托吡酯与卡马西平对照治疗成人癫痫133例

Efficacy and tolerability of topiramate compared with carbamazepine in newly diagnosed adults with partial epilepsy

目的:比较托吡酯(TPM)及卡马西平(CBZ)单药治疗新诊断的部分性发作成人癫痫患者的疗效及耐受性。方法:133例患者入组,自愿选择进入TPM组58例和CBZ组75俐。起始剂量TPM 25mg·d^(-1),qd,CBZ100mg·d^(-1),bid。根据患者的发作情况及是否发生不良反应调整剂量,并充分观察该剂量下的疗效及耐受性,以达最佳或最终剂量。通过比较两组患者治疗前后的月平均发作次数变化和因不良反应退出试验的病例比例评价药物的总体疗效。结果:观察时间TPM组(8.10±6.35)个月,CBZ组(15.69±10.23)个月。最佳或最终剂量范围TPM组50～300mg·d^(-1),CBZ组100～600mg·d^(-1)。按照发作频率减少≥50%、无效或发作增加、因不良反应退出试验分级,两组比较差异有显著性,两组总有效率分别为75.9%及68.0%(P=0.0336),因不良反应退出比例TPM组明显低于CBZ组(1.7% vs 14.7%)。结论:TPM单药治疗成年新诊断部分性发作癫痫患者的疗效与CBZ相当,专全性和耐受性明显优于CBZ。

Objective:To evaluate the efficacy and tolerability of topiramate (TPM) versus carbamazepine (CBZ) in adults who were newly diagnosed with partial epilepsy. Methods: 133 adults with partial epilepsy who were diagnosed within 3 months were initiaily administrated with either TPM (25mg·d^(-1)) or CBZ (200mg·d^(-1)). The dosages were gradually escalated during the treatment until the optimal efficacy and tolerability of the therapy were achieved. The primary endpoints of the study were to evaluate the seizure frequency reduction by 50 percent,or no reduction and worsening prior to and post the dosing level, together with the patient proportion of discontinuation from the study due to adverse events at every dosing level in each treatment group. Results: The mean investigation and follow-up time were (8.10±6.35) months for TPM group, (15.69±10.23) months for CBZ group. The optimal dose range of TPM was 50～300mg·d^(-1), and CBZ 100～600mg·d^(-1). Overall efficacy of 75.9% and 68.0% were shown for the patients in the TPM and CBZ groups, respectively (P= 0.0336). Patients taking TPM presented a lower incidence of withdrawal from the study due to adverse events than those treated with CBZ (1.7% vs. 14.7% ). Conclusion : TPM showed a more favorable efficacy and safety in treatment of adult patients newly diagnosed with partial epilepsy than CBZ.