俄斯特拉发大学David Netuka研究组近日取得一项新成果。经过不懈努力，他们报道了颈动脉内膜切除术中的超声溶解。相关论文于2025年3月19日发表在《英国医学杂志》上。

目的:评价在颈动脉内膜切除术中使用低强度2 MHz脉冲波超声束进行超声溶解的有效性和安全性。

设计:多中心，3期，双盲，随机对照试验。

设置:16个欧洲中心。

参与者:1004例(平均年龄68岁；在2015年8月20日至2020年10月14日期间，312人（31%为女性）入组研究，直至进行中期分析。干预措施Sonolysis (n=507) vs假手术（n=497）。

主要结果测量：主要终点是缺血性卒中、短暂性缺血性发作和30天内死亡的综合发生率。随访脑磁共振成像新发缺血性病变发生率为主要亚研究终点，颅内出血发生率为主要安全终点。

结果:首选超声溶解组作为主要终点(11例（2.2%）vs 38例（7.6%）；风险差异- 5.5%，95%置信区间(CI) - 8.3% ~ - 2.8%；P<0.001)，以及在磁共振成像亚研究中检测到新的缺血性病变(20/236 (8.5%)v 39/224 (17.4%)；风险差异为8.9%，15%至2.8%；P = 0.004)。敏感性分析结果显示，缺血性卒中的超声溶解风险比为0.25 (95% CI 0.11 ~ 0.56)， 30天内短暂性缺血性发作的超声溶解风险比为0.23 （95% CI 0.07 ~ 0.73）。超声溶解是安全的，超声溶解组中94.4%的患者在手术后30天无严重不良事件发生。结论对颈动脉内膜切除术患者行声溶术是安全的，可显著降低缺血性卒中、短暂性缺血性发作和30天内死亡的综合发生率。

附：英文原文

Title: Sonolysis during carotid endarterectomy: randomised controlled trial

Author: David koloudík, Tomá Hrbá, Martin Ková, Vladimír Bene, Jií Fiedler, Mattia Branca, Jean-Benoit Rossel, David Netuka

Issue&Volume: 2025/03/19

Abstract: Objective To evaluate the effectiveness and safety of sonolysis using a low intensity 2 MHz pulsed wave ultrasound beam during carotid endarterectomy.

Design Multicentre, phase 3, double blind, randomised controlled trial.

Setting 16 European centres.

Participants 1004 patients (mean age 68 years; 312 (31%) female) were enrolled in the study between 20 August 2015 and 14 October 2020 until the interim analysis was performed.

Interventions Sonolysis (n=507) versus sham procedure (n=497).

Main outcome measures The primary endpoint was the composite incidence of ischaemic stroke, transient ischaemic attack, and death within 30 days. The incidence of new ischaemic lesions on follow-up brain magnetic resonance imaging was the main substudy endpoint, and incidence of intracranial bleeding was the main safety endpoint.

Results The results favoured the sonolysis group for the primary endpoint (11 (2.2%) v 38 (7.6%); risk difference 5.5%, 95% confidence interval (CI) 8.3% to 2.8%; P<0.001), as well as in the substudy for magnetic resonance imaging detected new ischaemic lesions (20/236 (8.5%) v 39/224 (17.4%); risk difference 8.9%, 15% to 2.8%; P=0.004). Sensitivity analysis resulted in a risk ratio for sonolysis of 0.25 (95% CI 0.11 to 0.56) for ischaemic stroke and 0.23 (0.07 to 0.73) for transient ischaemic attack within 30 days. Sonolysis was found to be safe, and 94.4% of patients in the sonolysis group were free from serious adverse events 30 days after the procedure.

Conclusion Sonolysis was safe for patients undergoing carotid endarterectomy and resulted in a significant reduction in the composite incidence of ischaemic stroke, transient ischaemic attack, and death within 30 days.

DOI: 10.1136/bmj-2024-082750

Source: https://www.bmj.com/content/388/bmj-2024-082750