在常规临床实践中对儿童使用唑尼沙胺的经验(一项多中心研究)

M. Bobylova, I. Volkov, O. Volkova, I. S. Bakhtin, D. I. Gukosyan, O. Rakhmanina, M. V. Barkhatov, I. G. Shchukina, Yu. Yu. Kalinina, K. Y. Mukhin
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引用次数: 0

摘要

背景。由于标准药物疗效不佳、不良事件和临床指南的局限性,儿童抗癫痫治疗问题仍然非常重要。评估唑尼沙胺(Zonegran)治疗癫痫儿童的疗效、耐受性和持续性。这项回顾性多中心研究在俄罗斯联邦各地区的癫痫中心进行,包括莫斯科、新西伯利亚、克拉斯诺达尔、秋明、克拉斯诺亚尔斯克、沃罗涅日、梁赞)。我们共收治了 340 名 18 岁以下患有各种癫痫综合征的患者(202 名男孩和 138 名女孩),他们都在接受唑尼沙胺治疗(平均年龄为 10.63 岁)。下列癫痫综合征患者服用了唑尼沙胺:年龄依赖性自限性儿童局灶性癫痫(n = 49;14 %)、结构性局灶性癫痫(n = 102;30 %)、伴有脑结构改变的儿童局灶性癫痫以及脑电图显示的儿童良性痫样放电(n = 38;11.2 %)、特发性全身性癫痫(n = 23;6.7 %)、发育性和癫痫性脑病(n = 44;12.9 %)(包括睡眠中出现尖波激活的发育性和癫痫性脑病(n = 23;6.7 %)、伦诺克斯-加斯托特综合征和婴儿癫痫痉挛综合征(n = 32;9.4 %)、遗传性癫痫伴全身性和局灶性发作(n = 81;23.8 %)。癫痫发作的类型分布如下:局灶运动型(205 人)、双侧强直阵挛型(192 人)、全身型(197 人),包括全身抽搐型(44 人)、强直型(70 人)、失张力型(2 人)、肌阵挛型(26 人)、癫痫痉挛型(36 人)、失神发作型(19 人)。一名患者可能有不止一种类型的癫痫发作。185 名患者的磁共振成像显示有一些变化,而 117 名患者的磁共振成像没有变化。38名患者没有进行磁共振成像,因为他们没有磁共振成像的适应症。最常见的结构性致痫变化是围产期病变的后果,表现为囊性胶质转化、萎缩(共 125 例);较少见的变化包括局灶性皮质发育不良、发育异常(如多发性小脑症、裂脑症、全脑症)、颞中叶硬化症和肿瘤。321名患者接受了Zonegran(唑尼沙胺)的额外治疗,剂量为3-8毫克/千克/天(平均剂量为5毫克/千克/天)。257名患者(75.6%)接受了Zonegran(唑尼沙胺)治疗,其中174名患者(67.7%)病情得到缓解,83名患者(32.3%)癫痫发作频率降低(50%及以上)。共有 72 名患者(21.2%)未报告任何不良反应。20名参与者(5.8%)出现了一些不良反应,其中4例在减少剂量后得到缓解,16例停止了唑尼沙胺的治疗。结论:Zonegran(唑尼沙胺)对综合治疗儿童局灶性和全身性癫痫*有效。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Experience of using zonisamide in children in routine clinical practice (a multicenter study)
Background. The problem of antiepileptic therapy in children remains highly relevant due to the insufficient efficacy of standard drugs, adverse events, and limitations of clinical guidelines.Aim. To assess the efficacy, tolerability, and continuation of zonisamide (Zonegran) therapy in children with epilepsy.Materials and methods. This retrospective multicenter study was conducted in epileptology centers in various regions of the Russian Federation, including Moscow, Novosibirsk, Krasnodar, Tyumen, Krasnoyarsk, Voronezh, Ryazan). We included 340 patients under the age of 18 (202 boys and 138 girls) with various epileptic syndromes receiving zonisamide (mean age was 10.63 years). Zonisamide was administered to patients with the following epileptic syndromes: age-dependent self-limited focal epilepsy of childhood (n = 49; 14 %) structural focal epilepsy (n = 102; 30 %), focal epilepsy of childhood with structural brain changes and benign epileptiform discharges of childhood visualized at electroencephalography (n = 38; 11.2 %), idiopathic generalized epilepsy (n = 23; 6.7 %), developmental and epileptic encephalopathies (n = 44; 12.9 %) (including developmental and epileptic encephalopathies with spike-and-wave activation during sleep (n = 23; 6.7 %)), Lennox–Gastaut syndrome and infantile epileptic spasms syndrome (n = 32; 9.4 %), genetic epilepsy with generalized and focal seizures (n = 81; 23.8 %). The type of the seizures was distributed as follows: focal motor (n = 205), bilateral tonic-clonic (n = 192), generalized (n = 197), including generalized convulsive (n = 44), tonic (n = 70), atonic (n = 2), myoclonic (n = 26), epileptic spasms (n = 36), absence seizures (n = 19). One patient could have more than one type of seizures. Magnetic resonance imaging demonstrated some changes in 185 patients, whereas 117 patients had no magnetic resonance imaging changes. Thirty-eight patients did not undergo magnetic resonance imaging as they had no indications to it. The most common structural epileptogenic changes were the consequences of perinatal lesions manifesting as cystic-gliotic transformation, atrophy (125 cases in total); less common changes included focal cortical dysplasia, developmental abnormalities (such as polymicrogyria, lissencephaly, holoprosencephaly), mesial temporal sclerosis, and tumors. Zonegran (zonisamide) as an additional therapy was administered at a dose of 3–8 mg/kg/day (mean dose 5 mg/kg/day) to 321 patients.Results. Zonegran (zonisamide) therapy was effective in 257 (75.6 %) of patients; remission was achieved in 174 patients (67.7 %), while reduced seizure frequency (50 % and greater) was registered in 83 patients (32.3 %). A total of 72 patients (21.2 %) reported no adverse events. Twenty participants (5.8 %) had some adverse events; in 4 cases, they were resolved after dosage decrease; in 16 cases, treatment with zonisamide was discontinued.Conclusion. Zonegran (zonisamide) is effective for comprehensive treatment of both focal and generalized epilepsy in children*.
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