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目的研究托吡酯治疗小儿难治性癫部分性发作的疗效与安全性。方法36例难治性癫部分性发作患儿,原来使用的抗癫药种类和剂量不变,将托吡酯作为辅助治疗药物,从0.5 mg.kg-1.d-1开始,每周增加0.5 mg.k-g1.-d1,目标剂量4.0~9.0 mg.k-g1.-d1,根据癫发作情况调整托吡酯剂量。癫发作被控制后,原用抗癫药物逐渐减量直至停用。结果实验过程中2例失访,2例因不良反应退出观察,其他患儿治疗6个月后,总有效率78.0%,同治疗前比较,总发作频率减少73.0%(P<0.01),其中简单部分性发作频率减少79.0%(P<0.05),复杂部分性发作频率减少71.0%(P<0.05),部分性发作全身泛化发作频率减少67.0%(P<0.01)。治疗至6个月末心电图及肝、肾功能,血、尿常规均未见明显异常。11例患儿在加量期出现轻、中度不良反应,不需特殊处理大多可自行消失。结论托吡酯治疗小儿难治性癫部分性发作疗效确切,安全性高,患儿耐受好。
Objective To study the efficacy and safety of topiramate in treating partial intractable epilepsy in children. Methods Thirty six children with refractory epilepsy were treated with topical antiepileptic drugs and topiramate. Topiramate was used as an adjunctive therapy starting from 0.5 mg.kg-1.d-1, with a weekly increase of 0.5 mg .k-g1.-d1, the target dose of 4.0 ~ 9.0 mg.k-g1.-d1, adjust the dose of topiramate according to epileptic seizures. Epilepsy was controlled, the original anti-epileptic drugs tapering until disabled. Results During the experiment, 2 patients were lost to follow-up and 2 patients were withdrawn from adverse reactions. After 6 months of treatment, the other patients had a total effective rate of 78.0%. Compared with pre-treatment, the total frequency of attacks decreased by 73.0% (P <0.01) The frequency of simple partial seizures decreased by 79.0% (P <0.05), the frequency of complex partial seizures decreased by 71.0% (P <0.05), and the frequency of generalized seizures decreased by 67.0% (P <0.01). At the end of 6 months, ECG and liver, kidney function, blood and urine routine did not show obvious abnormalities. 11 cases of children in the amount of light and moderate adverse reactions, most of them can disappear without special treatment. Conclusion Topiramate treatment of pediatric intractable epilepsy partial seizures effective, safe, good tolerance in children.