摘要
目的 评价托吡酯添加治疗儿童难治性癫痫的疗效及安全性。方法 应用托吡酯对44例难治性癫痫患儿进行开放性自身对照临床研究,其中单纯部分性发作患儿14例次,复杂部分性发作患儿23例次,部分性发作继发全面性发作患儿16例次。于服药后6个月评价托吡酯的疗效和安全性,以及临床疗效与药物剂量关系。结果 托吡酯治疗总有效率为58.14％(25/43例次),以发作次数减少≥50％为界,单纯部分性发作患儿治疗总有效率为57.14％(8/14例次),复杂部分性发作63.64％(14/22例次),部分性发作继发全面性发作68.75％(11/16例次)。6例Lennox-Gastaut综合征患儿中仅2例有效。托吡酯治疗后的不良反应发生率为46.51％(20/43例次),主要为厌食(37.21％)和体重下降(27.91％)。托吡酯所致不良反应较轻微,部分患儿继续接受治疗可自行缓解。结论 尽管在服用托吡酯期间须行不良反应监测,但其作为添加剂治疗儿童难治性癫痫安全有效,且对患儿血尿常规、肝肾功能均无明显影响。
Objective To evaluate the efficacy and safety of topiramate (TPM) as adjunctive therapy in children with intractable epilepsy. Methods An open-label, self-controlled study of topiramate as adjunctive therapy was performed in 44 children with intractable epilepsy including simple partial seizur (n=14), complex partial seizure (n=23) and secondary generalized seizure (n=16). The efficacy and safety of TPM, and it relationship with dosage were evaluated after treatment in 6 months. Results The total effective rate of topiramate was 58.14% (25/43) in this study. The effective (defined as seizure reduction ≥50%) rate of topiramate in simple partial seizure, complex partial seizure and secondary generalized tonic-clonic seizure were 57.14% (8/14), 63.64% (14/22) and 68.75% (11/16), respectively. Only 2 responders were found in 6 children with Lennox-Gastaut syndrome. The incidence of adverse effect was 46.51% (20/43). The most common adverse events were anorexia (37.21%) and weight loss (27.91%). These adverse effects were mild, and some of them might disappear in continuing treatment. The significant effect on blood and urine routine test, liver and renal function were not found. Conclusion It is demonstrated that topiramate adjunctive therapy is effective and safe in treatment of children with intractable partial epilepsy, although careful monitoring of adverse events is required during treatment.
