Department of Pharmacology, Medical School of Southeast University, Nanjing, China; Medical Imaging, Medical School of Southeast University, Nanjing, China.
Clinical Medicine, Medical School of Southeast University, Nanjing, China.
Seizure. 2022 Feb;95:17-25. doi: 10.1016/j.seizure.2021.12.003. Epub 2021 Dec 21.
To estimate the safety and efficacy of sodium valproate combined with levetiracetam in paediatric patients with epilepsy based on randomized controlled trials (RCTs).
The Cochrane Library, PubMed, Web of Science, Chinese Journal Full-Text Database (CNKI), WANGFANG DATA and Sino Med were searched between January 1946 and May 2021. The included literature was randomized controlled clinical trials focusing on sodium valproate combined with levetiracetam in paediatric patients with epilepsy. Two evaluators separately collected the data based on the retrieval strategy, filtered the literature in accordance with the inclusion and exclusion criteria, and summarized the literature that satisfied the criteria. The statistical programme used for the meta-analysis was Stata V14.0.
Of 577 original titles screened, data were extracted from 7 studies (617 participants). Compared with sodium valproate alone or sodium valproate combined with topiramate, the application of sodium valproate combined with levetiracetam in the treatment of paediatric epilepsy significantly improved the overall therapeutic effect (RR=1.24, 95% CI: 1.16 to 1.33, p=0.927). The observation group significantly reduced the occurrence of adverse drug reactions (ADRs) (RR=0.54, 95% CI: 0.37 to 0.79, p=0.602). Egger's regression test of the overall therapeutic effect showed no potential publication bias (p=0.122).
Based on this meta-analysis, compared with sodium valproate alone or sodium valproate with topiramate, the application of sodium valproate combined with levetiracetam in the treatment of paediatric epilepsy can significantly improve the overall therapeutic effect and simultaneously reduce the occurrence of ADR. Therefore, we recommend sodium valproate combined with levetiracetam for the therapy of paediatric patients with epilepsy.
基于随机对照试验（RCTs）评估丙戊酸钠联合左乙拉西坦治疗儿科癫痫患者的安全性和有效性。
检索 1946 年 1 月至 2021 年 5 月 Cochrane 图书馆、PubMed、Web of Science、中国期刊全文数据库（CNKI）、万方数据和 Sino Med 数据库，纳入丙戊酸钠联合左乙拉西坦治疗儿科癫痫患者的 RCT。由 2 名评价者按照检索策略收集资料，根据纳入与排除标准筛选文献，并对符合标准的文献进行资料提取。采用 Stata V14.0 软件进行 Meta 分析。
共筛选出 577 篇原始文献，最终纳入 7 项研究（617 例患者）。与丙戊酸钠单药或丙戊酸钠联合托吡酯相比，丙戊酸钠联合左乙拉西坦治疗儿科癫痫的总有效率更高（RR=1.24，95%CI：1.161.33，p=0.927），不良反应（ADR）发生率更低（RR=0.54，95%CI：0.370.79，p=0.602）。总有效率的漏斗图 Egger 检验结果未见明显发表偏倚（p=0.122）。
基于此 Meta 分析结果，丙戊酸钠联合左乙拉西坦治疗儿科癫痫的疗效优于丙戊酸钠单药或丙戊酸钠联合托吡酯，且可降低 ADR 发生率。因此，我们推荐丙戊酸钠联合左乙拉西坦治疗儿科癫痫患者。
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