拉莫三嗪联合丙戊酸钠治疗小儿癫痫疗效与安全性的Meta分析

Meta-Analysis on Efficacy and Safety of Lamotrigine Combined with Sodium Valproate in the Treatment of Epilepsy in Children

目的:系统评价拉莫三嗪联合丙戊酸钠治疗小儿癫痫的安全性和疗效。方法:检索中国生物医学数据库(CBM)、维普、中国知网、万方、PubMed、EMBase、the Cochrane Library、Web of Science等数据库,检索时限为建库至2023年2月。筛选有关丙戊酸钠和拉莫三嗪治疗小儿癫痫的随机对照试验(RCT),对照组给予丙戊酸钠常规治疗,试验组在对照组的基础上联用拉莫三嗪治疗。结果:共纳入22项研究进行Meta分析,结果显示,试验组患儿治愈率(OR=2.47,95%CI 1.62~3.77,P<0.01)、显效率(OR=2.06,95%CI 1.57~2.70,P<0.01)、总有效率(OR=3.96,95%CI 2.80~5.61,P<0.01)高于对照组,差异均有统计学意义。不良反应发生率(OR=0.53,95%CI 0.40~0.71,P<0.01)、治疗后癫痫发作频率(MD=-2.91,95%CI-4.01~-1.80,P<0.01)、超敏C反应蛋白(hs-CRP)水平(MD=-4.02,95%CI-4.30~-3.74,P<0.01)、肿瘤坏死因子-α(TNF-α)水平(MD=-26.47,95%CI-27.21~-25.74,P<0.01)、同型半胱氨酸(Hcy)水平(MD=-5.09,95%CI-5.37~-4.80,P<0.01)低于对照组,差异均有统计学意义。结论:丙戊酸钠联合拉莫三嗪治疗小儿癫痫在治愈率、显效率、总有效率方面均显著优于单独使用丙戊酸钠,可明显降低不良反应发生率、治疗后癫痫发作频率以及hs-CRP、TNF-α、Hcy水平。

Objective:To systematically review the safety and efficacy of lamotrigine combined with sodium valproate in the treatment of epilepsy in children.Methods:China Biology Medicine(CBM),VIP,CNKI,Wanfang,PubMed,EMBase,the Cochrane Library and Web of Science databases were retrieved,the retrieval time was from the establishment of the database to Feb.2023.Randomized controlled trials(RCT)of sodium valproate and lamotrigine in the treatment of epilepsy in children were screened.The control group received conventional treatment with sodium valproate,while the experimental group was given lamotrigine on the basis of control group.Results:A total of 22 RCT were included for Meta-analysis.Results showed that cure rate(OR=2.47,95%CI from 1.62 to 3.77,P<0.01),significant effective rate(OR=2.06,95%CI from 1.57 to 2.70,P<0.01),total effective rate(OR=3.96,95%CI from 2.80 to 5.61,P<0.01)in the experimental group were significantly higher than those in the control group,with statistically significant differences.The incidence of averse drug reactions(OR=0.53,95%CI from 0.40 to 0.71,P<0.01),epileptic seizure frequency after treatment(MD=-2.91,95%CI from-4.01 to-1.80,P<0.01),levels of hypersensitive C-reactive protein(hs-CRP,MD=-4.02,95%CI from-4.30 to-3.74,P<0.01),levels of tumor necrosis factor-α(TNF-α,MD=-26.47,95%CI from-27.21 to-25.74,P<0.01),levels of homocysteine(Hcy,MD=-5.09,95%CI from-5.37 to-4.80,P<0.01)in the experimental group were significantly lower than those in the control group,with statistically significant differences.Conclusion:Lamotrigine combined with sodium valproate in the treatment of epilepsy in children is significantly better than sodium valproate alone in terms of cure rate,significant effective rate and total effective rate,and could significantly reduce the incidence of adverse drug reactions,epileptic seizure frequency after treatment and levels of hs-CRP,TNF-αand Hcy.