托吡酯治疗小儿癫痫的临床研究  

Clinical trial of topiramate in the treatment of the patients with pediatric epilepsy

作　　者：阮学东[1] 陈啸洪[1] 

机构地区：[1]绍兴市人民医院小儿内科,浙江绍兴312000

出　　处：《中国临床药理学杂志》2013年第11期821-822,825,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价托吡酯联合基础药物治疗癫痫患儿的临床疗效及安全性。方法小儿癫痫患者103例,随机分为2组:对照组(54例),服用丙戊酸钠或加氯硝安定[(34.2±12.6),(0.17±0.06)mg·kg-1·d-1];在此基础上,试验组(49例)加用托吡酯,首次服用由1 mg·kg-1·d-1开始,服用1周后,每周增加1 mg·kg-1·d-1,直至有效剂量或出现不能耐受的药物不良反应为止。用药6个月后,比较2组患儿癫痫控制率、药物相关毒性反应及患儿体液免疫功能。结果总有效率:试验组显著高于对照组(78%,58.3%;P<0.05)。嗜睡、淡漠、体重改变等并发症发生率:试验组和对照组分别为34.1%,33.3%(P>0.05)。免疫球蛋白A(IgA)与试验前比较,试验组明显降低(P<0.05),而对照组无明显改变(P>0.05)。结论癫痫患儿在传统药物治疗基础上加用托吡酯,可改变患儿的体液免疫水平,明显降低癫痫的发作频率,且不增加药物毒性反应。Objective To evaluate the clinical efficacy and safety of topiramate combined with traditional medicine in the treatment of the patients with pediatric epilepsy. Methods One hundred and three children with epilepsy recruited subjects were involved. The patients randomized divided into two groups ： control group （ n = 54） were given the clonazepam （0. 17 ＋ 0. 06 ） mg·kg^-1·d^-1 and valproate （34. 2 ±12. 6 ） mg·kg^-1·d^-1. On this basis, the patients in trial group （n = 49） were given the topiramate 1 mg·kg^-1·d^-1in the first week and 1 mg·kg^-1·d^-1 increased perweek until unbearable toxicity. The clinical efficacy, side effects related to topiramate and immunological parameters between the two groups were determined after treatment 6 months. Results The response rate in the trial group had higher than the control group （P 〈 0. 05 ）. And there were no statistical difference between the two groups in the aspects of side effects （sleepiness, indifferent, weight change, et al. P 〉 0.05 ）. The serum level of IgA was significant decreased in the trial group （ P 〈 0. 05 ）. Conclusion Topiramate combined with the traditional medicine can improve children＇s humoral immune function, which significantly reduce frequency of seizures in children with epileps.

关 键 词：小儿癫痫 托吡酯 免疫球蛋白 

分 类 号：R971.6[医药卫生—药品] R749.17[医药卫生—药学]