左乙拉西坦治疗成人癫痫的临床疗效及安全性

发布时间：2018-04-22 21:06

本文选题：癫痫 + 左乙拉西坦　；参考：《苏州大学》2014年硕士论文

【摘要】：目的左乙拉西坦（Levetiracetam，LEV）是一种新型抗癫痫药物（AEDs），有独特的抗癫痫作用机制。1999年本品获美国FDA批准，用于成人部分性癫痫发作的添加治疗，2005年欧盟批准左乙拉西坦单药治疗癫痫部分性发作伴或不伴继发性全面性发作的16岁以上新诊断的癫痫。2007年3月在我国批准上市，适用于成人及4岁以上儿童癫痫患者部分性发作的添加治疗。本文主要研究左乙拉西坦(LEV)添加和单药治疗成人癫痫的临床疗效及安全性。方法共有147例成人癫痫患者纳入本研究，其中102例为既往诊断明确的癫痫患者，并正在服用1种或1种以上一线抗癫痫药物，未能完全控制，予LEV添加治疗。45例为新诊断的未经治疗的各类型成人癫痫患者，予LEV单药治疗。并进行24周开放性自身对照随访研究，观察治疗的有效性及安全性。结果治疗24周后，LEV添加治疗患者癫痫发作完全控制率19.6％，总有效率79.4％；单纯部分性发作组中，完全控制4例（15.4％），显效12例（46.2％），有效5例（19.2％），无效5例（19.2％）；复杂部分性发作组中，完全控制5例（17.9％），显效10例（35.7％），有效9例（32.1％），无效4例（14.3％）；部分继发全面性发作组中，完全控制8例（25.8％），显效9例（29％），有效6例（19.4％），无效8例（25.8％），全面性发作组中，完全控制3例（17.6％），，显效6例（35.3％），有效4例（23.5％），无效4例（23.5％）。4组疗效比较差异无统计学意义。45例LEV单药治疗患者癫痫发作完全控制率20.0％,总有效率86.7%。部分性发作组中，完全控制5例(23.8％)，显效7例（33.3％），有效6例(28.6％)，无效2例(9.5％)，加重1例(4.8％)；全面性发作组例中，完全控制4例(16.7％)，显效9例（37.5％），有效8例(33.3％)，无效2例(8.3％)，加重1例(4.2％)。2组疗效比较差异无统计学意义。使用左乙拉西坦治疗6-12个月后均复查脑电图，12例(8.2％)患者痫性放电消失，71例(48.3％)脑电图痫性放电减少大于50％，64例(43.5％)脑电图改善不明显，无脑电图加重者，缓解率占56.5％。左乙拉西坦治疗期间26.5％(39/147)患者出现不良反应。不良反应主要有嗜睡乏力、头晕、恶心呕吐、食欲下降等，未予特殊处理，2-8周后自行缓解，没有病例因严重不良反应而退出。结论 1.左乙拉西坦添加和单药治疗对各种发作类型的成人癫痫均有疗效。 2.左乙拉西坦添加和单药治疗成人癫痫脑电图痫性放电减少大于50%。 3.左乙拉西坦添加和单药治疗成人癫痫不良反应发生率低，持续时间短，并均为可耐受程度。
[Abstract]:objective
Levetiracetam (LEV) is a new type of antiepileptic drug (AEDs), which has a unique anti epileptic mechanism for.1999 year. This product was approved by the United States FDA for adult partial epileptic seizures. In 2005, the European Union approved levetiracetam for the treatment of partial seizures with or without secondary total seizures at 16 years of age. The newly diagnosed epilepsy was approved in China in March.2007, which is suitable for the treatment of partial seizures in adults and children over 4 years of age. This paper mainly studies the clinical efficacy and safety of LEV addition and single drug treatment for adult epilepsy.
Method
A total of 147 adult epileptic patients were included in this study, of which 102 were diagnosed as previously diagnosed epileptic patients and were taking 1 or more than 1 first-line antiepileptic drugs and failed to complete control. LEV was added to.45 as a newly diagnosed type of untreated adult epileptic patients, given LEV single drug treatment and 24 weeks open self. Follow up study was conducted to observe the efficacy and safety of the treatment.
Result
After 24 weeks of treatment, the total control rate of epileptic seizures in LEV patients was 19.6%, the total effective rate was 79.4%, 4 cases (15.4%), 12 cases (46.2%), 5 cases (19.2%), and 5 cases (19.2%) in the simple partial seizure group. 1%), 4 cases (14.3%) were ineffective, 8 cases (25.8%), 9 cases (29%), 6 cases (19.4%), 8 cases (25.8%), totally controlled 3 cases (17.6%) in the total seizure group, and there was no significant difference in the curative effect of the.4 group with no statistical significance.45 The total control rate of epileptic seizures in patients with LEV was 20%. In the total effective 86.7%. partial seizure group, 5 cases (23.8%) were completely controlled, 7 cases (33.3%), 6 cases (28.6%), 2 cases (9.5%), and 1 cases (4.8%). Effective 2 cases (8.3%), aggravated 1 cases (4.2%).2 group curative effect comparison difference has no statistically significant difference. The use of Zuo Yi Lacita treatment 6-12 months after the reexamination of electroencephalogram, 12 cases (8.2%) of epileptic discharge disappeared, 71 cases (48.3%) electroencephalogram epileptic discharge decreased more than 50%, 64 cases (43.5%) electroencephalogram improvement is not obvious, no electroencephalograph aggravation, remission rate 26.5% (39/147) patients had adverse reactions during the treatment of 56.5%. levetiracetam. The main adverse reactions were lethargy, dizziness, nausea and vomiting, loss of appetite and so on. No special treatment was given. After 2-8 weeks, no cases were withdrawn from serious adverse reactions.
conclusion
1. levetiracetam plus monotherapy is effective in treating adult epilepsy with various seizures.
2. the incidence of epileptic discharge in adult epilepsy with levetiracetam added and monotherapy decreased more than 50%.
3. levetiracetam plus and monotherapy had a low incidence of ADR in adults, with short duration and tolerability.

【学位授予单位】：苏州大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R742.1

【参考文献】