摘要
目的探讨托吡酯添加治疗难治性癫痫的有效性和安全性。方法对115例难治性癫痫患者应用托吡酯小剂量逐渐添加的开放性自身对照研究，第8周达最大耐受量后维持1—3年或以上。评定托吡酯的长期疗效、安全性及其与剂量的关系。结果治疗第8周、6个月、1年、2年和3年发作频率减少百分比的中位数：成人分别为56．0％、75．8％、76．1％、77．3％、78．1％，儿童分别为32．1％、66．7％、68．9％、70．1％、70．8％。部分性发作的有效率（70．6％）高于全面性发作（37．5％，P〈0．05），其中10例（11．3％）无发作〉2年。有效组维持剂量成人为（129．3±54．3）mg／d，儿童为（3．1±1．4）mg／（kg·d）。1年、2年及3年托吡酯保留率分别为72．2％、62．5％和56．1％。33例（28．7％）出现不良反应，大部分出现在加量期，最常见的为胃纳差。因不良反应退出6例（8．2％），因疗效不佳退出16例（21．9％）。结论托吡酯添加治疗难治性癫痫长期有效、安全，对部分性发作效果更佳。剂量个体化可使不良反应轻微和可耐受。
Objective To investigate the efficacy and safety of Topiramate as adjunctive therapy in patients with refractory epilepsy. Methods 115 patients enrolled in this open-label, serf-controlled prospective study which were designed to adopt slower dosage escalation schedule with lower initial, until reached target dosages （ up to 8 weeks） or the most tolerable dosages of Topiramate, and maintained them 1～3 years treatment. The long-term efficacy, safety of Topiramate and their relationship with dosage were evaluated. Results The median percentages reduction were 56.0%, 75.8%, 76. 1%, 77. 3% and 78. 1% after 8 weeks, 6 months, 1 year, 2 years and 3 years Topiramate treatment respectively for adults, and 32. 1%, 66. 7%, 68.9%, 70. 1% and 70. 8% respectively for children. The overall efficacy for partial seizures （70. 6% ） was higher than that for generalized seizures （37.5%） （P〈0.05）. Among them 10 patients （11.3%） achieved more than 2 years remission. The mean dosage in respenders was （ 129. 3 ± 54. 3 ） mg/d for adults and （ 3. 1 ± 1.4 ） mg/（ kg · d ） for children. Retention rates of Topiramate were 72. 2%, 62. 5% and 56. 1% after 1 year, 2 years and 3 years, respectively. 33 patients （28. 7% ） experienced adverse events. Most of the adverse events （ 24. 3% ） were found during titration period. The most common symptom of adverse events was anorexia （ 18. 3% ）. 6 patients （ 8. 2% ） had discontinued Topiramate for adverse events and 16 patients （ 21.9% ） for inadequate controlled. Conclusions Topiramate is showed to be effective and safe for refractory epilepsy as adjunctive therapy in this long-term study, especially for partial seizures. Adverse events may be mild and well-tolerated when titration strategy is individual.
出处
《临床神经病学杂志》
CAS
北大核心
2006年第6期463-465,共3页
Journal of Clinical Neurology
