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难治性偏头痛的外周神经刺激登记研究(RELIEF):在后枕神经刺激治疗慢性偏头痛的实际应用中观察到的疗效。

Peripheral nerve stimulation registry for intractable migraine headache (RELIEF): a real-life perspective on the utility of occipital nerve stimulation for chronic migraine.

机构信息

Department of Neurosurgery, King's College Hospital, London, UK.

Department of Neurology and Pain Management, Schmerzklinik Kiel, Kiel, Germany.

出版信息

Acta Neurochir (Wien). 2020 Dec;162(12):3201-3211. doi: 10.1007/s00701-020-04372-z. Epub 2020 May 6.

Abstract

BACKGROUND

Migraine is common and ranked as the first cause of disability in people under fifty. Despite significant advances in its pharmacological treatment, it often remains intractable. Neuromodulation is one option considered in the management of those patients.

OBJECTIVE

To assess the safety and efficacy of neuromodulation in the treatment of intractable chronic migraine using the Abbott occipital nerve stimulator.

METHODS

Recruitment took place in 18 centres in 6 countries. Patients over the age of 18 who had failed three or more preventative drugs, had at least moderate disability based on MIDAS or HIT-6 score and were implanted with an Abbott neurostimulator were included in the study. Patients were followed up for a maximum of 24 months. Data were collected on adverse events, headache relief, headache days, quality of life, migraine disability, satisfaction and quality of life.

RESULTS

One hundred twelve patients were included, 79 female and 33 male, with 45 patients reaching the maximum follow-up of 24 months. At 3 months, 33.7% were satisfied or very satisfied with the procedure with 43.0% reporting improved or greatly improved quality of life. 67.5% indicated that they would undergo the procedure again with satisfaction peaking at 9 months when 49.3% were satisfied or very satisfied with the procedure. At 24 months, 46.7% of available patients were satisfied or very satisfied with the procedure-18% of enrolled patients. The adverse events were however frequent with incidences of 37%, 47% and 31% respectively for hardware-, biological and stimulation-related side effects.

CONCLUSION

Neuromodulation can be beneficial for selected patients with intractable chronic migraine although frequent complications have been consistently reported across studies. Further research focusing on development of better hardware and technique optimisation and in particular reliable randomised trials with significantly longer follow-ups are warranted in this field.

摘要

背景

偏头痛很常见,在 50 岁以下人群中排名第一致残原因。尽管在药物治疗方面取得了重大进展,但它往往仍然难以治疗。神经调节是治疗这些患者的一种选择。

目的

使用 Abbott 枕神经刺激器评估神经调节治疗难治性慢性偏头痛的安全性和有效性。

方法

在 6 个国家的 18 个中心进行招募。纳入年龄在 18 岁以上、使用三种或三种以上预防性药物治疗失败、根据 MIDAS 或 HIT-6 评分至少有中度残疾且植入 Abbott 神经刺激器的患者。患者的随访时间最长为 24 个月。收集不良事件、头痛缓解、头痛天数、生活质量、偏头痛残疾、满意度和生活质量的数据。

结果

共纳入 112 例患者,其中女性 79 例,男性 33 例,45 例患者达到 24 个月的最大随访时间。3 个月时,33.7%的患者对该程序满意或非常满意,43.0%的患者报告生活质量改善或大大改善。67.5%的患者表示愿意再次接受该程序,9 个月时满意度最高,49.3%的患者对该程序满意或非常满意。24 个月时,46.7%的可评估患者对该程序满意或非常满意,而 18%的入组患者。然而,不良事件频繁发生,硬件、生物和刺激相关副作用的发生率分别为 37%、47%和 31%。

结论

神经调节对难治性慢性偏头痛的某些患者可能有益,但在不同研究中均报告了频繁的并发症。在这一领域,需要进一步研究,重点是开发更好的硬件和技术优化,特别是具有更长随访时间的可靠随机试验。

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