拉莫三嗪添加治疗难治性癫痫的疗效及安全性研究

目的评价拉莫三嗪添加用药治疗难治性癫痫的临床疗效及安全性。方法采用随机、双盲、安慰剂对照、平行设计添加治疗,确诊为有难治性癫痫发作的120例癫痫患者,平均年龄（34.1±14.7）岁,随机分为拉莫三嗪组（n=60）和安慰剂组（n=60）。在回顾8周基线期的癫痫发作频率后,进入逐量加药期。与肝药酶诱导类的AEDs（卡马西平、苯妥英钠和苯巴比妥）合用,初始剂量为50mg/d,2周后增加到100mg/d,逐渐加量至200-400mg/d,维持治疗16周;与丙戊酸类药物或其他非酶诱导剂合用（如托吡酯、加巴喷丁和吡拉西坦等）,初始剂量为25mg/2d,每2周增加25mg/d,逐渐加量至100-200mg/d,维持治疗16周。主要评价指标为16周治疗期内每周癫痫发作频率的比较,得出药物治疗发作频率减少50%有效率,安全性和药物不良反应。结果在8周加药期和16周治疗期内,拉莫三嗪组平均发作频率为1.31次/周,与基线期2.91次/周相比,经配对样本t检验,差异具有统计学意义（P〈0.01）;与安慰剂组2.97次/周相比,经独立样本t检验,差异具有统计学意义（P〈0.01）。拉莫三嗪组总有效率（每周发作频率减少50%以上）为71.67%（43/60）;安慰剂组为5%（3/60）。两组间比较,经x^2检验,差异具有统计学意义（P〈0.001）。拉莫三嗪组的总不良反应率为46.67%,安慰剂组为43.33%,组间比较,经x^2检验,差异无统计学意义（P〉0.05）。主要不良反应为头晕、食欲下降和盗汗等,与安慰剂组相比,差异均无有统计学意义（P〉0.05）。结论拉莫三嗪添加治疗难治性癫痫发作,可以显著减少癫痫发作频率,安全性与安慰剂比较无统计学差异。

A randomized,double blind,controlled study of efficacy and safety of lamotrigine as add-on drug in the management of intractable epilepsy

Objective To evaluate the efficacy and safety of lamotrigine as add-on drug in management of intractable epilepsy.Methods In this randomized,double blind,placebo-controlled trial,lamotrigine was compared with placebo add-on therapy in 120 patients with intractable epilepsy.All patients enrolled an 8 weeks baseline period followed by a add-on drug period.The main evaluation indications were the decrease of seizure frequency per week,the 50% responder rate,and adverse events.Results After add-on drug therapy,the average seizure frequency of lamotrigine group was 1.31 times per week,which was significantly different from the seizure frequency in baseline period（P〈0.05）.After add-on drug therapy,the average seizure frequency of placebo group was 2.97 times per week,which was significant higher than that in lamotrigine group（P〈0.05）.The total effective rates of lamotrigine group and placebo group were 71.67% and 5.00%,respectively.The difference of total effective rates between the two groups was significant（P〈0.05）.However,the total ADR rates between the two groups were not significant.The most common adverse events were dizzy,anorexia and sweats.Conclusion The lamotrigine add-on therapy can effectively control seizure attacks in the management of intractable epilepsy.