FDA批准神经刺激器用于难治性癫痫治疗

11月14日，美国食品药品管理局(FDA)宣布，基于191例患者3个月的研究结果，已批准一款植入式神经刺激器用于药物难治性癫痫患者的治疗。

据该RNS刺激器制造商Neuropace公司称，刺激器被植入颅骨后，与埋在癫痫病灶附近的1~2根导线相连接，可监测脑部异常电活动，并通过释放微弱的电刺激，使脑部电活动在患者发作之前正常化。


RNS刺激器     

FDA声明指出，在对191例患者的研究中，装置开启后每月发作次数平均下降38%，而装置关闭后平均下降17%。3个月时，装置开启后发作次数中位下降34%，而装置关闭后为19%。数据还表明，在为期2年的非盲法随访期间，发作频次呈持续下降。

最常见不良反应为植入部位感染和过早电池耗竭。

FDA声称，RNS刺激器植入者不应接受磁共振影像检查、透热治疗、电惊厥治疗或经颅磁刺激治疗，因为这些治疗可导致电池过早耗竭，甚至装置关闭。

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By: ELIZABETH MECHCATIE, Internal Medicine News Digital Network

An implantable neurostimulator has been approved as a treatment for people with medically intractable epilepsy, based on a 3-month study of 191 patients, the Food and Drug Administration announced on Nov. 14.

The RNS stimulator, manufactured by Neuropace, is implanted in the cranium and is connected to 1-2 leads implanted near the seizure focus. It is designed "to detect abnormal electrical activity in the brain and respond by delivering imperceptible levels of electrical stimulation to normalize brain activity before an individual experiences seizures," according to Neuropace.

In the study of 191 patients, the number of seizures per month dropped by an average of 38% when the device was turned on, compared with an average 17% drop when the device was turned off, the FDA said in the statement announcing the approval. At the end of 3 months, seizures had been reduced by a median of 34% when the device was turned on, compared with a median 19% reduction when it was turned off. During a 2-year follow-up unblinded phase of the study, "data demonstrated a persistent reduction in seizure frequency," according to the FDA announcement.

The most common adverse effects of treatment were infections at the implant site and premature battery depletion, the agency said.

Patients who have RNS stimulators should not undergo magnetic resonance imaging, diathermy procedures, electroconvulsive therapy, or transcranial magnetic stimulation, which can cause permanent brain damage, even when the device is turned off, the FDA statement said.