摘要
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 assess the efficacy and tolerability on Chinese refractory partial-onset seizures. Methods The study included an 8-week baseline period followed by 8-week titration period and 12-week stabilization periodDuring the 8-week baseline period,patients were required to have at least 4 seizures per month despite medication with 1 to 3 standard anti-epilepsy drugs (AED)During the titration period,patients were started with 25 mg TPM per day for 1 week Subsequently,the dosage increment for each 1-week titration interval was 25 mg TPM until the assigned target dosage 200 mg per day Patients were then continued at that dosage through the 12-week stabilization period.Results 431 patients were selected for the study There was a 50% or greater reduction from baseline in seizure frequency in 326 cases (75.6%),≥75% in 257 cases (59.6%),100% in 91 cases (21.1%) Seizure increased≥25% was in 18 cases (4.2%)For the seizure types,seizure reduction≥50% in SPS was 83.3%; CPS was 74.4%; and partial seizure with secondary generalized seizure was 82.1%The adverse events tended to be mild-to-moderate severity.Conclusion TPM has proven effective as an add-on therapy in refractory partial seizure with or without secondary generalized seizure and with a good safety profile after oral administration
出处
《中华神经科杂志》
CAS
CSCD
北大核心
2001年第3期132-134,共3页
Chinese Journal of Neurology
