Safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase I/II proof of concept trial.
Safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase I/II proof of concept trial.
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DOI：
10.1111/j.1526-4637.2011.01203.x
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发表时间：
2011-09
期刊：
影响因子：
--
通讯作者：
Natelson BH
中科院分区：
文献类型：
--
作者：
Lange G;Janal MN;Maniker A;Fitzgibbons J;Fobler M;Cook D;Natelson BH
我们进行了一项开放标签I/II期试验，以评估迷走神经刺激（VNS）治疗难治性纤维肌痛（FM）患者的安全性和耐受性，并确定这些患者的初步疗效指标。在植入VNS刺激器的14例患者中，12例完成了最初3个月的VNS研究；11人在刺激开始后5、8和11个月返回进行随访。治疗效果通过疼痛、整体健康和身体功能改善的综合指标进行评估。由于在3个月的刺激结束时发现的结果，因此增加了诊断FM的疼痛和压痛标准的丧失作为次要结果测量。副作用与用VNS治疗癫痫或抑郁症的患者相似，此外，据报道，口干和疲劳。2例患者不能耐受刺激。3个月时，5名参与者达到了疗效标准；其中，2例不再符合诊断FM的普遍疼痛或压痛标准。治疗效果似乎随着时间的推移而增加，因为额外的参与者在11个月时达到了两个标准。副作用和耐受性与目前用VNS治疗的疾病相似。初步的结果测量表明，VNS可能是一种有用的辅助治疗，对FM患者抵抗传统的治疗管理，但需要进一步的研究，以更好地了解其在FM治疗中的实际作用。
We performed an open label Phase I/II trial to evaluate the safety and tolerability of vagus nerve stimulation (VNS) in patients with treatment-resistant fibromyalgia (FM) as well as to determine preliminary measures of efficacy in these patients. Of 14 patients implanted with the VNS stimulator, 12 completed the initial 3 month study of VNS; 11 returned for follow-up visits 5, 8 and 11 months after start of stimulation. Therapeutic efficacy was assessed with a composite measure requiring improvement in pain, overall wellness, and physical function. Loss of both pain and tenderness criteria for the diagnosis of FM was added as a secondary outcome measure because of results found at the end of 3 months of stimulation. Side effects were similar to those reported in patients treated with VNS for epilepsy or depression and, in addition, dry mouth and fatigue were reported. Two patients did not tolerate stimulation. At 3 months, five participants had attained efficacy criteria; of these, two no longer met widespread pain or tenderness criteria for the diagnosis of FM. The therapeutic effect seemed to increase over time in that additional participants attained both criteria at 11 months. Side effects and tolerability were similar to those found in disorders currently treated with VNS. Preliminary outcome measures suggested that VNS may be a useful adjunct treatment for FM patients resistant to conventional therapeutic management but further research is required to better understand its actual role in the treatment of FM.
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5.3
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