Schlaepfer T E, Frick C, Zobel A, Maier W, Heuser I, Bajbouj M, O'Keane V, Corcoran C, Adolfsson R, Trimble M, Rau H, Hoff H-J, Padberg F, Müller-Siecheneder F, Audenaert K, Van den Abbeele D, Stanga Z, Hasdemir M
Departments of Psychiatry, University Hospital, Bern, Switzerland.
Psychol Med. 2008 May;38(5):651-61. doi: 10.1017/S0033291707001924. Epub 2008 Jan 4.
Vagus nerve stimulation (VNS) therapy is associated with a decrease in seizure frequency in partial-onset seizure patients. Initial trials suggest that it may be an effective treatment, with few side-effects, for intractable depression.
An open, uncontrolled European multi-centre study (D03) of VNS therapy was conducted, in addition to stable pharmacotherapy, in 74 patients with treatment-resistant depression (TRD). Treatment remained unchanged for the first 3 months; in the subsequent 9 months, medications and VNS dosing parameters were altered as indicated clinically.
The baseline 28-item Hamilton Depression Rating Scale (HAMD-28) score averaged 34. After 3 months of VNS, response rates (> or = 50% reduction in baseline scores) reached 37% and remission rates (HAMD-28 score <10) 17%. Response rates increased to 53% after 1 year of VNS, and remission rates reached 33%. Response was defined as sustained if no relapse occurred during the first year of VNS after response onset; 44% of patients met these criteria. Median time to response was 9 months. Most frequent side-effects were voice alteration (63% at 3 months of stimulation) and coughing (23%).
VNS therapy was effective in reducing severity of depression; efficacy increased over time. Efficacy ratings were in the same range as those previously reported from a USA study using a similar protocol; at 12 months, reduction of symptom severity was significantly higher in the European sample. This might be explained by a small but significant difference in the baseline HAMD-28 score and the lower number of treatments in the current episode in the European study.
迷走神经刺激（VNS）疗法与部分发作性癫痫患者的癫痫发作频率降低有关。初步试验表明，对于难治性抑郁症，它可能是一种有效的治疗方法，且副作用较少。
除稳定的药物治疗外，对74例难治性抑郁症（TRD）患者进行了一项开放性、非对照的欧洲多中心VNS疗法研究（D03）。在最初3个月治疗保持不变；在随后的9个月中，根据临床情况改变药物和VNS给药参数。
基线时28项汉密尔顿抑郁量表（HAMD - 28）评分平均为34分。VNS治疗3个月后，有效率（基线评分降低≥50%）达到37%，缓解率（HAMD - 28评分＜10）为17%。VNS治疗1年后有效率增至53%，缓解率达到33%。如果在VNS治疗的第一年出现反应后无复发，则将反应定义为持续；44%的患者符合这些标准。反应的中位时间为9个月。最常见的副作用是声音改变（刺激3个月时为63%）和咳嗽（23%）。
VNS疗法可有效减轻抑郁严重程度；疗效随时间增加。疗效评级与之前美国一项采用类似方案的研究报告的范围相同；在12个月时，欧洲样本中症状严重程度的降低明显更高。这可能是由于欧洲研究中基线HAMD - 28评分存在小但显著的差异以及当前发作中治疗次数较少所致。
