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丙戊酸联合拉莫三嗪治疗各型癫痫的疗效及安全性研究 被引量:69

Efficacy and safety of the combined therapy of valproic acid and lamotrigine for epileptics
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摘要 目的探讨丙戊酸(VPA)联合拉莫三嗪(LTG)治疗各型癫痫的疗效及安全性。方法选择2009年1月至2011年9月间就诊于华中科技大学同济医学院附属同济医院癫痫中心的癫痫患者,采用随机数字表法随机选择患者人组,进行前瞻f生随访研究。分为儿童组及成人组,在3、6、12个月3个时间点分别记录发作频率,分析发作频率的改变情况,计算50%、75%有效率及发作完全控制比率,记录患者随访治疗过程中的不良反应,从而评估联合治疗的疗效及安全性。对比不同时间点的数据评定疗效的长期性,并分析疗效与发作类型的相关性。采用t检验,方差分析中均数的两两比较及计数资料的卡方检验进行统计学分析。结果共收集患者134例,其中10例退出。在3、6、12个月3个时间点,儿童组每月发作频率减少的平均百分率分别为:56%、62%、70%;成人组每月发作频率减少的平均百分率分别为:74%、82%、85%,成人组稍高于儿童组。联合治疗第3个月时50%、75%有效率及发作完全控制比率即可达:儿童组70.97%-35.48%,成人组83.87%-43.01%,至联合治疗后的6个月,12个月时仍可达较高比率,与3个月相比差异无统计学意义(P〉0.05)。CPS及SGTCS疗效差于SPS及GS(P〈0.05)。皮疹是退出治疗的主要不良反应。结论VPA与LTG联合治疗对各型癫痫均有效,可维持疗效稳定长达1年,且对SPS及Gs疗效更佳;联合治疗后不良反应无增加,安全性好。 Objective To explore the efficacy and safety of the combined therapy of valproic acid (VPA) and lamotrigine (LTG) for various types of epilepsy. Methods The patients were recruited from the epilepsy center at Affiliated Tongji Hospital, Tongji Medical College, Huazhong Science & Technology University from January 2009 to September 2011. They were randomly selected through a number chart and divided into two groups: child group and adult group. The prospective follow-up study lasted for one year to examine the long-term efficacy and safety of combined therapy. Seizure frequency was recorded at Months 3, 6 and 12. The changes of seizure frequency were analyzed to calculate the 50% response rate, 75% response rate and seizure-free rate. All side effects during therapy were recorded. The correlation of efficacy with seizure type was also examined. Statistical analysis was performed through t test, variance analysis and X^2 test. Results Among a total of 134 patients, 10 of them withdrew. At Months 3, 6 and 12, as compared with baseline, the average reduction rate of seizure frequency per month was 56%, 62%, 70% in child group versus 74%, 82%, 85% in adult group (P 〈 0.05). Adult group was better than child group. At Month 3, 50% response rate, 75% response rate and seizure-free rate was 70.97% -35.48% in child group versus 83.87% -43.01% in adult group. When compared at Months 3, 6 and 12, 50% response rate, 75% response rate and seizure-free rate showed no statistical difference ( P 〉 0. 05 ). The worse outcomes occurred more frequently in the patients with complex partial seizure (CPS) and than those with simple partial seizure (SIX3) and generalized seizure GS (P 〈 0.05). Rash was the major side effect forwithdrawal. Conclusion The co-medication of VPA and LTG is both effective and safe for all epileptic types, especially for SPS and GS. And the efficacy may last for up to one year. Combined therapy shows excellent safety.
出处 《中华医学杂志》 CAS CSCD 北大核心 2012年第17期1174-1178,共5页 National Medical Journal of China
基金 湖北省自然科学基金(2011CDB201)
关键词 丙戊酸 拉莫三嗪 联合治疗 癫痫 Valproic acid Lamotrigine Co-medication Epilepsy
作者简介 通信作者:朱遂强,Email:zhusuiqiang@163.com
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