添加托吡酯治疗癫痫的临床研究

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

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 5 0mg·d-1,2周后为 10 0mg·d-1,分 2次服用 ,维持剂量 2 0 0～ 40 0mg·d-1。以治疗前 3个月的发作频度和EEG改变为基础 ,治疗 3和 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 .0 1)。总有效率 (显效 +有效 )分别为 6 1.70 %和 82 .98% ,差异显著 (P <0 .0 1) ;EEG异常率 (高度和中度不正常 )也由原来的 2 3 .4%和 2 5 .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 5 9.6 %和 2 9.8% ,差异有显著性 (P <0 .0 1)。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。

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. [