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经皮耳迷走神经刺激治疗中风后抑郁症:一项双盲、随机、安慰剂对照试验。

Transcutaneous auricular vagus nerve stimulation for post-stroke depression: A double-blind, randomized, placebo-controlled trial.

作者信息

Liu Chang, Tang Hao, Liu Chang, Ma Jingxi, Liu Gang, Niu Lingchuan, Li Changqing, Li Jiani

机构信息

Department of Neurology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.

Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.

出版信息

J Affect Disord. 2024 Jun 1;354:82-88. doi: 10.1016/j.jad.2024.03.005. Epub 2024 Mar 5.

DOI:10.1016/j.jad.2024.03.005
PMID:38452937
Abstract

BACKGROUND

It is a well-established fact that post-stroke depression (PSD) is a prevalent condition that affects a significant proportion of individuals who have suffered a stroke. Hence, our research endeavors to explore the safety, efficacy and the potential molecular mechanism of transcutaneous auricular vagus nerve stimulation (ta-VNS) for the treatment of depression in PSD patients by conducting a double-blind, sham-controlled, randomized trial.

METHODS

Patients who had experienced strokes and exhibited depressive symptoms, with a Hamilton Depression Scale (HAMD-17) score of ≥8 and met the DSM-IV criteria, were diagnosed with PSD. A volunteer sample of participants (N = 80) were randomly divided into either the ta-VNS group (which received ta-VNS in addition to conventional treatment) or the control group (which received conventional treatment only), in a 1:1 ratio. The effectiveness of the interventions was evaluated using the 17-item Hamilton Rating Scale for Depression (HAMD-17), Zung Self-Rating Depression Scale (SDS), and Barthel Index (BI) scores. Furthermore, Plasma BDNF, CREB1, and 5-HT levels were measured before and after treatment.

RESULTS

The concomitant application of ta-VNS demonstrated a remarkable reduction in HAMD-17 and SDS scores, leading to noteworthy enhancements in patients' daily functioning, as evidenced by improved activities of daily living, at all assessed time points, in contrast to the control group (p < 0.0001). Notably, the ta-VNS group exhibited superior effects in modulating the measured neurotrophic biomarkers when compared to the control group (p < 0.05).

CONCLUSIONS

The synergistic approach of combining ta-VNS with conventional treatment has demonstrated remarkable efficacy and tolerability in managing depression following a stroke.

摘要

背景

卒中后抑郁(PSD)是一种普遍存在的疾病,影响着很大比例的卒中患者,这是一个已被充分证实的事实。因此,我们的研究旨在通过进行一项双盲、假对照、随机试验,探索经皮耳迷走神经刺激(ta-VNS)治疗PSD患者抑郁的安全性、有效性及潜在分子机制。

方法

经历过卒中且出现抑郁症状、汉密尔顿抑郁量表(HAMD-17)评分≥8且符合DSM-IV标准的患者被诊断为PSD。80名参与者的志愿者样本被随机分为ta-VNS组(除常规治疗外还接受ta-VNS)或对照组(仅接受常规治疗),比例为1:1。使用17项汉密尔顿抑郁评定量表(HAMD-17)、zung自评抑郁量表(SDS)和巴氏指数(BI)评分评估干预措施的有效性。此外,在治疗前后测量血浆脑源性神经营养因子(BDNF)、环磷腺苷效应元件结合蛋白1(CREB1)和5-羟色胺(5-HT)水平。

结果

与对照组相比,在所有评估时间点,ta-VNS的联合应用均显示HAMD-17和SDS评分显著降低,患者日常生活功能显著改善,日常生活活动能力提高(p < 0.0001)。值得注意的是,与对照组相比,ta-VNS组在调节所测神经营养生物标志物方面表现出更好的效果(p < 0.05)。

结论

ta-VNS与常规治疗相结合的协同方法在治疗卒中后抑郁方面已显示出显著的疗效和耐受性。

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