皮层刺激设备可安全、持续减少癫痫发作

华盛顿——对大量药物难治性部分性发作癫痫患者的长期疗效和安全性研究显示，一种可提供反应性皮层刺激的设备可安全、持续减少癫痫发作。这种被称为RNS系统（NeuroPace公司）的设备已于2013年11月份获得美国食品药品管理局(FDA)批准用于成年患者。



最初的65例患者是在较早的一项为期2年的可行性研究中植入RNS系统，另外191例患者是在一项为期2年的多中心、双盲、随机、假治疗对照的关键研究中植入RNS系统。受试者平均年龄为34岁，平均癫痫病程为19.6年，正在使用抗癫痫药物平均为2.9种。约翰霍普金斯癫痫中心主任Bergey医生在美国癫痫学会年会上介绍，癫痫局限于1~2处致痫灶，中位癫痫发作频率为每28天10.2次。研究人群治疗极度困难，每月发生至少3次致残性癫痫，没有1个月的致残性癫痫发作次数低于2次。



研究显示，对于成年部分性癫痫发作患者，RNS系统作为一种辅助治疗是安全和有效的。对这256例成年患者的研究中发现，这种设备使用1年和2年时，分别使癫痫发作频率中位数降低38.9%和51.1%；20%的患者持续无癫痫发作达至少6个月。在截至2012年11月1日的中位4.5年随访期间，未发现任何安全性问题。在当前的长期疗效和安全性研究中，未发生任何预期之外的设备相关严重不良事件，并且总的设备相关不良事件发生率随使用时间延长而降低。出血和感染相关事件的严重不良事件发生率分别为每植入年0.010和0.023起。多数此类不良事件发生于植入后第一年内。研究期间发生的11例死亡中，2例与自杀有关，1例的死因为与癫痫持续状态相关的并发症，1例死于淋巴瘤，7例的死因为癫痫患者突发意外死亡（包括未接受反应性刺激患者中发生的2例死亡），死亡率为2.5例/1,000患者刺激年。

Bergey医生总结道，难治性部分性发作癫痫患者可选择这种新型治疗，并补充指出，当前研究结果显示，随着使用时间延长，病情呈进行性改善，支持RNS系统的长期安全性和有效性。

Bergey医生披露无相关利益冲突。

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By: SHARON WORCESTER, Internal Medicine News Digital Network

WASHINGTON – A recently approved device that provides responsive cortical stimulation was safe and provided sustained seizure reduction for a substantial number of patients with medically intractable partial onset seizures in a long-term efficacy and safety study.

The device – the RNS system (NeuroPace Inc.), which received Food and Drug Administration approval in November for use in adults – was associated with a median reduction in seizure frequency of 38.9% at 1 year and 51.1% at 2 years in 256 adult patients; 20% of patients were free of seizures for at least 6 months. No safety issues arose over a median of 4.5 years of follow-up (1,200 patient implant-years) as of Nov. 1, 2012, Dr. Gregory K. Bergey reported at the annual meeting of the American Epilepsy Society.
 
Study subjects had a mean age of 34 years and a mean epilepsy duration of 19.6 years. They were taking a mean of 2.9 antiepileptic drugs. Their seizures were localized to one or two seizure foci, and their median seizure frequency was 10.2 per 28 days, said Dr. Bergey, director of the Johns Hopkins Epilepsy Center in Baltimore.

The study population was extremely refractory, experiencing at least three debilitating seizures monthly and having no months with fewer than two such seizures, he noted.

The first 65 patients were implanted during an earlier 2-year feasibility study, and 191 additional patients were implanted during a 2-year, multicenter, double-blind, randomized, sham-controlled, pivotal study in which the RNS system was also found to be safe and effective as an adjunct treatment for adults with partial-onset seizures.

In the current long-term efficacy and safety study, no unanticipated device-related serious adverse events occurred, and the overall rate of device-related adverse events declined over time. The serious adverse event rate was 0.010 per implant-year for hemorrhage-related events, and 0.023 per implant-year for infection-related events. Most of these events occurred in the first year after implant.

Of 11 deaths that occurred during the study period, 2 involved suicide, 1 occurred because of complications associated with status epilepticus, 1 was because of lymphoma, and 7 were attributed to sudden unexpected death in epilepsy (including 2 among patients not being treated with responsive stimulation) for a rate of 2.5/1,000 patient stimulation-years.

"This new treatment is an option for patients with intractable partial seizures," Dr. Bergey concluded, adding that the current findings, which show progressive improvement over time, support the long-term safety and efficacy of the RNS system.

A 7-year, open-label phase of the study is ongoing to accumulate 9 years of prospective data for those implanted during the feasibility and pivotal studies.

Dr. Bergey reported having no disclosures.