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非侵入性神经调节技术与肉毒杆菌毒素注射治疗中风后痉挛和运动功能的比较疗效及可接受性:一项随机对照试验的网状Meta分析

Comparative efficacy and acceptability of non-invasive neuromodulation technologies and botulinum toxin injections for post-stroke spasticity and motor function: a network meta-analysis of randomised controlled trials.

作者信息

Huang Jiapeng, Bao Chuncha, Chen Yin, Zhu Wenyi, Zhang Kexin, Liu Chunlong, Tang Chunzhi

机构信息

Clinical Medical College of Acupuncture-Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.

Department of Rehabilitation Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, China.

出版信息

EClinicalMedicine. 2024 Dec 27;80:103034. doi: 10.1016/j.eclinm.2024.103034. eCollection 2025 Feb.

DOI:10.1016/j.eclinm.2024.103034
PMID:39831129
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11741030/
Abstract

BACKGROUND

Non-invasive neuromodulation is a promising approach for improving spasticity and motor function after stroke. However, it is still unclear which type of non-invasive neuromodulation is effective and evidence of important differences between them and botulinum toxin (BoNT) injection is limited. We aimed to assess the comparative efficacy and acceptability of non-invasive neuromodulation technologies and BoNT for post-stroke spasticity and motor function.

METHODS

In this network meta-analysis, Cochrane Library, EMBASE, MEDLINE, Web of Science, Scopus, CNKI, and Wan Fang Data were searched from the earliest records to 8 October 2024. Randomised controlled trials that compared any type of non-invasive neuromodulation therapies, BoNT, and control treatments (including sham or no stimulation/injection) for post-stroke spasticity measured by modified Ashworth scale (MAS) were included. MAS, motor function, and acceptability were pooled using random-effects model with summary weighted mean difference (WMD) or risk ratios (RR) alongside 95% confidence interval (CI). Ranking probabilities of the treatments were estimated. Clinical importance was categorized as definite, probable, possible, or definitely not, considering the relationship between effect measures (95% CI) and minimal clinically important difference (1, 6, and 1.5 points for MAS, motor function, and acceptability, respectively). The quality of evidence was assessed using CINeMA online web. PROSPERO registration CRD42024543494.

FINDINGS

6260 studies were identified and 185 trials (11,185 participants; 12 interventions) were included. Compared with control treatments, BoNT, high- and low-frequency repetitive transcranial magnetic stimulation (HFrTMS and LFrTMS), and anodal, cathodal, and dual transcranial direct current stimulation (atDCS, ctDCS, and dtDCS) significantly improved spasticity at short-term follow-up (WMD range -0.81 to -0.31), but did not achieve clinical importance. At mid-term, ctDCS (WMD = -2.00; 95% CI: -3.03, -0.97) and dtDCS (WMD = -1.62; 95% CI: -3.22, -0.02) were more efficacious than control treatments in reducing post-stroke spasticity with probable clinical importance. For motor function, atDCS, ctDCS, and dtDCS were more efficacious than control treatments (WMD range 6.29-13.00), with probable clinical importance, while BoNT, HFrTMS, and LFrTMS with possible clinical importance (WMD range 3.42-5.28). Various modalities have comparable acceptability to control treatments (RR range 0.48-1.46). Confidence in accordance with CINeMA ranged from high to low. Sensitivity and meta-regression analyses on limb measured, cointervention, and stroke stage confirmed the main findings of this study.

INTERPRETATION

Taken together with clinical importance, evidence available supports three forms of tDCS as effective treatments for post-stroke spasticity and/or motor impairments, whereas BoNT, HFrTMS, and LFrTMS for motor impairments. These modalities could be considered alongside rehabilitation interventions as core treatments for post-stroke spasticity and motor impairments.

FUNDING

China Postdoctoral Science Foundation (2024M752230).

摘要

背景

非侵入性神经调节是改善卒中后痉挛和运动功能的一种有前景的方法。然而,哪种类型的非侵入性神经调节有效,以及它们与肉毒杆菌毒素(BoNT)注射之间重要差异的证据仍然有限。我们旨在评估非侵入性神经调节技术和BoNT对卒中后痉挛和运动功能的比较疗效及可接受性。

方法

在这项网状Meta分析中,检索了Cochrane图书馆、EMBASE、MEDLINE、Web of Science、Scopus、中国知网和万方数据,检索时间从最早记录至2024年10月8日。纳入了比较任何类型的非侵入性神经调节疗法、BoNT和对照治疗(包括假刺激或无刺激/注射)对卒中后痉挛(通过改良Ashworth量表(MAS)测量)的随机对照试验。使用随机效应模型合并MAS、运动功能和可接受性,汇总加权均数差(WMD)或风险比(RR)以及95%置信区间(CI)。估计治疗的排序概率。考虑效应测量(95%CI)与最小临床重要差异(MAS、运动功能和可接受性分别为1、6和1.5分)之间的关系,将临床重要性分为肯定、可能、可能不或肯定不。使用CINeMA在线网络评估证据质量。PROSPERO注册号CRD42024543494。

结果

共识别出6260项研究,纳入185项试验(11185名参与者;12种干预措施)。与对照治疗相比,BoNT、高频和低频重复经颅磁刺激(HFrTMS和LFrTMS)以及阳极、阴极和双相经颅直流电刺激(atDCS、ctDCS和dtDCS)在短期随访时显著改善了痉挛(WMD范围为-0.81至-0.31),但未达到临床重要性。在中期,ctDCS(WMD = -2.00;95%CI:-3.03,-0.97)和dtDCS(WMD = -1.62;95%CI:-3.22,-0.02)在降低卒中后痉挛方面比对照治疗更有效,具有可能的临床重要性。对于运动功能,atDCS、ctDCS和dtDCS比对照治疗更有效(WMD范围为6.29 - 13.00),具有可能的临床重要性,而BoNT、HFrTMS和LFrTMS具有可能的临床重要性(WMD范围为3.42 - 5.28)。各种方式与对照治疗的可接受性相当(RR范围为0.48 - 1.46)。根据CINeMA的可信度从高到低。对测量肢体、联合干预和卒中阶段的敏感性和Meta回归分析证实了本研究的主要结果。

解读

结合临床重要性来看,现有证据支持三种形式的经颅直流电刺激作为治疗卒中后痉挛和/或运动障碍的有效方法,而BoNT、HFrTMS和LFrTMS用于治疗运动障碍。这些方式可与康复干预一起被视为卒中后痉挛和运动障碍的核心治疗方法。

资助

中国博士后科学基金(2024M752230)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9d4/11741030/700dd5cf007c/gr5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9d4/11741030/041e91b50c41/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9d4/11741030/2cc56433e418/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9d4/11741030/80a0c540b99c/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9d4/11741030/4071e5ccea3b/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9d4/11741030/700dd5cf007c/gr5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9d4/11741030/041e91b50c41/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9d4/11741030/2cc56433e418/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9d4/11741030/80a0c540b99c/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9d4/11741030/4071e5ccea3b/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9d4/11741030/700dd5cf007c/gr5.jpg

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