Objective: To investigate the efficacy and safety of lamotrigine monotherapy in children with epilepsy via a systematic review.
Methods: PubMed, Cochrane, CNKI, VIP, CBM, Wanfang Data were searched for randomized controlled trials (RCTs) of lamotrigine monotherapy in children with epilepsy. Literature screening, data extraction, and quality assessment were performed according to the method recommended by Cochrane Collaboration. RevMan 5.2 software was used to conduct the Meta analysis.
Results: A total of 9 RCTs involving 1 016 participants were included. Lamotrigine yielded a significantly lower complete control rate of seizure than ethosuximide, but the complete control rate of seizure showed no significant differences between lamotrigine and carbamazepine/sodium valproate. Patients treated with lamotrigine had a significantly lower incidence rate of adverse events than those treated with carbamazepine, but the incidence rate of adverse events showed no significant differences between patients treated with lamotrigine and sodium valproate/carbamazepine. The drop-out rate showed no significant differences between the three treatment groups.
Conclusions: Lamotrigine is an ideal alternative drug for children who do not respond to traditional antiepileptic medication or experience significant adverse reactions; however, more high-quality RCTs with a large sample size and a long follow-up time are needed to confirm these conclusions.
目的: 系统评价拉莫三嗪单药治疗儿童癫癎的有效性和安全性。
方法: 计算机检索PubMed、Cochrane图书馆、CNKI、VIP、CBM、万方等中英文数据库，获得拉莫三嗪单药治疗儿童癫癎的随机对照试验。应用Cochrane协作网推荐的方法进行文献筛选，资料提取和文献质量评估，采用RevMan 5.2软件进行Meta分析。
结果: 共纳入9个RCTs（1016例）。拉莫三嗪的癫癎发作完全控制率明显低于乙琥胺，与卡马西平和丙戊酸钠的差异均无统计学意义。拉莫三嗪的不良反应发生率明显低于卡马西平，与丙戊酸钠和乙琥胺的差异均无统计学意义；3种药物的退出率比较差异无统计学意义。
结论: 对于传统抗癫癎药物治疗无效、不良反应明显患儿，拉莫三嗪是一种较为理想的替代药物。但仍有待高质量、大样本及较长随访时间的随机对照试验予以证实。