【摘要】 目的评价托吡酯(topiram ate)单药治疗成人及儿童癫痫患者的长期疗效和安全性。方法58例癫痫患者(成人32例,儿童26例)为新诊断癫痫(45例),或原服用1种抗癫痫药仍发作(13例)。采取托吡酯小剂量开始逐渐添加的开放性自身对照研究,第8周达最大耐受量。以后13例逐渐减原服抗癫痫药。托吡酯维持最大耐受量观察1～3年或以上。评定托吡酯的长期疗效和安全性及其与剂量的关系。结果托吡酯治疗6个月时成人组与儿童组有效率比较差异无统计学意义。治疗第8周、6个月、1年、2年和3年的有效率分别为54%、69%、74%、80%、77%,发作控制率分别为30%、39%、37%、46%、47%。部分性发作有效率(70%)与全面性发作的有效率(43%)比较差异无统计学意义(P>0.05)。连续发作控制2年以上者12例(34%)。有效组维持剂量成人为(124±55)m g/d,儿童为(2.8±1.3)m g.kg-1.d-1。第1、2、3年坚持托吡酯单药治疗者分别占73%、60%和57%。18例(31%)出现不良反应,大部分出现在添加期,最常见的不良反应为胃纳差、体重减轻和反应迟钝。观察满3年因不良反应退出2例(7%),因疗效不佳退出6例(20%)。结论托吡酯单药治疗癫痫长期有效和安全,采取个体化治疗可减轻不良反应。更多还原

【Abstract】 Objective To evaluate the long-term efficacy and safety of topiramate in monotherapy or conversion to monotherapy in patients with epilepsy. Methods Fifty-eight patients (adults:32 cases,children:26 cases) which were classified into two groups:monotherapy group (45 cases) was of newly diagnosed epilepsy;conversion monotherapy group (13 cases who had taken one antiepileptic but remained onset)enrolled in this open-labelled,self-controlled prospective study which was designed to adopt small-dosed escalation schedule of topiramate,up to its maximum tolerance dose on the 8th week.Afterwards,these 13 cases had their first-used antiepileptics decreased in dosage.Topiramate′s maximum tolerance dose for maintenance was observed for 1～3 years and over.The relation of topiramate′s long-term efficacy and safety with its dosage was also evaluated. Results No signficant difference in efficacy was showed between adults and children.Seizure frequency was reduced ≥50% in 54%,69%,74%,80% and 77% of patients after 8-week,6-month,1-year,2-year and 3-year treatment of topiramate respectively,seizure-control rates were 30%,39%,37%,46% and 47% respectively.No significant difference in efficacy was showed between partial seizures and generalized seizures.Tweleve patients(34%)had got seizure-control for more than 2 years.The mean maintenance dosage of responders was (124±55)mg/d for adults and (2.8±1.3)mg·kg-1·d-1 for children.Eighteen patients (31%) experienced adverse events (AEs).Most of the AEs (22%) were found during titration period.The most common symptom of AE was anorexia,weight loss and slow in response(7%).That topiramate monotherapy had been kept on for one,two or three years accounted for 73%,60% and 57% respectively among the patients.Three years after,2 patients (6.7%) discontinued topiramate therepy for AEs;6 patients (20%) for inadequate control. Conclusion The long-term study showed topirmate effective on epilepsy in monotherapy,both for partial and generalized seizures.AEs are mild and well-tolerated if titration strategy is individualized and depends on patients′ response.更多还原