左乙拉西坦添加治疗儿童难治性癫痫部分性发作的临床研究

发布时间：2018-02-27 07:54

本文关键词： 左乙拉西坦添加治疗难治性癫痫儿童　出处：《山西医科大学》2012年硕士论文　论文类型：学位论文

【摘要】：目的：评价左乙拉西坦(Levetiratam,LEV)作为添加剂治疗儿童难治性癫痫部分性发作的疗效和安全性。方法：采用开放性自身对照研究,收集2009年6月-2011年6月山西省儿童医院神经内科门诊及住院确诊的难治性癫痫部分性发作患儿72例(男40例,女32例,年龄7月～15岁)为研究对象,治疗随访6-24月,观察治疗疗效及不良反应的发生情况。结果： ①左乙拉西坦(Levetiratam,LEV)作为添加剂治疗儿童难治性癫痫部分性发作达到完全控制8例(8/68),占11.8%,有效25例(25/68),占36.7%,总有效率达48.5%。治疗前后癫痫发作次数比较,二者差异有统计学意义(P0.05)。 ②LEV添加治疗简单部分性发作总有效率54.5%,复杂部分性发作总有效率46.4%,部分性发作继发全面性发作总有效率48.3%三组比较差异无统计学意义(P0.05); LEV添加治疗(?)4岁年龄组总有效率48.6%,4岁年龄组总有效率48.4%,两组比较差异无统计学意义(p0.05); LEV添加治疗病程(?)3年患儿总有效率50.0%,病程3年患儿总有效率46.7%,两组比较差异无统计学意义(P0.05); LEV添加治疗头颅影像学有异常患儿总有效率47.2%,无异常患儿总有效率50.0%,两组比较差异无统计学意义(P0.05)。 ③LEV添加治疗3、6、12和24个月无发作率分别为8.8%、14.7%、11.8%和11.8%,治疗6个月、12个月和24个月与3个月总有效率比较均无统计学意义(P0.05)。 ④LEV添加治疗的有效剂量为10-60mg/(kg.d),平均有效剂量为37mg/(kg.d) ⑤LEV添加治疗不良反应发生率为33.8%,其中11例情绪异常(攻击行为、脾气暴躁、摔东西)(16.1%),6例乏力、睡眠多(8.8%)；4例兴奋、语言多、睡眠时间减少(5.9%)；皮疹1例(1.5%)；腹泻1例(1.5%)。减量或在2-4周后自然消失。未导致停药。未发现过敏及血液系统,肝肾功能异常等不良反应。 ⑥LEV添加治疗3、6、12和24个月保留率为94.1%、51、5%、45.6%和44.1%。结论：LEV添加治疗儿童难治性癫痫部分性发作有确切的疗效,患儿发作类型、年龄、病程、头颅影像学有无异常对其疗效影响不大,LEV长期治疗效果稳定,有良好的安全性,保留率较高,可在临床进一步推广使用。
[Abstract]:Objective: to evaluate the efficacy and safety of Levetiratamme Levetiratamlov as an additive in the treatment of intractable partial seizure in children. Methods: from June 2009 to June 2011, 72 children (40 males and 32 females) with refractory partial epileptic seizures diagnosed in Department of Neurology, Department of Neurology, Shanxi Children's Hospital, were collected by an open self-control study. Age from July to 15 years old). Follow up for 6-24 months to observe the curative effect and the occurrence of adverse reactions. Results:. (1) Levetiratamme Levetiratammov (Levetiratammov) as an additive in the treatment of intractable partial seizures in children achieved complete control (8 / 68), accounting for 11.8%, effective 25 / 68 (36.7%), and the total effective rate was 48.5%. There was a statistically significant difference between the two groups in the number of epileptic seizures before and after treatment (P0.05). 2The total effective rate of simple partial attack was 54.5%, the total effective rate of complex partial attack was 46.4%, the total effective rate of partial secondary comprehensive attack was 48.3%, there was no significant difference among three groups (P 0.05). The total effective rate of the 4-year-old group was 48.6% and the total effective rate of the 4-year-old group was 48.4%, the difference between the two groups was not statistically significant (p 0.05). ) the total effective rate was 50.0% in 3 years and 46.7% in course of disease. There was no significant difference between the two groups (P 0.05), and the total effective rate of LEV plus therapy was 47.2% and 50.0% in children with abnormal cranial imaging. There was no significant difference between the two groups (P 0.05). The rates of no attack at 12 and 24 months after treatment with 3 LEV were 8. 8% and 11. 8%, respectively. There was no significant difference in the total effective rate between 6 months, 12 months and 24 months and 3 months after treatment (P 0. 05%). 4 the effective dose of LEV plus therapy is 10-60 mg / r / kg 路dL, and the average effective dose is 37 mg / r / kg 路d). (5) the incidence of adverse effects of LEV supplementation was 33.8. Among them, 11 cases had abnormal mood (aggressive behavior, grumpy temper, 6 cases of fatigue, 8. 8% sleep and 8. 8%), and 4 cases were excitatory and verbal. Sleep time was decreased by 5.9%; rash in 1 case was involved in 1 case; diarrhea in 1 case was reduced or disappeared naturally after 2-4 weeks. No side effects such as allergies, blood system, abnormal liver and kidney function were found. The retention rates of 6LEV for 12 and 24 months were 94.1% and 44.1%, 45.6% and 44.1%, respectively. Conclusion the effect of the addition of Lev on refractory partial seizure in children is definite. The type of attack, age, course of disease, and abnormal brain imaging have little effect on the long-term therapeutic effect of Lev, and it has good safety. The retention rate is high and can be further popularized in clinic.
【学位授予单位】：山西医科大学
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：R742.1

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