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目的 采用不同剂量的托吡酯治疗27例儿童原发性全身强直阵挛性癫痫(GTCS)的长期开放性研究。方法 TPM治疗的平均时间为520±190 d(范围235～660 d),TPM经加量期和稳定期后继续治疗3个月和6个月的平均剂量为4.13 mg╱(dg·d)。结果 在最后观察中,GTCS发作频率减少率约80％。接受不同剂量TPM(<4mg╱(kg·d),4～8mg╱(kg·d),>8mg╱(kg·d)的治疗反应大致相同(P>O.05)。而最常见的不良反应为中枢神经系统的表现。经过2年的治疗,仅2例(7.4％)患儿因不良反应和发作未得到适当的控制而未继续用药。结论 TPM在长期开放性治疗儿童原发性全身强直阵挛性癫痫具有良好的耐受性和安全性,尤可用于不能明确区分或分类的癫痫综合征。TPM可作为基础抗癫痫药物失败后长期控制GTCS的广谱的抗癫痫药。
Objective To investigate the long-term open-label study of 27 children with primary tonic-clonic epilepsy (GTCS) treated with different doses of topiramate. Methods The mean duration of TPM treatment was 520 ± 190 days (range 235-660 days). The mean dose of TPM for 3 and 6 months after the addition and stabilization periods was 4.13 mg / (dg · d), respectively. Results In the final observation, the reduction rate of GTCS seizure frequency was about 80%. The response to treatment with different doses of TPM (<4 mg / (kg · d), 4-8 mg ╱ (kg · d), and> 8 mg ╱ (kg · d)) was approximately the same (P> 0.05) After 2 years of treatment, only 2 patients (7.4%) did not receive proper medication due to adverse reactions and seizures.Conclusion TPM is a long-term open treatment of children with primary full body Tonic clonic epilepsy with good tolerance and safety, especially for can not be clearly differentiated or classified epilepsy syndrome .TPM can be used as a basis for long-term control of GTCS after antiepileptic drugs failed antiepileptic drugs.