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背景:托吡酯现已广泛应用于临床治疗各型癫痫,但对国内成年癫痫患者生活质量影响的报道较少。目的:比较传统抗癫痫药物和托吡酯对成年癫痫患者生活质量的影响,以探讨产生影响的机制。设计:采用随机对照的临床研究。地点和对象:中南大学湘雅二医院及湘雅医院门诊新诊断癫痫患者,共102例,其中男60例,女42例,年龄16～60岁。干预:102例临床新确诊的成年癫痫患者被随机分为两组:一组予以传统抗癫痫药物单药系统治疗(传统抗癫痫药物组,54例),另一组予以托吡酯单药治疗(托吡酯组,48例)。1个月后比较两组的发作频率和不良反应,并用QOLIE-30量表对这102例癫痫患者进行生活质量评定。主要观察指标:①两组发作频率和不良反应。②生活质量评分。结果:托吡酯组的发作频率和不良反应均明显低于传统抗癫痫药物组,其中前者有效11例,显效7例,控制16例;而后者有效13例,显效5例,控制13例。托吡酯组的生活质量总分却明显高于传统抗癫痫药物组,分别为60±13和53±15,尤其在前5个分项的评分中更加明显。结论:托吡酯能提高癫痫患者的生活质量,其改善生活质量的作用主要是通过控制发作和减轻不良反应实现的。
Background: Topiramate has been widely used in clinical treatment of various types of epilepsy, but few reports of the impact on the quality of life of adults with epilepsy in China. Objective: To compare the impact of traditional antiepileptic drugs and topiramate on the quality of life in adult patients with epilepsy, in order to explore the mechanism of influence. Design: Randomized controlled clinical study. Location and objects: Xiangya Hospital of Central South University and Xiangya Hospital outpatient diagnosis of epilepsy patients, a total of 102 cases, of which 60 were male and 42 females, aged 16 to 60 years. INTERVENTIONS: A total of 102 patients with newly diagnosed adult epilepsy were randomly divided into two groups: one was treated with a traditional antiepileptic drug monotherapy (traditional antiepileptic drug group, 54 patients), the other with topiramate monotherapy (topiramate Group, 48 cases). One month later, the seizure frequency and adverse reactions of the two groups were compared. The QOLIE-30 scale was used to assess the quality of life of 102 epileptic patients. MAIN OUTCOME MEASURES: ① The frequency of seizures and adverse reactions in both groups. ② quality of life score. Results: The seizure frequency and adverse reactions of topiramate group were significantly lower than those of the traditional antiepileptic group, of which the former was effective in 11 cases, markedly effective in 7 cases and control in 16 cases. The latter was effective in 13 cases, markedly effective in 5 cases and control in 13 cases. The total quality of life of topiramate group was significantly higher than the traditional antiepileptic drug group, 60 ± 13 and 53 ± 15, especially in the first five sub-items of the score more obvious. Conclusion: Topiramate can improve the quality of life in patients with epilepsy, and its effect of improving the quality of life is mainly through the control of seizures and alleviating the adverse reactions.