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美国食品和药物管理局批准后经颅磁刺激在临床实践中的疗效:在学术医疗中心观察到的前 100 例连续抑郁症病例的结果。

Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center.

机构信息

Philadelphia VA Medical Center, Department of Behavioral Health, Philadelphia, PA 19104, USA.

出版信息

J Clin Psychiatry. 2012 Apr;73(4):e567-73. doi: 10.4088/JCP.11m07413.

DOI:10.4088/JCP.11m07413
PMID:22579164
Abstract

INTRODUCTION

Transcranial magnetic stimulation (TMS) is a US Food and Drug Administration-approved treatment for major depressive disorder (MDD) in patients who have not responded to 1 adequate antidepressant trial in the current episode. In a retrospective cohort study, we examined the effectiveness and safety of TMS in the first 100 consecutive patients treated for depression (full DSM-IV criteria for major depressive episode in either major depressive disorder or bipolar disorder) at an academic medical center between July 21, 2008, and March 25, 2011.

METHOD

TMS was flexibly dosed in a course of up to 30 sessions, adjunctive to current medications, for 85 patients treated for acute depression. The primary outcomes were response and remission rates at treatment end point as measured by the Clinical Global Impressions-Improvement scale (CGI-I) at 6 weeks. Secondary outcomes included change in the Hamilton Depression Rating Scale (HDRS); Quick Inventory of Depressive Symptomatology, self-report (QIDS-SR); Beck Depression Inventory (BDI); Beck Anxiety Inventory (BAI); and the Sheehan Disability Scale (SDS). Enduring benefit was assessed over 6 months in patients receiving maintenance TMS treatment. Data from 12 patients who received TMS as maintenance or continuation treatment after prior electroconvulsive therapy (ECT) or TMS given in a clinical trial setting were also reviewed.

RESULTS

The clinical cohort was treatment resistant, with a mean of 3.4 failed adequate trials in the current episode. Thirty-one individuals had received prior lifetime ECT, and 60% had a history of psychiatric hospitalization. The CGI-I response rate was 50.6% and the remission rate was 24.7% at 6 weeks. The mean change was -7.8 points in HDRS score, -5.4 in QIDS-SR, -11.4 in BDI, -5.8 in BAI, and -6.9 in SDS. The HDRS response and remission rates were 41.2% and 35.3%, respectively. Forty-two patients (49%) entered 6 months of maintenance TMS treatment. Sixty-two percent (26/42 patients) maintained their responder status at the last assessment during the maintenance treatment. TMS treatment was well tolerated, with a discontinuation rate of 3% in the acute treatment phase. No serious adverse events related to TMS were observed during acute or maintenance treatment.

CONCLUSIONS

Adjunctive TMS was found to be safe and effective in both acute and maintenance treatment of patients with treatment-resistant depression.

摘要

简介

经颅磁刺激(TMS)是美国食品和药物管理局批准的治疗方法,适用于当前发作期间对 1 种以上抗抑郁药治疗无反应的重度抑郁症(MDD)患者。在一项回顾性队列研究中,我们研究了在学术医疗中心对 2008 年 7 月 21 日至 2011 年 3 月 25 日期间接受治疗的 100 例连续抑郁患者(单相重性抑郁障碍或双相障碍的 DSM-IV 重性抑郁发作的完整标准)进行 TMS 治疗的有效性和安全性。

方法

TMS 以灵活的剂量在 30 个疗程内给药,与当前药物联合使用,治疗 85 例急性抑郁患者。主要终点是治疗结束时临床总体印象-改善量表(CGI-I)在 6 周时的反应率和缓解率。次要终点包括汉密尔顿抑郁量表(HDRS)评分变化;抑郁症状快速自评量表(QIDS-SR);贝克抑郁量表(BDI);贝克焦虑量表(BAI);和 Sheehan 残疾量表(SDS)。对接受维持性 TMS 治疗的患者进行了 6 个月的持久获益评估。还回顾了 12 例在先前电抽搐治疗(ECT)后接受 TMS 维持或延续治疗或在临床试验环境下接受 TMS 治疗的患者的数据。

结果

临床队列具有治疗抵抗性,当前发作中有 3.4 次充分治疗失败。31 例患者曾接受过终身 ECT,60%有精神科住院史。CGI-I 反应率为 50.6%,6 周时缓解率为 24.7%。HDRS 评分平均下降 7.8 分,QIDS-SR 下降 5.4 分,BDI 下降 11.4 分,BAI 下降 5.8 分,SDS 下降 6.9 分。HDRS 反应率和缓解率分别为 41.2%和 35.3%。42 例患者(49%)接受了 6 个月的维持性 TMS 治疗。42 例患者中有 62%(26 例)在维持治疗期间的最后一次评估中保持了应答者状态。TMS 治疗耐受性良好,急性治疗阶段的停药率为 3%。在急性或维持治疗期间未观察到与 TMS 相关的严重不良事件。

结论

辅助性 TMS 在治疗抵抗性抑郁症患者的急性和维持治疗中均被证明是安全有效的。

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