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意识障碍中正中神经电刺激的安全性:随机对照试验的系统评价和荟萃分析

Safety of median nerve electrical stimulation in disorders of consciousness: A systematic review and meta-analysis of randomized controlled trials.

作者信息

Gu Chunling, Shang Hongcai, Kong Yifan, Peng Mengqi, Jiang Huiru, Wang Shijia, Wei Xiaohong

机构信息

Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.

出版信息

PLoS One. 2025 Jul 31;20(7):e0324046. doi: 10.1371/journal.pone.0324046. eCollection 2025.

Abstract

BACKGROUND

Median nerve electrical stimulation (MNS) is a noninvasive treatment technique that can improve the brain functional activity of patients with disorders of consciousness (DoC) and promote their awakening. However, there is no research on whether MNS increases the incidence and severity of DoC complications. In this study, we evaluated the safety of MNS for the treatment of DoC.

METHODS

We searched relevant studies in PubMed, Cochrane, Web of Science (Medline), and Chinese databases, including CNKI, VIP, and WanFang Databases. For dichotomous outcomes, the pooled risk ratio (RR) with its 95% confidence interval (CI) was used as the effect estimate. We applied a fixed-effects or random-effects model to test the robustness of the forecast. A funnel plot was used to test for publication bias. Heterogeneity was evaluated using I². Subgroup analysis, sensitivity analysis were also performed. The quality of evidence was assessed using the GRADE approach. This study protocol has been registered in PROSPERO.

RESULTS

The results of the meta-analysis showed that MNS may not increase the incidence of complications and adverse events such as seizures, increased sympathetic activity, arrhythmia, nausea and vomiting, lethargy, pulmonary infection, intracranial hemorrhage or hematoma, and gastrointestinal bleeding in DoC patients. However, the methodological quality of most studies was poor, and accurate conclusions could not be drawn.

CONCLUSION

MNS does not increase the incidence of DoC complications and adverse events, however, the quality of evidence for it's safety is low and high-quality randomized controlled trials are needed to further confirm this conclusion.

摘要

背景

正中神经电刺激(MNS)是一种非侵入性治疗技术,可改善意识障碍(DoC)患者的脑功能活动并促进其苏醒。然而,尚无关于MNS是否会增加DoC并发症的发生率和严重程度的研究。在本研究中,我们评估了MNS治疗DoC的安全性。

方法

我们检索了PubMed、Cochrane、科学网(Medline)以及包括中国知网、维普和万方数据库在内的中文数据库中的相关研究。对于二分结果,采用合并风险比(RR)及其95%置信区间(CI)作为效应估计值。我们应用固定效应或随机效应模型来检验预测的稳健性。采用漏斗图检验发表偏倚。使用I²评估异质性。还进行了亚组分析和敏感性分析。使用GRADE方法评估证据质量。本研究方案已在国际前瞻性系统评价注册库(PROSPERO)注册。

结果

荟萃分析结果表明,MNS可能不会增加DoC患者癫痫发作、交感神经活动增强、心律失常、恶心呕吐、嗜睡、肺部感染、颅内出血或血肿以及胃肠道出血等并发症和不良事件的发生率。然而,大多数研究的方法学质量较差,无法得出准确结论。

结论

MNS不会增加DoC并发症和不良事件的发生率,然而,其安全性的证据质量较低,需要高质量的随机对照试验来进一步证实这一结论。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ada8/12312889/589c9d0604c6/pone.0324046.g001.jpg

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