托吡酯多中心开放性治疗老年癫痫的临床观察

Monotherapy or add-on therapy with topiramate in elderly patients with epilepsy： results of an open-label multicenter trial

目的研究单用或加用托吡酯治疗老年癫痫患者的疗效和不良事件。方法在一项托吡酯治疗癫痫的多中心开放实验中，对全国52家医院门诊病例的119例60岁以上的老年癫痫患者疗效进行分析．剂量采用8周加量期到200mg／d，接着是12周的稳定期，治疗期间每月随访一次。结果稳定期结束后，119例患者中有106例（89．1％）发作减少超过50％。119例患者中65例单用托吡酯治疗，有效率为93．8％，54例合并用药，有效率为83．8％。各种类型癫痫患者单用或加用托吡酯治疗后，发作完全控制的患者的例数均超过50％。单用或加用托吡酯治疗病程分别为小于1年、1～3年、4-6年、大于6年的患者的发作减少频数分别为92．86％、91．67％、100％、94．44％和80．00％、85．71％、70．00％、86．36％。合并用卡马西平、丙戊酸钠、苯妥英钠、苯巴比妥、安定的患者总有效率分别为：79．41％、87．50％、85．71％、0％、80％。单用托吡酯治疗老年患者副作用程度较轻。结论托吡酯无论单用或加用治疗老年癫痫患者，在稳定期结束后发作次数均明显减少，单用副作用程度较轻。不同的发作类型、基础病程、加用药物对疗效无明显影响。

Objective To assess the efficacy and adverse-event profile of monotherapy or add-on therapy with topiramate in elderly patients with epilepsy. Methods A multicenter, prospective, open-label, observational study of topiramate, for either monotherapy or add-on therapy, was performed among 119 elderly patients with epilepsy in the Outpatient Department of Neurology of 52 general hospitals in China. After the baseline evaluation, topiramate was given at the target dose of 200 mg/day over an 8-week titration period. In the subsequent 12-week maintenance period, the topiramate dose was adjusted （200-300 mg） according to the clinical results. The patients were followed up for 6 months, with monthly visits and regular physical, neurological and laboratory examinations. Results After the maintenance period, 106 patients （89.1%） showed a seizure frequency reduction by 50% or greater from the baseline, among whom 65 patients（93.8%）received the monotherapy and 54（83.8%） had the add-on therapy. Topiramate monotherapy and add-on therapy resulted in a complete seizure control in over 50% of the patients with various types of seizure. In patients with disease course less than 1 year, between 1 and 3 years, between 4 and 6 years, and over 6 years, topiramate monotherapy resulted in seizure reduction by 92.86%, 91.67%, 100%, and 94.44%, and the add-on therapy reduced the seizure by 80.00%, 85.71%, 70.00%, and 86.36%, respectively. When combined with carbamazepine, valproate sodium, phenytoin, phenol barbital, and diazepam, the total effective rate oftopiramate was 79.41%, 87.50%, 85.71%, 0%, and 80.00%, respectively. Topiramate, especially in monotherapy, caused only mild or moderate adverse effects. Conclusion Topiramate is effective and safe for either monotherapy or add-on therapy of epilepsy in elderly patients. The types of epilepsy, disease course, or the drugs used in the add-on therapy do no obviously affect the efficacy of topiramate for seizure control.