Krishnan P R, Tripathi M, Jain S
Department of Neurology, Neurosciences Centre, All India Institute of Medical Sciences, New Delhi, India.
Eur J Neurol. 2003 Sep;10(5):515-9. doi: 10.1046/j.1468-1331.2003.00631.x.
In a prospective open label add-on study on 95 patients (age 1-63 years, mean 17.76 +/- 13.83 years) with seizures refractory to conventional antiepileptic drugs (AEDs) and other new AEDs, the addition of Topiramate (TPM) resulted in seizure worsening in 18 patients (19%) necessitating drug withdrawal over an average follow-up period of 4.94 +/- 1.69 months. Patients who had seizure worsening were older (P = 0.02), were more likely to have had a history of status epilepticus in the past (P = 0.03), were on three conventional AEDs (P = 0.027) or had tried one of the other new AEDs in the past with poor response (P = 0.04). Seven of 18 patients who had seizure worsening with TPM (7.4%) experienced initial seizure worsening, probably representing the subgroup with 'true' seizure worsening whilst 11 (11.6%) had initial improvement followed by 'apparent' seizure worsening. Initial seizure worsening was noted to be significantly more in females when compared with males who worsened after initial improvement (P = 0.05).
在一项针对95例(年龄1至63岁,平均17.76±13.83岁)对传统抗癫痫药物(AEDs)和其他新型AEDs治疗无效的癫痫患者的前瞻性开放标签附加研究中,添加托吡酯(TPM)导致18例患者(19%)癫痫发作恶化,在平均4.94±1.69个月的随访期内需要停药。癫痫发作恶化的患者年龄较大(P = 0.02),过去更有可能有癫痫持续状态病史(P = 0.03),正在服用三种传统AEDs(P = 0.027)或过去曾尝试过其他新型AEDs之一但反应不佳(P = 0.04)。18例因TPM导致癫痫发作恶化的患者中有7例(7.4%)最初癫痫发作恶化,这可能代表了“真正”癫痫发作恶化的亚组,而11例(11.6%)最初有改善,随后出现“明显”癫痫发作恶化。与最初改善后恶化的男性相比,女性最初癫痫发作恶化的情况明显更多(P = 0.05)。