托吡酯联合丙戊酸钠对难治性癫痫的疗效和安全性研究

Study on the efficacy and safety of topiramate combined with sodium valproate for refractory epilepsy

目的：评价托吡酯联合丙戊酸钠治疗难治性癫痫的疗效及安全性。方法选取2010年5月~2013年4月我院收治的难治性癫痫患者110例,随机分为观察组和对照组,其中观察组55例,采用托吡酯联合丙戊酸钠治疗,对照组55例,采用单用托吡酯治疗,比较两组患者的临床疗效、脑电图变化及不良反应发生率。结果观察组总有效49例,总有效率为89.09%,对照组总有效41例,总有效率为74.55%,两组患者总有效率比较差异有统计学意义（P〈0.05）,此外观察组显效率及无效率与对照组比较差异均有统计学意义（χ2=3.9111,P〈0.05）；两组患者治疗过程中7例患者发生不良反应,发生率为6.36%,包括头晕、头痛、疲倦、食欲减退及恶心呕吐等,随着治疗的延长,不良反应逐渐缓解,未见皮疹及肝肾等重要脏器损害等严重不良反应发生,两组患者不良反应发生率比较差异无统计学意义。结论托吡酯联合丙戊酸钠治疗难治性癫痫疗效好,值得在临床上予以推广。

Objective To evaluate the efficacy and safety of topamax combined with sodium valproate for treatment of refractory epilepsy. Methods A total of 110 cases of refractory epilepsy admitted and treated in our hospital from May 2010 to April 2013 were selected and randomly assigned to the observation group and the control group. The observa-tion group（55 cases） was treated by topiramate combined with sodium valproate and the control group （55 cases）was treated by topiramate alone. The clinical efficacy, EEG change and incidence of adverse reactions were compared be-tween the two groups. Results The total cases with therapeutic effectiveness were 49 in the observation group with total effectiveness rate of 89.09%. The total cases with therapeutic effectiveness were 41 in the control group with total effec-tiveness rate of 74.55%. The two groups had statistical difference in total effectiveness rate （P〈0.05）. The observation group and the control group also had statistical difference in excellent effectiveness rate and ineffectiveness rate （χ2=3.9111, P〈0.05）. 7 cases of adverse reactions were observed in the two groups during treatment, with incidence of 6.36%, including dizziness, headache, fatigue, anorexia, nausea and vomiting. The adverse reactions were gradually remitted with progress of treatment. No severe adverse reactions were observed, including rash, damage of liver, kid-ney or other important organs. The two groups were comparable in the incidence of adverse reactions,without statistical difference. Conclusion Topamax combined with sodium valproate has good efficacy for treatment of refractory epilepsy,which is worthy of clinical promotion.