论文部分内容阅读
目的 评价托吡酯 (topiramate ,TPM)对难治性癫痫部分性发作的疗效及耐受性。方法 采用多中心开放性试验的方法对全国 5 2家医院的 431例病人进行托吡酯添加治疗。本研究包括 8周基础期、8周加量期及 12周稳定观察期。在 8周基础期 ,病人虽用 1～ 3种抗癫痫药治疗 ,但仍有每月至少 4次的发作 ;在加量期 ,TPM开始量为 2 5mg/d ,持续 1周 ,以后每周增加 2 5mg/d ,直到目标剂量达到 2 0 0mg/d ,维持此剂量 12周为稳定观察期。结果 431例病人参加此项研究 ,其中癫痫发作频率减少≥ 5 0 %者为 32 6例 (75 6 % ) ,≥ 75 %者为 2 5 7例 (5 9 6 % ) ,减少 10 0 %者为 91例 (2 1 1% )。 18例 (4 2 % )发作频率增加≥ 2 5 %。就发作类型而言 ,癫痫发作频率减少≥ 5 0 %者中 ,单纯部分性发作(SPS)为 83 4% ,复杂部分性发作 (CPS)为 74 4% ,部分发作继发全身性发作为 82 1%。未出现严重的副作用。结论 TPM对癫痫部分性发作伴有或不伴有继发全身性发作者有效 ,口服安全。
Objective To evaluate the efficacy and tolerability of topiramate (TPM) in partial seizures of refractory epilepsy. Methods The multicentre open-label method was used to treat topiramate in 431 patients in 52 hospitals in China. This study includes the 8-week base period, 8-week period and 12-week stable observation period. At the 8-week baseline, although the patient was treated with 1 to 3 antiepileptic drugs, there was still at least 4 episodes per month; at the additional dose, the initial dose of TPM was 25 mg / day for 1 week and thereafter every week An increase of 25mg / d until the target dose of 200mg / d, maintaining this dose for 12 weeks for the stable observation period. Results A total of 431 patients were enrolled in this study. Of these, 32 6 (75 6%) had a reduction in seizure frequency ≥ 50%, 25 7 (596%) ≥ 75%, and 10 0% 91 cases (21.1%). Eighteen patients (42%) increased seizure frequency by 25%. In terms of the type of seizure, seizure frequency was reduced ≥ 50%, the simple partial seizure (SPS) was 83 4%, complex partial seizures (CPS) 74 4%, partial seizures secondary to systemic seizures 82 1%. No serious side effects. Conclusions TPM is effective and oral safe for partial epilepsy with or without secondary systemic seizures.