添加托吡酯治疗癫痫的临床研究

目的：观察新型抗癫痫药托吡酯（妥泰）添加治疗癫痫的临床疗效和脑电图（EEG）变化。方法：进行开放性自身对照临床试验，对47例经临床和EEG确诊的癫痫患者在原有抗癫痫药物治疗不变的基础上，添加妥泰治疗，初始剂量为50mg.d^-1，2周后为100mg.d^-1，分2次服用，维持剂量200－400mg.d^-1。以治疗前3个月的发作频度和EEG改变为基础，治疗3个6个月后，分别观察发作频度和EEG的变化，并与治疗前进行比较。结果：添加妥泰治疗3和6个月后，发作次数明显减少，尤以治疗6个月后显著（P＜0．01），总有效率（显效＋有效）分别为61．70％和82．98％，差异显著（P＜0．01）；EEG异常率（高度和中度不正常）也由原来的23．4％和25．5％变为治疗3和6个月后的17．0％和19．1％以及0和10．6％，总异常率由原来的70．2％下降至59．6％和29．8％，差异有显著性（P＜0．01）／。结论：妥泰作为一种辅助抗癫痫药物，不仅能明显减少癫痫的发作频度，使EEG异常率显著降低，而且不良反应少，值得临床推广应用。

Study of the efficacy of topiramate added to regimen for treatment of epilepsy

Objective:To observe the efficacy of topiramate added to regimen for treatment of epilepsy.Methods:The open and self-controlled study was conducted in 47 patients with diagonized epilepsy.In addition to their original regimen maintained,they were also treated with topiramate in an initial dose of 50 mg*d-1,then increased to 100 mg*d-1 in 2 divided dose after 2 weeks,and with a maintenance dose of 200～400 mg*d-1 thereafter.The seizure times and EEC changes were observed on the 3rd and 6th months of treatment.The data obtained were compared with those of previous 3 months.Results:After 3 and 6 months treatment of topiramate in addition to original regimen,the seizure times were significantly reduced with a optimum efficacy on 6 months (P<0.01).The total effective rate was 61.7% and 82.9% respectively.The adnormal EEC were also significantly reduced.Conclusion:Topiramate,an adjuvant for epilepsy,can reduce the seizure frequency and adnormal rate of EEC with mild side effects.