Department of Psychiatry, Stanford University Medical Center, Stanford University, 401 Quarry Road, Palo Alto, CA 94305 USA.
University of Texas Southwestern Medical School, Dallas, TX, USA.
Brain Stimul. 2014 Mar-Apr;7(2):219-25. doi: 10.1016/j.brs.2013.10.008. Epub 2013 Nov 4.
BACKGROUND: Transcranial magnetic stimulation (TMS) is a safe and effective treatment for major depression. We describe quality of life (QOL) outcomes from acute treatment with TMS, and describe the durability of benefit across 24-weeks. METHODS: Three hundred and one medication-free patients with pharmacoresistant major depression were randomized to active or sham TMS in a 6-week controlled trial. Nonresponders to the 6-week blinded phase of the study were enrolled in a 6-week open-label study without unblinding the prior treatment assignment. Responders and partial responders to both the blinded (active or sham treatment) or open acute treatment phases were tapered off TMS over three weeks, while initiating maintenance antidepressant medication monotherapy. These subjects entered the 24-week study to examine the durability of response to TMS. The Medical Outcomes Study-36 Item Short Form (SF-36) and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) were used to measure overall function and QOL. During the 24-week durability of effect study, QOL assessments were done at study entry and at the end of 24-weeks. RESULTS: Statistically significant improvement in both functional status and QOL outcomes was observed in patients treated with active TMS compared with sham TMS during the acute phase of the randomized, sham-controlled trial. Similar benefits were observed in patients who entered the open-label extension study. These improvements were sustained across the 24-week follow up study. CONCLUSIONS: Acute treatment with TMS improved functional status and QOL outcomes in patients with major depression. This clinical effect was durable in long-term follow up.
背景:经颅磁刺激(TMS)是治疗重度抑郁症的一种安全有效的方法。我们描述了 TMS 急性治疗的生活质量(QOL)结果,并描述了 24 周内的受益持久性。
方法:301 名无药物治疗的抗药性重度抑郁症患者被随机分配至 TMS 治疗组或假刺激组,进行为期 6 周的对照试验。对研究的 6 周盲法阶段无反应的患者被纳入 6 周的开放标签研究,但不解除先前治疗的分组。对盲法(TMS 或假刺激)或开放急性治疗阶段的反应者和部分反应者,在三周内逐渐减少 TMS 治疗,同时开始维持性抗抑郁药物单药治疗。这些患者进入 24 周的研究,以检查 TMS 治疗反应的持久性。采用健康调查简表 36 项(SF-36)和生活质量满意度问卷(Q-LES-Q)来衡量总体功能和 QOL。在 24 周的效应持久性研究期间,在研究入组时和 24 周结束时进行 QOL 评估。
结果:与假刺激组相比,在随机、假对照试验的急性阶段,接受 TMS 治疗的患者在功能状态和 QOL 结果方面均有显著改善。在进入开放标签扩展研究的患者中也观察到了类似的益处。这些改善在 24 周的随访研究中持续存在。
结论:TMS 急性治疗可改善重度抑郁症患者的功能状态和 QOL 结果。这种临床效果在长期随访中是持久的。