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左乙拉西坦与丙戊酸钠作为单药治疗儿童早期癫痫的比较。

Comparison of Levetiracetam Versus Sodium Valproate as a Monotherapy in Early Childhood Epilepsy.

作者信息

Latif Zainab, Mukhtar Memoona, Rohan Ali, Shah Waseem Farooq, Aslam Zohaib, Akbar Maryam, Raza Hafiz Muhammad Zeeshan

机构信息

Pediatrics, Allama Iqbal Memorial Teaching Hospital, Sialkot, PAK.

Pediatrics, Gujranwala Medical College/Teaching Hospital, Gujranwala, PAK.

出版信息

Cureus. 2025 Jul 9;17(7):e87574. doi: 10.7759/cureus.87574. eCollection 2025 Jul.

DOI:10.7759/cureus.87574
PMID:40786292
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12332517/
Abstract

BACKGROUND

Childhood epilepsy requires long-term management with antiepileptic drugs (AEDs) that are both effective and well-tolerated. Although levetiracetam and sodium valproate are widely used as monotherapies, comparative data on their efficacy and safety in pediatric populations are limited. This study aimed to evaluate and compare their effectiveness and tolerability in children with epilepsy over six months.

METHODS

A randomized controlled study was conducted involving 200 children aged 3 to 12 years with generalized or focal epilepsy. They were randomly assigned to receive either levetiracetam (n=100) or sodium valproate (n=100), and received sodium valproate at an initial dose of 30 mg/kg/day. Efficacy was defined as a threefold increase in seizure-free interval. Side effects were monitored monthly. Data were analyzed using SPSS version 29 with a significance threshold of p<0.05.

RESULTS

Seizure control was achieved in 85% of children in the levetiracetam group and 73% in the sodium valproate group (p=0.037). Absence of side effects was reported in 31% of the levetiracetam group and 10% of the sodium valproate group (p=0.012). Weight gain occurred in 16 children (16.0%) in the sodium valproate group versus 5 children (5.0%) in the levetiracetam group. Other side effects, including hepatotoxicity, rash, somnolence, tremors, and behavioral changes, were comparable between the groups.

CONCLUSION

Levetiracetam appears to be more effective and better tolerated than sodium valproate for the management of pediatric epilepsy. These findings suggest that levetiracetam could be considered a preferred first-line monotherapy. However, further longitudinal studies are warranted to validate these outcomes over longer treatment durations.

摘要

背景

儿童癫痫需要使用有效且耐受性良好的抗癫痫药物(AEDs)进行长期管理。尽管左乙拉西坦和丙戊酸钠被广泛用作单一疗法,但关于它们在儿科人群中的疗效和安全性的比较数据有限。本研究旨在评估和比较它们在癫痫儿童中六个月以上的有效性和耐受性。

方法

进行了一项随机对照研究,纳入200名3至12岁的全身性或局灶性癫痫儿童。他们被随机分配接受左乙拉西坦(n = 100)或丙戊酸钠(n = 100),丙戊酸钠的初始剂量为30 mg/kg/天。疗效定义为无癫痫发作间隔增加三倍。每月监测副作用。使用SPSS 29版进行数据分析,显著性阈值为p<0.05。

结果

左乙拉西坦组85%的儿童实现了癫痫控制,丙戊酸钠组为73%(p = 0.037)。左乙拉西坦组31%的儿童报告无副作用,丙戊酸钠组为10%(p = 0.012)。丙戊酸钠组有16名儿童(16.0%)体重增加,而左乙拉西坦组有5名儿童(5.0%)体重增加。其他副作用,包括肝毒性、皮疹、嗜睡、震颤和行为改变,两组之间相当。

结论

对于儿童癫痫的管理,左乙拉西坦似乎比丙戊酸钠更有效且耐受性更好。这些发现表明左乙拉西坦可被视为首选的一线单一疗法。然而,需要进一步的纵向研究来在更长的治疗期间验证这些结果。

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