经皮耳迷走神经刺激治疗癫痫抑郁的有效性和安全性。

IF 2.3 3区 医学 Q2 BEHAVIORAL SCIENCES
Zheng Yan Ran Xu , Jia Jia Fang , Xiao Qin Fan , Long Long Xu , Gui Fang Jin , Mei Hua Lei , Yu Fei Wang , Jun Biao Liu , Fang Dong , Lu Rong Jiang , Yi Guo
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引用次数: 0

摘要

目的:评价经皮耳迷走神经刺激(taVNS)治疗癫痫(PWE)轻、中度抑郁的有效性和安全性。方法:在中国东部地区进行单臂、前瞻性、多中心、前后对照研究。4周基线期后,轻度至中度抑郁的PWE开始使用taVNS治疗,每天3次,每次30分钟,持续12周。主要结果测量是24项汉密尔顿抑郁评定量表(HAMD)得分从基线到第12周的变化。次要结局包括第12周抑郁症的缓解率和缓解率,以及14项汉密尔顿焦虑评定量表(HAMA)、匹兹堡睡眠质量指数(PSQI)和癫痫生活质量量表-31 (QOLIE-31)评分的变化,以及第4周和第12周与基线相比的癫痫发作频率。记录不良事件(ae)以评估taVNS的安全性。采用改良的意向治疗分析(Intention-To-Treat, mITT)和按方案分析(Per-Protocol, PP)。结果:69名参与者被纳入本研究。其中61例(88.4%)完成了4周治疗期,50例(72.5%)完成了12周治疗期。在mITT分析中,HAMD评分显著降低(4.54±7.44)(p)。结论:本研究提示taVNS可有效改善PWE患者的抑郁症状。这可能是一种有效和安全的治疗轻至中度抑郁症的PWE。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Effectiveness and safety of transcutaneous auricular vagus nerve stimulation for depression in patients with epilepsy

Objective

Our study aimed to evaluate the effectiveness and safety of transcutaneous auricular vagus nerve stimulation (taVNS) for treating mild to moderate depression in patients with epilepsy (PWE).

Methods

A single-arm, prospective, multi-center, pre-post controlled study was conducted in Eastern China. After a four-week baseline period, PWE with mild to moderate depression began treatment with taVNS, administered for 30 min, three times daily, over a 12-week period. The primary outcome measure was the change in 24-item Hamilton Depression Rating Scale (HAMD) scores from baseline to week 12. Secondary outcomes included the response and remission rates for depression at week 12, as well as changes in the 14-item Hamilton Anxiety Rating Scale (HAMA), the Pittsburgh Sleep Quality Index (PSQI), and the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) scores, and seizure frequency at weeks 4 and 12 compared to baseline. Adverse events (AEs) were recorded to assess the safety of taVNS. Both modified Intention-To-Treat (mITT) and Per-Protocol (PP) analyses were employed.

Results

Sixty-nine participants were enrolled in this study. Of these, 61 (88.4 %) completed the 4-week treatment phase, and 50 (72.5 %) finished the 12-week treatment phase. In the mITT analysis, HAMD scores significantly decreased by 4.54 ± 7.44 (p < 0.001) from baseline to week 12, with clinical response in 16 (26.2 %) and remission in 15 (24.6 %) patients. HAMA scores also decreased significantly by week 4 (3.23 ± 5.18, p < 0.001) and week 12 (4.95 ± 6.78, p < 0.001). PSQI scores and seizure frequency showed non-significant changes at week 4, but seizure frequency decreased significantly by week 12 (0.03 ± 10.47, p = 0.038). In the PP analysis, similar improvements were observed. After 12 weeks of taVNS compared to baseline, HAMD scores decreased significantly by 5.32 ± 8.98 (p < 0.001), with 32 % of patients achieving a clinical response and 24 % achieving clinical remission. And HAMA scores also decreased by 5.66 ± 7.54 (p < 0.001), seizure frequency by 0.14 ± 11.03 (p = 0.018), and PSQI scores by 1.06 ± 4.14 (p = 0.076).There was a significant increase in QOLIE-31 scores by 5.17 ± 14.71 (p = 0.020). Ten (14.5 %) patients experienced non-serious adverse events, the most common of which was ear pain (n = 4); one patient withdrew due to tinnitus enhancement; all resolved after reducing the stimulation intensity or stopping the treatment.

Conclusion

Our study suggests that taVNS may effectively improve depressive symptoms in PWE. This may be an efficacious and safe treatment for mild to moderate depression in PWE.
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来源期刊
Epilepsy & Behavior
Epilepsy & Behavior 医学-行为科学
CiteScore
5.40
自引率
15.40%
发文量
385
审稿时长
43 days
期刊介绍: Epilepsy & Behavior is the fastest-growing international journal uniquely devoted to the rapid dissemination of the most current information available on the behavioral aspects of seizures and epilepsy. Epilepsy & Behavior presents original peer-reviewed articles based on laboratory and clinical research. Topics are drawn from a variety of fields, including clinical neurology, neurosurgery, neuropsychiatry, neuropsychology, neurophysiology, neuropharmacology, and neuroimaging. From September 2012 Epilepsy & Behavior stopped accepting Case Reports for publication in the journal. From this date authors who submit to Epilepsy & Behavior will be offered a transfer or asked to resubmit their Case Reports to its new sister journal, Epilepsy & Behavior Case Reports.
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