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拉莫三嗪治疗儿童和青少年失神发作的疗效和安全性:系统评价和荟萃分析。

The efficacy and safety of lamotrigine for absence seizures in children and adolescents: A systematic review and meta-analysis.

机构信息

Department of Traditional Chinese Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China; Nanjing Medical University, Nanjing, China.

出版信息

J Clin Neurosci. 2020 Jan;71:199-204. doi: 10.1016/j.jocn.2019.08.043. Epub 2019 Aug 26.

Abstract

AIMS

This systematic review and meta-analysis of randomized controlled trials (RCTs) systematically explored the effectiveness and safety of lamotrigine for absence seizures in children and adolescents.

METHODS

Keywords searches were conducted in Pubmed Embase Cochrane Central Register of Controlled Trials Wanfang CNKI from inception through March 2019. The RCTs comparing lamotrigine with other drugs and/or placebo for the treatment of absence seizures in children and adolescents were considered in this study. The study was conducted adhering to PRISMA guidelines.

RESULTS

Eight RCTs (n = 787) were included in our study. Among these studies, one study (N = 45 patients) used placebo as a control and seven studies (N = 742 patients) used positive drug controls. For effectiveness, there was significant difference between lamotrigine and valproate [OR = 0.42, 95%CI (0.28-0.63), I = 0%] or ethosuximide [OR = 0.34, 95%CI (0.22-0.53), I = 0%]. For adverse effects (AEs), there was no significant difference between lamotrigine and valproate [OR = 1.17, 95%CI (0.59, 2.32), I = 0%] or ethosuximide [OR = 0.75, 95%CI (0.47, 1.19), I = 92%], and the most common adverse effects of lamotrigine were Rash (7.88%), Fatigue (6.50%) and Headache (6.50%).

CONCLUSIONS

According to current evidence, LTG is less effective than VPA and ESM, however, based on its relative safety, LTG might be reasonably tried as initial therapy in children and adolescents at risk of significant adverse effects from VPA and ESM, and future well-designed studies are needed to confirm our findings.

摘要

目的

本系统评价和荟萃分析对随机对照试验(RCT)进行了系统研究,旨在探讨拉莫三嗪治疗儿童和青少年失神发作的有效性和安全性。

方法

从建库至 2019 年 3 月,我们在 Pubmed、Embase、Cochrane 中央对照试验注册库、万方和中国知网(CNKI)中进行了关键词检索。本研究纳入了比较拉莫三嗪与其他药物和/或安慰剂治疗儿童和青少年失神发作的 RCT。研究遵循 PRISMA 指南进行。

结果

本研究纳入了 8 项 RCT(n=787)。其中,1 项研究(n=45 例患者)采用安慰剂作为对照,7 项研究(n=742 例患者)采用阳性药物对照。在有效性方面,拉莫三嗪与丙戊酸钠[比值比(OR)=0.42,95%置信区间(CI)(0.28-0.63),I²=0%]或乙琥胺[OR=0.34,95%CI(0.22-0.53),I²=0%]相比差异有统计学意义。在不良反应(AE)方面,拉莫三嗪与丙戊酸钠[OR=1.17,95%CI(0.59, 2.32),I²=0%]或乙琥胺[OR=0.75,95%CI(0.47, 1.19),I²=92%]相比差异无统计学意义,拉莫三嗪最常见的不良反应是皮疹(7.88%)、疲劳(6.50%)和头痛(6.50%)。

结论

根据现有证据,LTG 不如 VPA 和 ESM 有效,但鉴于其相对安全性,LTG 可能是一种合理的选择,可作为有发生 VPA 和 ESM 严重不良反应风险的儿童和青少年的初始治疗药物,还需要未来开展设计良好的研究来证实我们的发现。

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