增效重复经颅磁刺激治疗重度抑郁症（MDD）的疗效、安全性和耐受性：克罗地亚的一项前瞻性队列研究

Efficacy, Safety and Tolerability of Augmentative rTMS in Treatment of Major Depressive Disorder (MDD): A Prospective Cohort Study in Croatia.

作者信息

Filipcic Igor, Milovac Zeljko, Sucic Strahimir, Gajsak Tomislav, Filipcic Ivona Simunovic, Ivezic Ena, Aljinovic Vjekoslav, Orgulan Ivana, Penic Sandra Zecevic, Bajic Zarko

机构信息

Psychiatric Hospital "Sveti Ivan", Jankomir 11, pp68, HR-10 090 Zagreb, Croatia,

出版信息

Psychiatr Danub. 2017 Mar;29(1):31-38. doi: 10.24869/psyd.2017.31.

DOI:10.24869/psyd.2017.31

PMID:28291972

Abstract

BACKGROUND

An increasing body of research suggest that repetitive Transcranial Magnetic Stimulation (rTMS) is effective and safe treatment option for patients with major depressive disorder (MDD). The Psychiatric Hospital "Sveti Ivan" has the first TMS laboratory with rTMS and deep TMS (dTMS) in Croatia. The objective of this study was to assess the efficacy, safety and tolerability of augmentative rTMS treatment vs standard treatment in Croatian patients with major depressive disorder (MDD).

SUBJECTS AND METHODS

Total of 93 MDD patients were enrolled; 41 of them were treated by augmentative rTMS and 52 were treated by standard (psychopharmacotherapy and psychotherapy) therapy only. We delivered rTMS to the left dorsolateral prefrontal cortex at 120% motor threshold (10 Hz, 4-second train duration), 3000 pulses per session using a figure-eight coil, minimum of 20 sessions during four weeks. Our key outcome was the change in Hamilton Depression Scale (HAM-D17) result from baseline to 4 week. Our secondary outcomes were changes in Hamilton Anxiety (HAM-A) and WHOQOL-BREF scales.

RESULTS

After four weeks the changes of HAM-D17 and HAM-A results were significantly different between the group of patients treated by augmentative rTMS (48% and 53% decrease, respectively) and the group of patients treated by the standard therapy alone (24% and 30% decrease) (P=0.004, P=0.007). Absolute benefit increase defined as the difference between rates of remission (HAM-D17 ≤7) in rTMS and control group was 33% (P=0.001). Number of patients needed to treat with rTMS in order to achieve remission in one patient was NNT=3. In a group of patients treated with augmentative rTMS 21/41 (51%), and in control group 17/52 (33%) were responders (P=0.071).

CONCLUSIONS

It seems that augmentative treatment with rTMS is more effective on depression and anxiety symptoms than standard therapy in MDD with equal safety and tolerability. Randomized, controlled studies are required to verify this finding.

摘要

背景

越来越多的研究表明，重复经颅磁刺激（rTMS）是治疗重度抑郁症（MDD）患者的一种有效且安全的治疗选择。“圣伊万”精神病院拥有克罗地亚首个配备rTMS和深部经颅磁刺激（dTMS）的TMS实验室。本研究的目的是评估在克罗地亚重度抑郁症（MDD）患者中，强化rTMS治疗与标准治疗相比的疗效、安全性和耐受性。

受试者与方法

共纳入93例MDD患者；其中41例接受强化rTMS治疗，52例仅接受标准治疗（心理药物治疗和心理治疗）。我们使用八字形线圈，以120%运动阈值（10Hz，4秒脉冲串持续时间）向左侧背外侧前额叶皮层施加rTMS，每次治疗3000个脉冲，四周内至少进行20次治疗。我们的主要结局是汉密尔顿抑郁量表（HAM-D17）从基线到4周的结果变化。次要结局是汉密尔顿焦虑量表（HAM-A）和世界卫生组织生活质量简表（WHOQOL-BREF）的变化。

结果

四周后，强化rTMS治疗组（分别下降48%和53%）与仅接受标准治疗组（分别下降24%和30%）的HAM-D17和HAM-A结果变化存在显著差异（P = 0.004，P = 0.007）。绝对获益增加定义为rTMS组与对照组的缓解率（HAM-D17≤7）之差，为33%（P = 0.001）。为使1例患者达到缓解，需要接受rTMS治疗的患者数量为NNT = 3。在强化rTMS治疗组中，21/41（51%）为有效者，在对照组中，17/52（33%）为有效者（P = 0.071）。