Nahas Ziad, Marangell Lauren B, Husain Mustafa M, Rush A John, Sackeim Harold A, Lisanby Sarah H, Martinez James M, George Mark S
Brain Stimulation Laboratory, Department of Psychiatry, Medical University of South Carolina, Charleston, SC 29403, USA.
J Clin Psychiatry. 2005 Sep;66(9):1097-104. doi: 10.4088/jcp.v66n0902.
Vagus nerve stimulation (VNS) had antidepressant effects in an initial open, acute phase pilot study of 59 participants in a treatment-resistant major depressive episode (MDE). We examined the effects of adjunctive VNS over 24 months in this cohort.
Adult outpatients (N = 59) with chronic or recurrent major depressive disorder or bipolar (I or II) disorder and experiencing a treatment-resistant, nonpsychotic MDE (DSM-IV criteria) received 2 years of VNS. Changes in psychotropic medications and VNS stimulus parameters were allowed only after the first 3 months. Response was defined as > or = 50% reduction from the baseline 28-item Hamilton Rating Scale for Depression (HAM-D-28) total score, and remission was defined as a HAM-D-28 score < or = 10.
Based on last observation carried forward analyses, HAM-D-28 response rates were 31% (18/59) after 3 months, 44% (26/59) after 1 year, and 42% (25/59) after 2 years of adjunctive VNS. Remission rates were 15% (9/59) at 3 months, 27% (16/59) at 1 year, and 22% (13/59) at 2 years. By 2 years, 2 deaths (unrelated to VNS) had occurred, 4 participants had withdrawn from the study, and 81% (48/59) were still receiving VNS. Longer-term VNS was generally well tolerated.
These results suggest that patients with chronic or recurrent, treatment-resistant depression may show long-term benefit when treated with VNS.
在一项针对59名难治性重度抑郁发作（MDE）患者的初始开放性急性期试点研究中，迷走神经刺激（VNS）显示出抗抑郁作用。我们在该队列中研究了辅助性VNS在24个月内的效果。
患有慢性或复发性重度抑郁症或双相（I型或II型）障碍且经历难治性、非精神病性MDE（符合《精神疾病诊断与统计手册》第四版标准）的成年门诊患者（N = 59）接受了2年的VNS治疗。仅在最初3个月后允许调整精神药物和VNS刺激参数。缓解定义为28项汉密尔顿抑郁评定量表（HAM-D-28）总分较基线降低≥50%，痊愈定义为HAM-D-28评分≤10。
基于末次观察向前结转分析，辅助性VNS治疗3个月后，HAM-D-28缓解率为31%（18/59），1年后为44%（26/59），2年后为42%（25/59）。痊愈率在3个月时为15%（9/59），1年时为27%（16/59），2年时为22%（13/59）。到2年时，发生了2例死亡（与VNS无关），4名参与者退出研究，81%（48/59）仍在接受VNS治疗。长期VNS治疗总体耐受性良好。
这些结果表明，慢性或复发性难治性抑郁症患者接受VNS治疗可能会有长期益处。
