迷走神经刺激对上运动神经元损伤后上肢运动功能的疗效和安全性：一项随机对照试验的荟萃分析。

Efficacy and safety of vagus nerve stimulation on upper extremity motor function in patients with stroke: A meta-analysis of randomized controlled trials.

机构信息

Department of Rehabilitation Medicine, The Affiliated Suzhou Hospital of Nanjing University Medical School, Jiangsu, China.

Department of Rehabilitation Medicine, Affiliated Maternity and Child Health Care Hospital of Nantong University, Jiangsu, China.

出版信息

NeuroRehabilitation. 2023;53(3):253-267. doi: 10.3233/NRE-230106.

DOI:10.3233/NRE-230106

PMID:37694313

Abstract

BACKGROUND

In 2021, the U.S. Food and Drug Administration (FDA) approved paired vagus nerve stimulation (VNS) for patients with moderate-to-severe upper extremity motor impairments following chronic ischemic stroke.

OBJECTIVE

Previous meta-analyses have shown that VNS may impact stroke rehabilitation, but each has some limitations.

METHODS

PubMed, Ovid, Cochrane Library, ScienceDirect, Web of Science and WHO ICTRP databases were searched until July 14, 2022 for randomized controlled trials (RCTs). We defined primary outcomes as Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and Wolf Motor Function Test (WMFT). Subgroup analyses included types of VNS, time since onset and long-term effects. Secondary outcomes included adverse events of VNS.

RESULTS

Eight RCTs involving 266 patients were analyzed, of which five used direct VNS and three transcutaneous auricular VNS. The results revealed that VNS enhanced upper extremity function via FMA-UE (SMD = 0.73; 95% CI: 0.48 to 0.99; P < 0.00001) and WMFT (SMD = 0.82; 95% CI:0.52 to 1.13; P < 0.00001) in comparison to the control group, but showed no significant change on long-term effects of FMA-UE (SMD = 0.69; 95% CI: - 0.06 to 1.44; P = 0.07). There was no difference in adverse events between the VNS and control groups (RR = 1.16; 95% CI: 0.46 to 2.92; P = 0.74).

CONCLUSION

For stroke victims with upper limb disabilities, VNS paired with rehabilitation was significantly safe and effective. More high-quality multicentric RCTs are needed to validate this conclusion.

摘要

背景

2021 年，美国食品和药物管理局（FDA）批准了双侧迷走神经刺激（VNS）用于治疗慢性缺血性脑卒中后中重度上肢运动障碍的患者。

目的

先前的荟萃分析表明 VNS 可能对脑卒中康复有影响，但每项分析都存在一些局限性。

方法

检索 PubMed、Ovid、Cochrane 图书馆、ScienceDirect、Web of Science 和世界卫生组织 ICTRP 数据库，检索时间截至 2022 年 7 月 14 日，以纳入随机对照试验（RCT）。我们将主要结局定义为上肢 Fugl-Meyer 评估（FMA-UE）和 Wolf 运动功能测试（WMFT）。亚组分析包括 VNS 的类型、发病后时间和长期效果。次要结局包括 VNS 的不良反应。

结果

共纳入 8 项 RCT，涉及 266 例患者，其中 5 项使用直接 VNS，3 项使用经皮耳迷走神经刺激（transcutaneous auricular VNS）。结果显示，与对照组相比，VNS 通过 FMA-UE（SMD=0.73；95%CI：0.48 至 0.99；P<0.00001）和 WMFT（SMD=0.82；95%CI：0.52 至 1.13；P<0.00001）提高了上肢功能，但在 FMA-UE 的长期效果上无显著差异（SMD=0.69；95%CI：-0.06 至 1.44；P=0.07）。VNS 组和对照组的不良反应发生率无差异（RR=1.16；95%CI：0.46 至 2.92；P=0.74）。