Sachdeo R C, Reife R A, Lim P, Pledger G
University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick 08903-0019, USA.
Epilepsia. 1997 Mar;38(3):294-300. doi: 10.1111/j.1528-1157.1997.tb01120.x.
Evaluation of topiramate (TPM) as monotherapy in patients with uncontrolled partial onset seizures.
A total of 48 patients were evaluated in a double-blind, parallel-group trial. During a 56-day baseline period, patients had at least eight partial onset seizures while being treated with one or two standard antiepileptic drugs (AEDs). After 1-2 weeks of open-label treatment with TPM 100 mg/day, patients were randomly assigned, in equal proportions, to receive double-blind therapy with TPM 100 or 1,000 mg/day in a 5-week conversion and an 11-week monotherapy period. The study endpoint was completion of 112 study days (success) or fulfillment of one or more exit criteria: doubling of average 28-day or highest 2-day baseline seizure rate, a generalized tonic-clonic seizure (GTCS) if none had occurred at baseline, or significant prolongation of generalized seizure duration.
Time until exit was longer (p = 0.002) and success frequency was higher (p = 0.005) with TPM 1,000 as compared with 100 mg/day. Seizure-rate reductions of > or = 50, > or = 75, or 100% were achieved by 46, 25, and 13% of the 1,000-mg/day group, respectively, as compared with 13, 8, and 0% of the 100-mg/day group, respectively. Most adverse events (AE) were mild or moderate in severity.
Monotherapy with TPM 1,000 mg/day for partial onset seizures with or without secondarily generalized seizures was effective, with a favorable safety profile.
评估托吡酯（TPM）作为单药治疗用于部分性发作未得到控制患者的疗效。
在一项双盲、平行组试验中对48例患者进行了评估。在为期56天的基线期内，患者在接受一种或两种标准抗癫痫药物（AEDs）治疗时至少有8次部分性发作。在接受100mg/天TPM的开放标签治疗1 - 2周后，患者被等比例随机分配，在为期5周的转换期和11周的单药治疗期接受100或1000mg/天TPM的双盲治疗。研究终点为完成112个研究日（成功）或满足一项或多项退出标准：平均28天或最高2天基线发作率翻倍、若基线时未发生则出现全面强直阵挛发作（GTCS）或全面性发作持续时间显著延长。
与100mg/天相比，1000mg/天TPM组的退出时间更长（p = 0.002）且成功频率更高（p = 0.005）。1000mg/天组分别有46%、25%和13%的患者实现了发作率降低≥50%、≥75%或100%，而100mg/天组分别为13%、8%和0%。大多数不良事件（AE）的严重程度为轻度或中度。
1000mg/天TPM单药治疗伴有或不伴有继发性全面性发作的部分性发作有效，且安全性良好。
