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斯堪尼亚加速间歇性θ波爆发实施研究(SATIS)——加速治疗方案的经验教训。

The Scania Accelerated Intermittent Theta-burst Implementation Study (SATIS)-Lessons from an accelerated treatment protocol.

作者信息

Persson Marcus, Fabri Viktor, Reijbrandt Alexander, Lexén Annika, Eriksson Hans, Movahed Rad Pouya

机构信息

University Psychiatric Department, Helsingborg, Sweden.

Department of Adult Psychiatry, Malmö, Sweden.

出版信息

PLoS One. 2025 Jan 2;20(1):e0316339. doi: 10.1371/journal.pone.0316339. eCollection 2025.

DOI:10.1371/journal.pone.0316339
PMID:39746089
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11694994/
Abstract

BACKGROUND AND OBJECTIVE

The Scania Accelerated Intermittent Theta-burst Implementation Study (SATIS) aimed to investigate the tolerability, preliminary effectiveness, and practical feasibility of an accelerated intermittent theta burst stimulation (aTBS) protocol in treating depression.

METHODS

We used an open-label observational design, recruiting 20 patients (aged 19-84 years) from two public brain stimulation centers in Sweden. During the five-day treatment period and at a follow-up visit after 30 days we closely monitored adverse events and collected self-rated side effect data. Objective (MADRS, CGI) and subjective (MADRS-S) measures of symptoms and functioning (EQ-5D) were also assessed. Feasibility was evaluated using direct patient ratings combined with a qualitative approach evaluating staff experience.

RESULTS

All patients reported adverse events at some point, the most common being headache (18/20 patients), but they were generally transient. MADRS scores decreased from 28.4 (min = 17, max = 38. SD = 6.9) at baseline to 20.0 (min = 1, max = 42. SD = 11.6) after the last day of treatment. 25% (n = 5) met the response criteria, with a mean time to response of 2.2 days (min = 1, max = 3. SD = 1.1). The practical arrangements surrounding this new treatment proved challenging for the organization, but patients reported few practical problems.

CONCLUSION

SATIS provided further insights into the potential benefits and challenges associated with aTBS protocols. Effectiveness and drop-out rates were comparable to national data of conventional iTBS, but with a markedly faster time to response. More resources were required than anticipated, increasing the clinical workload.

摘要

背景与目的

斯堪尼亚加速间歇性theta波爆发刺激实施研究(SATIS)旨在调查加速间歇性theta波爆发刺激(aTBS)方案治疗抑郁症的耐受性、初步有效性和实际可行性。

方法

我们采用开放标签观察性设计,从瑞典的两个公共脑刺激中心招募了20名患者(年龄19 - 84岁)。在为期五天的治疗期以及30天后的随访中,我们密切监测不良事件并收集自评副作用数据。还评估了症状和功能的客观指标(MADRS、CGI)以及主观指标(MADRS - S)(EQ - 5D)。通过直接患者评分结合评估工作人员经验的定性方法来评估可行性。

结果

所有患者在某些时候都报告了不良事件,最常见的是头痛(20名患者中的18名),但这些不良事件通常是短暂的。MADRS评分从基线时的28.4(最小值 = 17,最大值 = 38,标准差 = 6.9)降至治疗最后一天后的20.0(最小值 = 1,最大值 = 42,标准差 = 11.6)。25%(n = 5)的患者达到缓解标准,平均缓解时间为2.2天(最小值 = 1,最大值 = 3,标准差 = 1.1)。围绕这种新治疗的实际安排对机构来说具有挑战性,但患者报告的实际问题较少。

结论

SATIS进一步深入了解了与aTBS方案相关的潜在益处和挑战。有效性和脱落率与传统间歇性theta波爆发刺激(iTBS)的全国数据相当,但缓解时间明显更快。所需资源比预期更多,增加了临床工作量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff0d/11694994/c7bcffc56a7d/pone.0316339.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff0d/11694994/bfd7965490db/pone.0316339.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff0d/11694994/b6502dab41ea/pone.0316339.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff0d/11694994/c7bcffc56a7d/pone.0316339.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff0d/11694994/bfd7965490db/pone.0316339.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff0d/11694994/b6502dab41ea/pone.0316339.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff0d/11694994/c7bcffc56a7d/pone.0316339.g003.jpg

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