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托吡酯片联合拉莫三嗪片治疗癫痫的临床研究 被引量:18

Clinical trial of topiramate tablets combined with lamotrigine tablets in the treatment of epilepsy
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摘要 目的观察托吡酯片联合拉莫三嗪片治疗癫痫的临床疗效及安全性。方法将90例癫痫患者随机分为对照组和试验组,每组45例。对照组给予拉莫三嗪初始剂量25 mg·d-1,qd,口服,用药2周后,增量至50 mg·d-1;之后每2周增加50 mg·d-1,直至200 mg·d-1维持剂量。试验组在对照组治疗的基础上,给予托吡酯初始剂量25 mg·d-1,qd,口服,之后每周增量25 mg·d-1,最大日剂量≤200 mg。2组患者均治疗6个月。比较2组患者的临床疗效和药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为93.33%(42例/45例)和84.44%(38例/45例),差异有统计学意义(P<0.05)。试验组发生的药物不良反应有皮疹和胃肠道不适,对照组发生的药物不良反应有胃肠道不适。试验组和对照组的总药物不良反应发生率分别为4.44%和2.22%,差异无统计学意义(P>0.05)。结论托吡酯片联合拉莫三嗪片治疗癫痫的临床疗效显著优于单用拉莫三嗪,且不增加药物不良反应的发生率。 Objective To observe the clinical efficacy and safety of topiramate tablets combined with lamotrigine tablets in the treatment of epilepsy.Methods Ninety patients with epilepsy were randomly divided into control and treatment groups with 45 cases per group.Control group received lamotrigine at an initial dose of 25 mg·d-1,qd,orally;after 2 weeks of administration, the dose was increased to 50 mg·d-1;and then increased by 50 mg·d-1 every 2 weeks to 200 mg·d-1 maintenance dose.Treatment group was given topiramate with an initial dose of 25 mg·d-1, qd, orally, followed by weekly increment of 25 mg·d-1, with a maximum daily dose of ≤200 mg.Two groups were treated for 6 months.The clinical efficacy and adverse drug reactions between two groups were compared.Results After treatment, the total effective rates of treatment and control groups were 93.33%(42 cases/45 cases) and 84.44%(38 cases/45 cases) with significant difference(P<0.05).The adverse drug reactions of treatment group were rash and gastrointestinal discomfort,which in control group were gastrointestinal discomfort.The total incidences of adverse drug reactions in the treatment and control groups were 4.44% and 2.22% without significant difference(P>0.05).Conclusion The clinicial efficacy of topiramate tablets combined with lamotrigine tablets in the treatment of epilepsy was better than lamotrigine alone,without increasing the incidence of adverse drug reactions.
作者 陈烈冉 张鑫 张保朝 付国惠 孙忠源 CHEN Lie-ran;ZHANG Xin;ZHANG Bao-chao;FU Guo-hui;SUN Zhong-yuan(Department of Internal Medicine-Neurology,Nanyang Central Hospital,Nanyang 473009,Henan Province,China;Department of Emergency,Nanyang 120 Emergency Center,Nanyang 473004,Henan Province,China;Department of Neonatal Surgery,Zhengzhou Children's Hospital,Zhengzhou 450018,Henan Province,China)
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2020年第7期763-765,共3页 The Chinese Journal of Clinical Pharmacology
基金 河南省科技攻关计划课题资助项目(2018020675)。
关键词 托吡酯片 拉莫三嗪片 癫痫 安全性评价 topiramate tablet lamotrigine tablet epilepsy safety evaluation
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