法国皮蒂-萨尔佩特里医院Eimad Shotar团队研究了脑膜栓塞预防慢性硬膜下血肿术后复发的疗效与安全性。相关论文于2025年6月5日发表在《美国医学会杂志》上。

脑膜中动脉（MMA）栓塞已被提出作为慢性硬膜下血肿（CSDH）的潜在治疗方法。为了评估MMA栓塞在降低CSDH复发高风险手术患者6个月时CSDH复发风险方面与标准治疗相比的疗效。研究组进行了一项采用盲法终点评估的多中心、开放标签、随机临床试验。2020年7月至2023年3月，在法国12个神经外科或综合神经外科和介入神经放射学中心招募了因CSDH复发或复发风险高的首次CSDH发作而接受手术的患者。最后一次随访是在2023年11月2日。

干预组参与者按1:1的比例随机分组，在手术7天内（干预组171例）接受MMA微粒栓塞治疗，或单独接受标准医疗护理（对照组171例）。主要终点是6个月时CSDH的复发率，由一个独立的盲法裁决委员会评估。有5个次要终点，包括6个月随访期间同侧CSDH复发的重复手术率和栓塞手术相关并发症。

342例随机患者中(中位[IQR]年龄为77[68-83]岁；274例（80.1%）男性)，308例（90.1%）完成试验。在干预组和对照组中，162例患者中有24例（14.8%）和157例患者中有33例（21.0%）分别观察到主要终点(校正后：优势比0.64；调整后的绝对差值为6%)。两组在任何次要终点上均无显著差异。干预组162例中有7例（4.3%）重复手术，对照组157例中有13例（8.3%）重复手术（P = 0.14）。171例患者中分别有3例（1.8%）和1例（0.6%）发生轻微和严重栓塞手术相关并发症。

研究结果表明，在这项随机临床试验中，在因CSDH复发或复发风险高的首次CSDH发作而接受手术的患者中，与单独进行标准医疗护理相比，MMA栓塞并没有显著降低6个月时的复发率。然而，效果估计的大小与其他最近的试验一致，包括一些证明MMA栓塞与非粘性液体栓塞剂的益处，这些研究结果可能会为未来的研究和这种治疗方法在CSDH治疗中的潜在应用提供信息。

附：英文原文

Title: Meningeal Embolization for Preventing Chronic Subdural Hematoma Recurrence After Surgery: The EMPROTECT Randomized Clinical Trial

Author: Eimad Shotar, Bertrand Mathon, Henri Salle, Aymeric Rouchaud, Charbel Mounayer, Nicolas Bricout, Jean-Paul Lejeune, Kevin Janot, Aymeric Amelot, Olivier Naggara, Alexandre Roux, Stéphane Goutagny, Alexis Guédon, Emmanuel Houdart, Hervé Brunel, Jean-Franois Hak, Lucas Troude, Henry Dufour, Anne-Laure Bernat, Titien Tuilier, Damien Bresson, Caroline Apra, Mathilde Fouet, Simon Escalard, Dorian Chauvet, Kevin Premat, Said Lebbah, Agnès Dechartres, Frédéric Clarencon, EMPROTECT Investigators, Stéphanie Lenck, Nader-Antoine Sourour, Mahmoud Elhorany, Pierre-Marie Chiaroni, Julien Allard, Eric Barberis, Mathilde Aubertin, Adnan Altayeb, Robert Burns, Sacha Bensousan, Haroun Ghannouchi, Damien Parat, Tom Boeken, Gonzague Guillaumet, Alexandru Dimancea, Hugo Trebern, Adrien Beth, Baptiste Bonnet, Romain Coudert, Yohan Ducos, Giulio Quarta Colosso, Emily Rius, Xavier Guerra, Samer Soliman, Clément Pechiné, Luca Scarcia, Vincent Degos, Alice Jacquens, Mehdi Drir, Jugurtha Mathout, Anne Sophie MONTERO, Etienne LEFEVRE, Maximilien RICHE, Pauline MARIJON, Michel Kalamarides, Alexandre Carpentier, Anne-Laure Boch, Aurélien Nouet, Vincent REINA, Bertrand Baussart, Henri MALAIZE, Wagih BEN HASSEN, Denis TRYSTRAM, Hugo GORTAIS

Issue&Volume: 2025-06-05

Abstract:

Importance  Middle meningeal artery (MMA) embolization has been proposed as a potential treatment for chronic subdural hematoma (CSDH).

Objective  To assess the efficacy of MMA embolization in reducing the risk of CSDH recurrence at 6 months compared with standard care in patients who underwent an operation and were at high risk of CSDH recurrence.

Design, Setting, and Participants  Multicenter, open-label, randomized clinical trial with blinded end point assessment. Patients who underwent an operation for CSDH recurrence or a first CSDH episode at high risk of recurrence were recruited from July 2020 to March 2023 in 12 French neurosurgical or comprehensive neurosurgical and interventional neuroradiology centers. Last follow-up took place on November 2, 2023.

Intervention  Participants were randomized 1:1 to undergo MMA embolization with microparticles within 7 days of surgery (171 patients, intervention group) or standard medical care alone (171 patients, control group).

Main Outcomes and Measures  The primary end point was the rate of CSDH recurrence at 6 months assessed by an independent, blinded adjudication committee. There were 5 secondary end points, including rates of repeat surgery for homolateral CSDH recurrence during the 6-month follow-up period and embolization procedure–related complications.

Results  Among 342 randomized patients (median [IQR] age, 77 [68-83] years; 274 [80.1%] male), 308 (90.1%) completed the trial. The primary end point was observed in 24 of 162 (14.8%) and 33 of 157 (21.0%) patients in the intervention and control groups, respectively (after imputation: odds ratio, 0.64 [95% CI, 0.36-1.14]; adjusted absolute difference, 6% [95% CI, 14% to 2%]; P=.13). The groups did not significantly differ in any of the secondary end points. Repeat surgery was performed in 7 of 162 (4.3%) and 13 of 157 (8.3%) patients in the intervention and control groups (P=.14), respectively. Minor and major embolization procedure–related complications occurred in 3 of 171 (1.8%) and 1 of 171 (0.6%) patients, respectively.

Conclusions and Relevance  In this randomized clinical trial, among patients who underwent an operation for CSDH recurrence or a first CSDH episode at high risk of recurrence, MMA embolization did not lead to a significantly lower rate of recurrence at 6 months compared with standard medical care alone. However, the magnitude of the effect estimate is consistent with other recent trials, including some that demonstrated the benefit of MMA embolization with nonadhesive liquid embolic agents, and these findings considered together may inform future studies and potential use of this therapeutic approach for CSDH management.

DOI: 10.1001/jama.2025.7583

Source: https://jamanetwork.com/journals/jama/fullarticle/2834971