远程缺血预处理在接受血运重建手术的成人烟雾病患者中的安全性和有效性：一项试点研究。
Safety and efficacy of remote ischemic conditioning in adult moyamoya disease patients undergoing revascularization surgery: a pilot study.
作者信息
Yang Heng, Hu Zhenzhen, Gao Xinjie, Su Jiabin, Jiang Hanqiang, Yang Shaoxuan, Zhang Qing, Ni Wei, Gu Yuxiang
机构信息
Department of Neurosurgery, Huashan Hospital, Fudan University, Shanghai, China.
Neurosurgical Institute, Fudan University, Shanghai, China.
出版信息
Front Neurol. 2023 Jul 28;14:1200534. doi: 10.3389/fneur.2023.1200534. eCollection 2023.
BACKGROUND AND PURPOSE
Revascularization surgery for patients with moyamoya disease (MMD) is very complicated and has a high rate of postoperative complications. This pilot study aimed to prove the safety and efficacy of remote ischemic conditioning (RIC) in adult MMD patients undergoing revascularization surgery.
METHODS
A total of 44 patients with MMD were enrolled in this single-center, open-label, prospective, parallel randomized study, including 22 patients assigned to the sham group and 22 patients assigned to the RIC group. The primary outcome was the incidence of major neurologic complications during the perioperative period. Secondary outcomes were the modified Rankin Scale (mRS) score at discharge, at 90 days post-operation, and at 1 year after the operation. The outcome of safety was the incidence of adverse events associated with RIC. Blood samples were obtained to monitor the serum concentrations of cytokines (VEGF, IL-6).
RESULTS
No subjects experienced adverse events during RIC intervention, and all patients could tolerate the RIC intervention in the perioperative period. The incidence of major neurologic complications was significantly lower in the RIC group compared with the control group (18.2% vs. 54.5%, = 0.027). The mRS score at discharge in the RIC group was also lower than the control group (0.86 ± 0.99 vs. 1.18 ± 1.22, = 0.035). In addition, the serum IL-6 level increased significantly at 7 days after bypass surgery in the control group and the serum level of VEGF at 7 days post-operation in the RIC group.
CONCLUSION
In conclusion, our study demonstrated the neuroprotective effect of RIC by reducing perioperative complications and improving cerebral blood flow in adult MMD patients undergoing revascularization surgery. Thus, RIC seems to be a potential treatment method for MMD.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, identifier: NCT05860946.
背景与目的
烟雾病（MMD）患者的血运重建手术非常复杂，术后并发症发生率很高。这项前瞻性研究旨在证实远程缺血预处理（RIC）在接受血运重建手术的成年烟雾病患者中的安全性和有效性。
方法
本单中心、开放标签、前瞻性、平行随机研究共纳入44例烟雾病患者，其中22例分配至假手术组，22例分配至RIC组。主要结局是围手术期严重神经并发症的发生率。次要结局是出院时、术后90天和术后1年的改良Rankin量表（mRS）评分。安全性结局是与RIC相关的不良事件发生率。采集血样以监测细胞因子（VEGF、IL-6）的血清浓度。
结果
在RIC干预期间，没有受试者出现不良事件，所有患者在围手术期都能耐受RIC干预。RIC组严重神经并发症的发生率显著低于对照组（18.2%对54.5%，P = 0.027）。RIC组出院时的mRS评分也低于对照组（0.86±0.99对1.18±1.22，P = 0.035）。此外，对照组搭桥手术后7天血清IL-6水平显著升高，RIC组术后7天血清VEGF水平升高。
结论
总之，我们的研究通过减少围手术期并发症和改善接受血运重建手术的成年烟雾病患者的脑血流，证实了RIC的神经保护作用。因此，RIC似乎是烟雾病的一种潜在治疗方法。
临床试验注册
ClinicalTrials.gov，标识符：NCT05860946。
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