目的：评价拉莫三嗪对难治性癫痫的治疗作用和安全性。方法：难治性癫痫病人７６例治疗前３ｍｏ开始填写发作的逐日志，完成后随机分成单盲、安慰剂对照（ｎ＝４４）与双盲、交叉、安慰剂对照（ｎ＝３２）２组，保持原用抗痫药不变，按５０～４００ｍｇ／ｄ（未用丙戊酸者）或２５～２００ｍｇ／ｄ（用丙戊酸者），ｑｏｄ，ｑｎ或ｂｉｄ加用拉莫三嗪，对照组用同等剂量的维生素Ｃ，３ｍｏ为一个疗程。结果：拉莫三嗪有效率为５６％，不良反应较轻。结论：拉莫三嗪治疗难治性癫痫是有效和安全的。 Objective: To evaluate the therapeutic effect and safety of lamotrigine on refractory epilepsy. METHODS: Seventy-two patients with refractory epilepsy were enrolled in a randomized, placebo-controlled (n = 44) and double-blind, crossover, placebo-controlled (n = 32) , Keep the original anti-epileptic drugs unchanged, according to 50 ~ 400mg / d (without valproic acid) or 25 ~ 200mg / d (with valproic acid), qod, qn or bid add lamotrigine, The control group with the same dose of vitamin C, 3mo for a course of treatment. RESULTS: Lamotrigine was 56% effective and had mild adverse reactions. Conclusions: Lamotrigine is effective and safe in the treatment of refractory epilepsy.