From the Departments of Neurology (R.D., B.R., Manjari Tripathi), Neurosurgery (P.S.C.), Pediatrics (S.S., S.G.), Biostatistics (M.K., S.N.D.), Neuro-Radiology (A.G.), Nuclear Medicine (C.S.B., Madhavi Tripathi), Psychiatry (R.S.), and Pathology (C.S.), All India Institute of Medical Sciences, New Delhi, India.
N Engl J Med. 2017 Oct 26;377(17):1639-1647. doi: 10.1056/NEJMoa1615335.
Neurosurgical treatment may improve seizures in children and adolescents with drug-resistant epilepsy, but additional data are needed from randomized trials.
In this single-center trial, we randomly assigned 116 patients who were 18 years of age or younger with drug-resistant epilepsy to undergo brain surgery appropriate to the underlying cause of epilepsy along with appropriate medical therapy (surgery group, 57 patients) or to receive medical therapy alone (medical-therapy group, 59 patients). The patients in the medical-therapy group were assigned to a waiting list for surgery. The primary outcome was freedom from seizures at 12 months. Secondary outcomes were the score on the Hague Seizure Severity scale, the Binet-Kamat intelligence quotient, the social quotient on the Vineland Social Maturity Scale, and scores on the Child Behavior Checklist and the Pediatric Quality of Life Inventory.
At 12 months, freedom from seizures occurred in 44 patients (77%) in the surgery group and in 4 (7%) in the medical-therapy group (P<0.001). Between-group differences in the change from baseline to 12 months significantly favored surgery with respect to the score on the Hague Seizure Severity scale (difference, 19.4; 95% confidence interval [CI], 15.8 to 23.1; P<0.001), on the Child Behavior Checklist (difference, 13.1; 95% CI, 10.7 to 15.6; P<0.001), on the Pediatric Quality of Life Inventory (difference, 21.9; 95% CI, 16.4 to 27.6; P<0.001), and on the Vineland Social Maturity Scale (difference, 4.7; 95% CI, 0.4 to 9.1; P=0.03), but not on the Binet-Kamat intelligence quotient (difference, 2.5; 95% CI, -0.1 to 5.1; P=0.06). Serious adverse events occurred in 19 patients (33%) in the surgery group, including hemiparesis in 15 (26%).
In this single-center trial, children and adolescents with drug-resistant epilepsy who had undergone epilepsy surgery had a significantly higher rate of freedom from seizures and better scores with respect to behavior and quality of life than did those who continued medical therapy alone at 12 months. Surgery resulted in anticipated neurologic deficits related to the region of brain resection. (Funded by the Indian Council of Medical Research and others; Clinical Trial Registry-India number, CTRI/2010/091/000525 .).
神经外科治疗可能改善耐药性癫痫儿童和青少年的癫痫发作，但需要来自随机试验的更多数据。
在这项单中心试验中，我们将 116 名年龄在 18 岁或以下的耐药性癫痫患者随机分为两组：接受针对癫痫病因的脑部手术和适当的药物治疗（手术组，57 例），或仅接受药物治疗（药物治疗组，59 例）。药物治疗组的患者被分配到手术等候名单上。主要结局是 12 个月时无癫痫发作。次要结局是海牙癫痫严重程度量表评分、比奈-卡马智商、Vineland 社会成熟度量表社会商数以及儿童行为检查表和儿科生活质量量表评分。
在 12 个月时，手术组中有 44 例（77%）患者无癫痫发作，而药物治疗组中仅有 4 例（7%）患者无癫痫发作（P<0.001）。从基线到 12 个月的组间变化在海牙癫痫严重程度量表评分（差异为 19.4；95%置信区间[CI]，15.8 至 23.1；P<0.001）、儿童行为检查表（差异为 13.1；95%CI，10.7 至 15.6；P<0.001）、儿科生活质量量表（差异为 21.9；95%CI，16.4 至 27.6；P<0.001）和 Vineland 社会成熟度量表（差异为 4.7；95%CI，0.4 至 9.1；P=0.03）方面，手术组明显优于药物治疗组，但在比奈-卡马智商（差异为 2.5；95%CI，-0.1 至 5.1；P=0.06）方面无差异。手术组有 19 例（33%）患者发生严重不良事件，包括 15 例（26%）偏瘫。
在这项单中心试验中，与单独接受药物治疗的患者相比，接受癫痫手术的耐药性癫痫儿童和青少年在 12 个月时无癫痫发作的比例更高，行为和生活质量评分也更好。手术导致与脑切除区域相关的预期神经功能缺损。（由印度医学研究理事会等资助；临床试验注册印度编号，CTRI/2010/091/000525）。
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