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两种经颅磁刺激治疗方案治疗重度抑郁症的临床疗效比较。

Comparison of clinical outcomes with two Transcranial Magnetic Stimulation treatment protocols for major depressive disorder.

机构信息

Butler Hospital, Providence, RI, USA; Brown University, Department of Psychiatry and Human Behavior, Providence, RI, USA.

Sheppard Pratt Health System, Baltimore, MD, USA; Department of Psychiatry, University of Maryland, Baltimore, MD, USA.

出版信息

Brain Stimul. 2021 Jan-Feb;14(1):173-180. doi: 10.1016/j.brs.2020.12.003. Epub 2020 Dec 17.

DOI:10.1016/j.brs.2020.12.003
PMID:33346068
Abstract

BACKGROUND

Transcranial magnetic stimulation (TMS) is an effective treatment for major depressive disorder (MDD). The rest time between pulse trains is the inter-train interval (ITI). Since 2016, some TMS clinicians have adopted a stimulation protocol with shorter ITIs than were used in regulatory clinical trials.

OBJECTIVE

To contrast treatment outcomes with the Standard TMS protocol (38.5 min per session) and the "Dash" protocol, which, at the shortest ITI, has a session duration of 18.75 min.

METHODS

Registry data were collected at 103 practice sites. Of 7759 participants, 5010 were included in an intent-to-treat (ITT) sample, defined as a primary MDD diagnosis, age ≥ 18, and completion of the PHQ-9 before TMS and with at least one PHQ-9 assessment after baseline. Completers (N = 3814) were responders or had received ≥ 20 sessions and had an end of acute treatment PHQ-9 assessment. Within the ITT sample, 613 patients were treated with the Standard NeuroStar 38-min protocol and 1493 patients with the new Dash protocol. CGI-S ratings were obtained in smaller samples. Treatment outcomes were also examined in subgroups considered Completers, as well as the subgroups who met criteria for Full Adherence to the Standard or Dash protocol parameters.

RESULTS

In the ITT, Completer, and Fully Adherent samples, response (58-72%) and remission (28-53%) rates were notably high across PHQ-9 and CGI-S ratings. The Standard and Dash protocols did not differ in number of treatment sessions, and both manifested strong antidepressant effects.

CONCLUSIONS

The Standard and Dash protocols did not meaningfully differ in efficacy.

摘要

背景

经颅磁刺激(TMS)是治疗重度抑郁症(MDD)的有效方法。脉冲串之间的休息时间为脉冲串间隔(ITI)。自 2016 年以来,一些 TMS 临床医生采用了 ITI 短于监管临床试验中使用的刺激方案。

目的

对比标准 TMS 方案(每次治疗 38.5 分钟)和“Dash”方案的治疗效果,最短 ITI 时,Dash 方案的治疗时间为 18.75 分钟。

方法

在 103 个实践地点收集了注册数据。在 7759 名参与者中,有 5010 名被纳入意向治疗(ITT)样本,定义为主要 MDD 诊断、年龄≥18 岁,并且在 TMS 之前完成了 PHQ-9 量表,并在基线后至少有一次 PHQ-9 评估。完成者(N=3814)为应答者或接受了≥20 次治疗,并且在急性治疗结束时进行了 PHQ-9 评估。在 ITT 样本中,613 名患者接受了标准的 NeuroStar 38 分钟方案治疗,1493 名患者接受了新的 Dash 方案治疗。在较小的样本中获得了 CGI-S 评分。还在考虑为完成者的亚组,以及符合标准或 Dash 方案参数完全依从性的亚组中检查了治疗结果。

结果

在 ITT、完成者和完全依从者样本中,PHQ-9 和 CGI-S 评分的反应率(58%-72%)和缓解率(28%-53%)均很高。标准和 Dash 方案在治疗次数上没有差异,并且都表现出了很强的抗抑郁效果。

结论

标准和 Dash 方案在疗效上没有显著差异。

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