Treatment of hemicrania continua by occipital nerve stimulation with a bion device: long-term follow-up of a crossover study
Treatment of hemicrania continua by occipital nerve stimulation with a bion device: long-term follow-up of a crossover study
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DOI：
10.1016/s1474-4422(08)70217-5
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发表时间：
2008-11-01
期刊：
影响因子：
48
通讯作者：
Goadsby, Peter J.
中科院分区：
文献类型：
--
作者：
Burns, Brian;Watkins, Laurence;Goadsby, Peter J.
背景持续性偏头痛是一种以持续性单侧疼痛为主要表现的头痛，与颅脑自主神经特征有关，对吲哚美辛有反应。一些患者无法忍受这种治疗，或者这种治疗是禁忌的；对这些患者来说，治疗的医疗选择是有限的。枕神经刺激(ONS)是治疗难治性原发性头痛的有效方法，但仅有3例HC患者应用ONS治疗。在这里，我们报告了6名HC患者ONS的长期安全性和有效性数据。ONS由称为Bion的单侧神经刺激装置提供，可被描述为第二代ONS装置。方法6例18岁或以上的HC患者在其头痛的同侧植入枕下Bion装置，并接受连续的单侧ONS。采用交叉研究设计：头3个月开始使用Bion，第4个月停止，在长期随访期间再次使用Bion。植入前1个月和植入后5个月记录详细的前瞻性头痛日记。长期数据来自患者对其结果的估计。这项研究的结果是通过比较ONS前后头痛的严重程度来评估的。在中位数13.5个月(范围6-21个月)的随访中，6名患者中有5名报告了足够的益处，可以将该设备推荐给其他HC患者。在长期随访中，6名患者中有4名患者报告有实质性改善(80%-95%)，1名患者报告30%的改善，1名患者报告他的疼痛恶化20%。On S的起效时间被推迟了几天到几周，而且在设备关闭的类似时间内，头痛也没有复发。不良反应轻微，并伴有一过性过度刺激。解释ONS似乎是一种安全有效的治疗HQ的方法，特别是当吲哚美辛不耐受或不适用时。Bion装置耐受性好，很容易插入，没有明显的并发症，是目前装置体积的二十分之一。这种微型设备是治疗HC的一种潜在的新选择。
Background Hemicrania continua (HC) is a primary headache that comprises persistent unilateral pain, is associated with cranial autonomic features, and is responsive to indometacin. Some patients are unable to tolerate this treatment or it is contraindicated; for these patients, the medical options for therapy are restricted. Occipital nerve stimulation (ONS) is an effective treatment for medically intractable primary headache, but only three cases of HC treated with ONS have been reported. Here, we report long-term safety and efficacy data for ONS in six patients with HC. ONS was provided by a unilateral neurostimulation device, known as a bion, which might be described as a second-generation ONS device.Methods Six patients aged 18 years or older who were diagnosed with HC had a suboccipital bion device implanted ipsilateral to their headache and received continuous unilateral ONS. A crossover study design was used: the bion was on for the first 3 months, off for the fourth month, and on again during long-term follow-up. Detailed prospective headache diaries were kept for 1 month before implantation and for 5 months afterwards. Long-term data were obtained from patients' estimates of their outcome. The outcome of this study was assessed by a comparison of headache pain severity before and after ONS.Findings At a median follow-up of 13.5 months (range 6-21 months), five of six patients reported sufficient benefit to recommend the device to other patients with HC. At long-term follow-up, four of six patients reported a substantial improvement (80-95%), one patient reported a 30% improvement, and one patient reported that his pain was worse by 20%. The onset of the benefit of ON S was delayed by days to weeks, and headaches did not recur for a similar period when the device was switched off. Adverse events were mild and associated with transient overstimulation.Interpretation ONS appears to be a safe and effective treatment for HQ particularly when indometacin is not tolerated or is contra indicated. The bion device was well tolerated, easily inserted without significant morbidity, and is one-twentieth of the volume of current devices. Such miniaturised devices are a potential new option for treatment of HC.