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一项关于左乙拉西坦治疗小儿癫痫患者的随机对照试验的荟萃分析。

A meta-analysis of randomized controlled trials on levetiracetam in the treatment of pediatric patients with epilepsy.

作者信息

Zhang Lanlan, Wang Chengzhong, Li Wei

机构信息

Department of Pediatric Neurology, Yancheng Maternal and Child Health Hospital.

Department of Medical Imaging, Jiangsu Vocational College of Medicine, Yancheng, China.

出版信息

Neuropsychiatr Dis Treat. 2018 Mar 14;14:769-779. doi: 10.2147/NDT.S151413. eCollection 2018.

Abstract

OBJECTIVE

To evaluate clinical efficacy, safety, and tolerability of levetiracetam as mono- or adjunctive therapy in the treatment of children and adolescents with epilepsy.

MATERIALS AND METHODS

We performed a meta-analysis of randomized controlled trials published from January 2007 to December 2016 in the databases Web of Science, Medline, Embase, Cochrane Library, and PubMed, Bing, Baidu, Google Scholar, Chinese National Knowledge Infrastructure (CNKI), and Wanfang Data. All of the studies eligible were compared for the efficacy, safety, and tolerability of levetiracetam with other antiepileptic drugs (AEDs) in epilepsy.

RESULTS

Thirteen randomized controlled trials on a total of 1,013 patients met the inclusion criteria in present study. Compared with other AEDs (oxcarbazepine, valproate, sulthiame, carbamazepine, and placebo), we found that levetiracetam had a comparable seizure-free rate (RR 1.16, 95% CI 1.03-1.31; =0.30). Regarding seizure-frequency reduction ≥50% from baseline, levetiracetam also seemed equivalent to other AEDs (RR 1.08, 95% CI 1.01-1.16; =0.35). In spite of patients treated with levetiracetam having a lower incidence of side effects compared with patients treated with other AEDs (RR 0.90, 95% CI 0.77-1.06), the difference between them was minute and not statistically significant (=0.22).

CONCLUSION

Based on this meta-analysis, it seemed that levetiracetam had comparable effects concerning efficacy, tolerability, and adverse events. Nevertheless, 13 studies were insufficient to draw a conclusion that levetiracetam is effective as mono- and adjunctive therapy for all types of epilepsy syndromes and seizures. Larger-sample and more well-designed trials are needed to justify the widespread use of levetiracetam in the treatment of children and adolescents.

摘要

目的

评估左乙拉西坦作为单药治疗或辅助治疗药物用于治疗儿童和青少年癫痫的临床疗效、安全性和耐受性。

材料与方法

我们对2007年1月至2016年12月期间发表在科学网、医学期刊数据库、荷兰医学文摘数据库、考克兰图书馆、美国国立医学图书馆数据库、必应、百度、谷歌学术、中国知网和万方数据等数据库中的随机对照试验进行了荟萃分析。所有符合条件的研究均比较了左乙拉西坦与其他抗癫痫药物(AEDs)治疗癫痫的疗效、安全性和耐受性。

结果

本研究中共有13项涉及1013例患者的随机对照试验符合纳入标准。与其他抗癫痫药物(奥卡西平、丙戊酸盐、舒噻美、卡马西平和安慰剂)相比,我们发现左乙拉西坦的无癫痫发作率相当(RR 1.16,95% CI 1.03 - 1.31;P = 0.30)。关于自基线起癫痫发作频率降低≥50%,左乙拉西坦似乎也与其他抗癫痫药物相当(RR 1.08,95% CI 1.01 - 1.16;P = 0.35)。尽管与接受其他抗癫痫药物治疗的患者相比,接受左乙拉西坦治疗的患者副作用发生率较低(RR 0.90,95% CI 0.77 - 1.06),但两者之间的差异微小且无统计学意义(P = 0.22)。

结论

基于这项荟萃分析,左乙拉西坦在疗效、耐受性和不良事件方面似乎具有相当的效果。然而,13项研究不足以得出左乙拉西坦作为单药治疗和辅助治疗对所有类型癫痫综合征和发作均有效的结论。需要更大样本量和设计更完善的试验来证明左乙拉西坦在治疗儿童和青少年癫痫方面的广泛应用是合理的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7bda/5857150/3054b8625c89/ndt-14-769Fig1.jpg

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