摘要
目的 探讨国产闭环自响应神经刺激系统在药物难治性癫痫治疗中的初期疗效.方法 前瞻性纳入2022年3-11月浙江大学医学院附属第二医院神经外科收治的6例药物难治性癫痫患者,给予闭环自响应神经刺激系统治疗.开机后4、7、10、13个月于门诊随访评估治疗的有效性和安全性,包括癫痫控制效果、生活质量改善情况及不良反应发生情况,其中癫痫控制效果根据发作频率、时长、每月发作日数量的减少率等指标进行评价.结果 6例患者的手术均顺利完成.4例患者于双侧海马植入深部电极(2根/例),1例于左侧中央区植入2根皮质电极,1例于左侧海马+左侧颞叶植入深部电极、皮质电极各1根.刺激参数的中位数:电流强度为4.0 mA,频率为200 Hz,脉宽为160μs,持续时间为100 ms.开机后5例完成13个月的随访,1例仅完成11个月随访.开机后10个月和13个月随访时,患者的癫痫发作频率分别较术前基线下降[M(Q1,Q3)]39%(10%,46%)和44%(21%,49%).至末次随访,4例患者的癫痫发作时长减少≤10%,2例减少>30%;4例每月发作日数量减少≤10%,2例减少>30%.与术前基线比较,开机7个月后患者的汉密尔顿抑郁量表、生活质量量表31、汉密尔顿焦虑量表以及蒙特利尔认知评估量表评分的差异均无统计学意义(均P>0.05).至末次随访,所有患者均未发生手术或器械相关不良事件.结论 初步观察发现,采用国产闭环自响应神经刺激系统治疗可在一定程度上减少药物难治性癫痫患者的癫痫发作频率,且未观察到相关不良事件.
ObjectiveTo explore the initial efficacy of the domestic closed-loop self-responsive neurostimulation system in the treatment of drug-resistant epilepsy.MethodsSix patients with refractory epilepsy admitted to the Neurosurgery Department of the Second Affiliated Hospital of Zhejiang University School of Medicine from March 2022 to November 2022 were prospectively enrolled and treated with a closed-loop self-responsive neurostimulation system.The effectiveness and safety of the treatment were evaluated in the outpatient clinic 4,7,10,and 13 months after the start of the stimulation,including the seizure control effect,improvement in quality of life,and occurrence of adverse reactions.The seizure control effect was assessed based on the frequency,duration,and number of days with the seizures in a month.ResultsThe operations of all 6 patients were successfully completed.Among them,4 patients were implanted with deep electrodes(2 per case)in the bilateral hippocampi,1 patient was implanted with 2 cortical electrodes in the left central cortex,and 1 patient was implanted with 1 deep electrode and 1 cortical electrodes in the left hippocampus+left temporal lobe respectively.Stimulation parameters(median)included the amplitude of 4.0 mA,frequency of 200 Hz,pulse width of 160μs and duration of 100 ms.Five cases completed the 13-month follow-up after startup,and one case only completed the 11-month follow-up.At 10 months and 13 months follow-up after the device was turned on,the patient′s seizure frequency decreased[M(Q 1,Q 3)]by 39%(10%,46%)and 44%(21%,49%)respectively compared with the preoperative baseline.By the last follow-up,the duration of epileptic seizures was reduced by≤10%in 4 patients and by>30%in 2 patients;the number of seizure days was reduced by≤10%in 4 patients and by>30%in 2 patients.Compared with the preoperative baseline,there were no statistically significant differences in the patients′Hamilton Depression Rating Scale,Quality of Life Scale 31,Hamilton Anxiety Rating Scale or Montreal Cognitive Assessment scores 7 months after the start of stimulation(all P>0.05).As of the last follow-up,no surgery-or device-related adverse events occurred in any patient.ConclusionPreliminary observations indicate that treatment with a domestic closed-loop self-responsive neurostimulation system can reduce the frequency of epileptic seizures in patients with refractory epilepsy to a certain extent,and no related adverse events have been observed.
作者
蒋鸿杰
张啸涛
郑喆
吴承瀚
朱周乐
张建民
朱君明
Jiang Hongjie;Zhang Xiaotao;Zheng Zhe;Wu Chenghan;Zhu Zhoule;Zhang Jianmin;Zhu Junming(Department of Neurosurgery,the Second Affiliated Hospital of Zhejiang University School of Medicine,Clinical Research Center of Neurological Disease of Zhejiang Province,Hangzhou 310009,China)
出处
《中华神经外科杂志》
CSCD
北大核心
2024年第2期143-147,共5页
Chinese Journal of Neurosurgery
基金
科技部科技创新2030重大项目(2021ZD0200404)。
关键词
耐药性癫痫
电刺激疗法
治疗结果
闭环神经刺激
Drug resistant epilepsy
Electric stimulation therapy
Treatment outcome
Closed-loop neurostimulation
