拉莫三嗪片联合左乙拉西坦片治疗癫痫部分性发作的临床研究

Clinical trial of lamotrigine tablets combined with levetiracetam tablets in the treatment of partial seizures of epilepsy

目的观察拉莫三嗪片联合左乙拉西坦片治疗癫痫部分性发作的临床疗效和安全性。方法将118例部分性癫痫患者随机分为A组40例、B组40例和C组38例。A组给予口服左乙拉西坦初始剂量为每次0.5 mg,bid,可根据症状调整剂量,最大不超过每次1.5 mg,bid;B组在A组治疗的基础上,给予口服拉莫三嗪每次50 mg,qd;C组给予口服拉莫三嗪初始剂量每次25 mg,qd,治疗2周;随后增加至每次50 mg,qd,连服2周,此后每隔1~2周增加剂量,最大可调整至100~200 mg·d^-1,分2次服用。3组患者均治疗6个月。比较3组患者的临床疗效、生活质量,以及药物不良反应的发生情况。结果治疗后,A、B、C组的总有效率为62.50%(25例/40例),87.50%(35例/40例)和68.42%(26例/38例),生活质量评分分别为(60.38±9.45),(80.02±20.16)和(72.54±15.72)分,B组的上述指标与A、C组比较,差异均有统计学意义(均P<0.05)。A组发生的药物不良反应有消化不良和腹泻,B组发生的药物不良反应有皮疹和恶心,C组发生的药物不良反应有皮疹和头晕。A、B、C组的总药物不良反应发生率分别为7.50%,7.50%和5.26%,差异均无统计学意义(均P>0.05)。结论拉莫三嗪片联合左乙拉西坦片治疗癫痫部分性发作的临床疗效确切,其能显著地改善患者生活质量,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of lamotrigine tablets combined with levetiracetam tablets in the treatment of partial seizures of epilepsy.Methods A total of 118 patients with partial epilepsy were randomly divided into group A(n=40 cases),group B(n=40 cases)and group C(n=38 cases).Group A was given oral levetiracetam at an initial dose of 0.5 mg each time,bid,which could be adjusted according to the symptoms,the maximum dose was not more than 1.5 mg each time,bid.Group B received oral lamotrigine 50 mg each time on the basis of group A,qd.Group C was given oral lamotrigine initial dose of 25 mg,qd,for 2 weeks,then increased to 50 mg each time,qd,for 2 weeks.After that,the dose increased every 1-2 weeks,and the maximum dose could be adjusted to 100-200 mg·d^-1,and taken twice.Three groups were treated for 6 months.The clinical efficacy,quality of life and adverse drug reactions were compared between three groups.Results After treatment,the total effective rates of groups A,B,and C were 62.50%(25 cases/40 cases),87.50%(35 cases/40 cases)and 68.42%(26 cases/38 cases),the quality of life scores were(60.38±9.45),(80.02±20.16)and(72.54±15.72),the differences were statistically significant between group B and groups A,C(all P<0.05).The adverse drug reactions in group A were dyspepsia and diarrhea,which were rash and nausea in group B and rash and dizziness in group C.The total incidences of adverse drug reactions in groups A,B,and C were 7.50%,7.50%,and 5.26%without significant differences(all P>0.05).Conclusion Lamotrigine tablets combined with levetiracetam tablets have a definitive clinical efficacy in the treatment of partial seizures of epilepsy,which can significantly improve the quality of life,without increasing the incidence of adverse drug reactions.