conventional treatment groups, the proportion of treatment failure were lower in the adjunctive MMAE group (RR 0.48, [95% CI 0.34-0.68]), with TSA suggesting sufficient evidence. There was no significant difference in the risk of severe adverse events between the MMAE and conventional treatment groups (RR 0.85, [95% CI 0.63-1.15]). No significant differences were found in secondary outcomes. Further analysis showed that MMAE plus surgery also significantly reduced the proportion of treatment failure compared to surgery alone (RR 0.55, [95% CI 0.34-0.91]), without increasing severe adverse events. In the TSA, the cumulative z-line crossed the boundary for effect.
MMAE significantly reduces the risk of treatment failure in patients with nonacute SDH, without increasing the incidence of severe adverse events.
本研究旨在综合随机对照试验(RCT)的数据,以评估脑膜中动脉栓塞术(MMAE)治疗非急性硬膜下血肿(SDH)的疗效和安全性。
我们系统检索电子数据库,查找比较MMAE与传统治疗(常规护理,有或无手术)治疗非急性SDH疗效和安全性的RCT。主要疗效结局为治疗失败。次要疗效结局包括血肿体积、厚度变化及功能独立性。主要安全结局为严重不良事件,次要安全结局为死亡率。采用风险比(RRs)及其95%置信区间(CIs)的随机效应模型进行汇总分析。采用试验序贯分析(TSA)评估证据的稳健性。
最终分析纳入了6项RCT,共1481例患者。与传统治疗组相比,辅助MMAE组治疗失败的比例较低(RR 0.48,[95%CI 0.34 - 0.68]),TSA提示证据充分。MMAE组与传统治疗组严重不良事件风险无显著差异(RR 0.85,[95%CI 0.63 - 1.15])。次要结局未发现显著差异。进一步分析表明,与单纯手术相比,MMAE联合手术也显著降低了治疗失败的比例(RR 0.55,[95%CI 0.34 - 0.91]),且未增加严重不良事件。在TSA中,累积z线越过了效应边界。
MMAE显著降低非急性SDH患者的治疗失败风险,且不增加严重不良事件的发生率。