Advanced Interventions Service, NHS Tayside, Ninewells Hospital and Medical School, Dundee DD1 9SY, UK.
J Affect Disord. 2013 Sep 25;150(3):1221-5. doi: 10.1016/j.jad.2013.05.080. Epub 2013 Jun 29.
There are limited treatment options for patients with chronic, treatment-refractory major depression who do not respond to routinely-available treatments. Vagus Nerve Stimulation (VNS) may represent an alternative to ablative neurosurgery for a specific group of patients.
12-month response rates for 28 patients with chronic (≥2 years) major depression who had failed to respond to ≥4 adequate treatment trials in the D03 European open clinical trial of VNS were described along with response rates for 13 consecutive patients who underwent VNS within the neurosurgical treatment programme in Dundee.
In the D03 cohort (N=28), the response rate at 12 months (defined as a 50% reduction in symptom score) was 35.7%. In the Dundee VNS case series (N=13), the equivalent response rate was 30.8%.
These data are from unblinded and open studies, and there is no control group. Other factors may have contributed to some of the improvement seen, although this is unlikely in very chronic populations. Outcomes are not reported beyond 12 months.
Response rates at 12 months for patients with chronic and highly-refractory major depression are broadly consistent with previously published results in more heterogeneous and less refractory clinical trial populations. In highly treatment-resistant patients, the rate of response with VNS at 12 m is at least twice that anticipated with 'treatment-as-usual'.
对于那些对常规治疗方法无反应的慢性、治疗难治性重度抑郁症患者，治疗选择有限。迷走神经刺激（VNS）可能是一种替代消融性神经外科手术的方法，适用于特定的患者群体。
描述了 28 名慢性（≥2 年）重度抑郁症患者在 D03 欧洲 VNS 开放性临床试验中接受≥4 种充分治疗试验后无反应的 12 个月应答率，以及在邓迪神经外科治疗计划中接受 VNS 的 13 例连续患者的应答率。
在 D03 队列（N=28）中，12 个月的应答率（定义为症状评分降低 50%）为 35.7%。在邓迪 VNS 病例系列研究（N=13）中，等效的应答率为 30.8%。
这些数据来自于非盲和开放性研究，没有对照组。尽管在非常慢性的人群中不太可能，但其他因素可能导致了部分改善。结果未报告超过 12 个月。
对于慢性和高度难治性重度抑郁症患者，12 个月的应答率与先前在更具异质性和较少难治性临床试验人群中发表的结果大致一致。在高度治疗抵抗的患者中，VNS 在 12 个月时的反应率至少是“常规治疗”预期的两倍。
