托吡酯单用及添加治疗癫痫302例临床分析

Topiramate in monotherapy and concomitant therapy for epilepsy

目的 观察托吡酯添加和单药治疗癫痫的临床疗效及不良反应 ,并探讨单药治疗的理想给药模式。方法 入组患者分为 3组 ,A组 10 2例采用托吡酯添加治疗 ,B组 2 0 0例采用托吡酯单药治疗 ,按初始剂量及加量速度不同 B组又分为 B1组、B2组。B1组 10 5例 ,妥泰初始剂量 2 5 mg/ d,增量 2 5 m g/ w至 2 0 0 m g/ d;B2组 95例 ,妥泰初始剂量 5 0 mg/ d,增量 5 0 m g/ w至 2 0 0 m g/ d。维持治疗 12周。记录发作情况及不良反应。结果 A组总有效率及控制率分别为 6 0 .8%、2 4 .5 % ,B组总有效率及控制率为 76 .8%、4 1.5 % ,两组疗效差异有显著性意义 (P<0 .0 5 )。 B1组总有效率及控制率分别为 77.9%、4 1.9% ,B2组总有效率及控制率分别为 75 .8%、4 0 .0 % ,两组疗效差异无显著性意义 (P>0 .0 5 )。托吡酯对各型部分性发作及强直 -阵挛性发作的疗效差异无显著性意义 (P>0 .0 5 )。B2组不良反应高于 B1组 ,差异有显著性意义 (P<0 .0 5 )。结论 托吡酯添加及单药治疗癫痫具有良好的疗效 ,对发作频率较低的患者宜选用小剂量起始缓慢加量的治疗方法 。

Objective To evaluate the efficacy and tolerability of topiramate(TPM) for epilepsy in add-on or monotheraphy and discuss optimal titration schedule. Methods 102 cases in group A received TPM as concomitant antiepileptic drugs(AEDs). Group B receiving TPM monotherapy and was divided into group B1 with 105 cases and group B2 with 95cases. The starting dose of TPM was 25mg/day and the dose was increased weekly by 25mg/day until 200mg/day was reached in group B1. The starting dose of TPM was 50mg /day and the dose was increased weekly by 50mg/day until 200mg/day was reached in group B2. Seizures and adverse events (AE) were recorded. Results 60.8% of patients in group A experienced a seizure reduction of >or=75% and 24.5% were seizure-free while in group B were 76.8% and 41.5% respectively. There was significant difference between them( P<(0.05)). There were 77.9% of group B1 and 75.8% of group B2 responded with >or =50% decrease in seizure frequency. The seizure-free were 41.9% in group B1 and 40.0% in group B2.The difference of decrease of seizure between groupB1 and group B2 was not significant( P>(0.05)). The efficacy of TPM to the three kinds of partial seizure and generalized tonic-clonic seizure was not of significant difference (P>(0.05)). AE in group B2 was more remarkable than group B1 and the difference was significant. Conclusion TPM is effective to epilepsy not only as add-on as well as monotheraphy. A slower dose-titration with lower initial dose is preferable to patients with low seizure frequency while a faster-titration dose with higher initial dose is recommended to patients with high seizure frequency.