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拉科酰胺治疗儿童癫痫的疗效和安全性:系统评价和荟萃分析。

Efficacy and safety of lacosamide in pediatric patients with epilepsy: A systematic review and meta-analysis.

机构信息

Department of Pharmacy, Evidence-based Pharmacy Center, West China Second Hospital, Sichuan University, China; Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, China.

Department of Trauma Center Ward 2, West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, China.

出版信息

Epilepsy Behav. 2022 Sep;134:108781. doi: 10.1016/j.yebeh.2022.108781. Epub 2022 Jul 29.

Abstract

OBJECTIVE

Lacosamide (LCM), is a third-generation antiseizure medicine, with limited clinical evidence for use in pediatric populations. We aimed to evaluate evidence for the efficacy and safety of LCM in pediatric patients with epilepsy.

METHODS

A systematic review was performed using literature published from inception to February 2022 identified in MEDLINE, Embase, Cochrane Library, and four Chinese databases. Efficacy and safety outcome data were collected, and a meta-analysis was performed.

RESULT

Twenty-one studies involving 1230 pediatric patients were included. The median percent reduction in seizure frequency per 28 days from baseline to maintenance was 33.1% (95% confidence interval [CI] 22.7%, 43.5%). After 6 months of treatment, the 50%, 75%, and 100% responder rates were 53.3% (95% CI 40.7%, 65.9%), 28.3% (95% CI 20.8%, 35.8%), and 20.4% (95% CI 12.6%, 28.2%), respectively. After 12 months of treatment, the 50%, 75%, and 100% responder rates were 42.0% (95% CI 29.5%, 54.5%), 19.5% (95% CI 11.1%, 27.8%), and 15.2% (95% CI 6.6%, 23.8%), respectively. The most common adverse events (AEs) were drowsiness (15.0%), dizziness (9.9%), and somnolence (8.3%).

CONCLUSION

Lacosamide is generally effective and well tolerated to use in children with epilepsy. However, further research with high-quality data and long-term follow-up of LCM use in pediatric populations is needed.

摘要

目的

拉科酰胺(LCM)是第三代抗癫痫药物,在儿科人群中的临床应用证据有限。我们旨在评估 LCM 在儿科癫痫患者中的疗效和安全性证据。

方法

使用 MEDLINE、Embase、Cochrane 图书馆和四个中文数据库,对从开始到 2022 年 2 月发表的文献进行了系统评价。收集了疗效和安全性结果数据,并进行了荟萃分析。

结果

共纳入 21 项研究,涉及 1230 例儿科患者。从基线到维持期,每 28 天发作频率的中位数减少率为 33.1%(95%置信区间[CI] 22.7%,43.5%)。治疗 6 个月后,50%、75%和 100%应答率分别为 53.3%(95% CI 40.7%,65.9%)、28.3%(95% CI 20.8%,35.8%)和 20.4%(95% CI 12.6%,28.2%)。治疗 12 个月后,50%、75%和 100%应答率分别为 42.0%(95% CI 29.5%,54.5%)、19.5%(95% CI 11.1%,27.8%)和 15.2%(95% CI 6.6%,23.8%)。最常见的不良事件(AE)是嗜睡(15.0%)、头晕(9.9%)和嗜睡(8.3%)。

结论

拉科酰胺治疗儿童癫痫通常有效且耐受良好。然而,需要进一步研究高质量数据和拉科酰胺在儿科人群中的长期使用。

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