加巴喷丁对难治性癫痫的治疗作用

Curative effect of gabapentin on refractory epilepsy

目的评价加巴喷丁在难治性癫痫治疗中的有效性和安全性。方法采用多中心随机双盲研究,用加巴喷丁添加治疗难治性癫痫,观察有效性和安全性。随机入组病例140例,进入疗效分析的为138例,治疗组66例,安慰剂组72例。结果服用加巴喷丁的病人每4周随访时的癫痫发作次数均减少,且在用药后第8、12、20周与对照组的差异有统计学意义。治疗有效率在用药后第12周、第20周与对照组的差异有统计学意义,且在全身强直阵挛发作者和部分性发作继发全身性发作者中更明显。安全性二组差异无统计学意义。结论加巴喷丁添加治疗难治性癫痫较安慰剂组能减少癫痫发作次数,提高治疗有效率,加巴喷丁是一个安全性较好的药物。

Objective To assess the safety and efficacy of gabapentin in treatment of refractory epilepsy.Methods Sixty-six patients with refractory epilepsy were treated with gabapentin 200mg/d and 72 patients with placebo, totally 138 patients in five hospitals in different cities in China. Double-blind study was performed to observe the times of seizure, and Mini-Mental State Examination (MMSE) and Activities of Daily Life (ADL) assessment were conducted every 4 weeks.Results In comparison with the control group, the seizure times at any time point in the GB group all decreased with significant differences at the 12th and 20th weeks. The significant efficacy rates, with the seizure times decreasing by more than 75%, in the gabapentin group were higher than those in the control group, with significant differences in the 4, 8, 16, and 20th weeks. Both the MMSE scores of the 2 groups were raised with a significant difference between the 2 groups at the 16 weeks. There was no significant difference in ADL between these 2 groups. No serious side effect was found in these 2 groups.Conclusion Gabapentin at a dosage of 1200 mg/d is safe and effective in treatment of epilepsy.