Annegers J F, Coan S P, Hauser W A, Leestma J, Duffell W, Tarver B
The University of Texas Health Science Center Houston, School of Public Health, 77225, USA.
Epilepsia. 1998 Feb;39(2):206-12. doi: 10.1111/j.1528-1157.1998.tb01360.x.
To determine rates of all-cause mortality and of sudden, unexpected, unexplained deaths in epilepsy (SUDEP) in a cohort of individuals treated with the Neuro Cybernetic Prosthesis (NCP) System for intractable epilepsy, and; to contrast the NCP experience with other epilepsy cohorts.
A cohort of 791 individuals were followed for 1,335 person-years from implantation. Of the total cohort, 120 individuals had their NCP System devices deactivated. The 15 deaths which occurred during NCP System activation were reviewed for SUDEP by a panel. There were three additional deaths and 242.5 person-years of monitoring after deactivation.
The standardized mortality ratios for NCP System were 5.3, 95% confidence interval (CI) 3.0-8.7; and for the time period after device deactivation, 4.4, 95% CI 0.9-12.8. Six of the deaths during stimulation were considered definite or probable SUDEP and two as possible SUDEP. Seven were not considered to be SUDEP. The incidence of definite/probable SUDEP was 4.5 per 1,000 person-years and 6.0 per 1,000 person-years for definite/probable/possible SUDEP.
The mortality rates and standardized mortality ratios are comparable with studies of young adults with intractable epilepsy who were not treated with NCP System. These SUDEP rates are not significantly different from those reported in the recent studies of lamotrigine (LTG), gabapentin (GBP), and tiagabine (TGB). The higher rates of SUDEP in the NCP System cohort, as compared with recent drug trials, presumably is explained by the selection of relatively higher-risk patients for the NCP System device.
确定使用神经控制假体（NCP）系统治疗顽固性癫痫的患者队列中的全因死亡率以及癫痫猝死（SUDEP）的发生率，并将NCP的治疗经验与其他癫痫队列进行对比。
对791名患者植入后进行了1335人年的随访。在整个队列中，有120名患者的NCP系统装置被停用。一个专家小组对NCP系统激活期间发生的15例死亡病例进行了SUDEP审查。停用后又发生了3例死亡，并进行了242.5人年的监测。
NCP系统的标准化死亡率为5.3，95%置信区间（CI）为3.0 - 8.7；装置停用后的时间段内，标准化死亡率为4.4，95%CI为0.9 - 12.8。刺激期间的15例死亡中，6例被认为是明确或可能的SUDEP，2例为可能的SUDEP。7例不被认为是SUDEP。明确/可能的SUDEP发生率为每1000人年4.5例，明确/可能/可能的SUDEP发生率为每1000人年6.0例。
死亡率和标准化死亡率与未接受NCP系统治疗的顽固性癫痫青年成人研究结果相当。这些SUDEP发生率与最近关于拉莫三嗪（LTG）、加巴喷丁（GBP）和噻加宾（TGB）的研究报告的发生率没有显著差异。与最近的药物试验相比，NCP系统队列中较高的SUDEP发生率可能是由于NCP系统装置选择了相对高风险的患者。
