托吡酯与丙戊酸钠对照治疗成人癫痫124例

Efficacy and tolerability of topiramate versus valproic acid in adults newly diagnosed with epilepsy

目的:观察托吡酯及丙戊酸钠单药对照治疗新诊断的成人癫痫患者的疗效及耐受性。方法:入组患者124例,其中试验组60例,起始剂量25 mg·d-1,qd,对照组64例,起始剂量丙戊酸钠200 mg·d-1,bid。根据患者发作情况及药物不良反应调整剂量,观察药物的疗效及耐受性,以达最佳或最终剂量。通过比较2组患者治疗前后的月平均发作次数和退出试验的病例比例评价药物的总体疗效。结果:观察时间试验组(8．10±6．44)个月,对照组(14．16±11．75)个月。最佳或最终剂量范围试验组50～300 mg·d-1。对照组200～1500 mg·d-1。两组总有效率分别为78．33％及59．38％,两组比较差异有显著性(P=0．0383)。试验组和对照组分别有2例和1例因不良反应退出或换药。结论:托吡酯单药治疗成年新诊断癫痫患者的疗效好于丙戊酸钠,具有较好的安全性和耐受性。

Objective：To compare the efficacy and tolerability of topiramate （TPM） to valproic acid （VPA） as monotherapy in adults newly diagnosed with epilepsy. Methods： 124 adult patients who were diagnosed with epilepsy within 3 months were randomly administered with an initial dose of TPM 25 mg daily （ n = 60, qd） or VPA 200 mg daily （ n = 64, bid）. The optimal dosages of both drugs were then adjusted based on the episodes status and tolerability of patients during the follow-up treatment. The overall efficacy of the therapy was evaluated based on the improvements of seizure frequency pre-and post-treatment and the ratio of discontinuation due to adverse events. Results： The mean period patients had TPM and VPA was （8.10 ±6.44） and （ 14. 16 ± 11.75 ） months, respectively. The optimal dosages of TPM and VPA were 50 ～ 300 and 200 ～ 1 500 mg· d^-1 , respectively. Compared with the efficacy rate of 59.38% in VPA-treated patients, TPM-treated patients experienced a significant improvement rate of 78.33% in seizure control and frequency reduction （P = 0. 038 3 ）. The patients tolerated TPM better than VPA. Conclusion： TPM offered a better option than VPA in the treatment of adult patients with epilepsy.