Efficacy of Levetiracetam in Patients With Pediatric Epilepsy: A Systematic Review and Meta-Analysis.

However, its comparative efficacy relative to established antiseizure medications (ASMs) in children remains uncertain.

然而，与已建立的抗癫痫药物（ASMs）相比，其在儿童中的相对疗效仍不确定。

We conducted a systematic reviewand meta-analysisof randomized controlled trials (RCTs) to evaluate LEV efficacy in pediatric epilepsies and compare outcomes vs placebo and active comparators.

我们进行了一项系统评价和荟萃分析，评估左乙拉西坦在儿童癫痫中的疗效，并与安慰剂和活性对照药物进行比较。

Methods

We systematically searched PubMed/MEDLINE and Embase (2000-6 August 2025) for RCTs enrolling patients 16 years or younger with epilepsy and reporting seizure freedom and/or ≥50% responder rate.

我们系统地检索了PubMed/MEDLINE和Embase（2000年1月6日至2025年8月），以寻找纳入16岁或以下癫痫患者的随机对照试验，并报告了无癫痫发作和/或≥50%的反应者率。

Trials including both pediatric and adult patients were eligible if pediatric participants were represented.

如果儿科患者得到代表，则包括儿科和成年患者的试验都是符合条件的。

Comparisons included LEV vs placebo or active ASMs as monotherapy or adjunctive therapy.

比较包括LEV与安慰剂或活性抗癫痫药物（ASMs）作为单药治疗或辅助治疗的比较。

Primary outcomes were seizure freedom and responder rate at the trial's primary endpoint or, if not specified, longest reported follow-up.

主要结果是试验主要终点时的无癫痫发作和反应者率，或者如果没有指定，则为最长的随访报告。

We assessed risk of bias using Cochrane Risk of Bias 2.

我们使用Cochrane风险偏倚评估工具2评估偏倚风险。

We pooled risk differences (RDs) with 95% CIs using random-effects models, stratified by comparator and epilepsy subtype.

我们使用随机效应模型，根据对照组和癫痫亚型进行分层，汇总了风险差异（RDs）及其95%置信区间。

Results

We included 25 RCTs (4,070 participants): 23 contributed to pooled meta-analyses.

我们纳入了25项随机对照试验（RCTs），共4,070名参与者：其中23项对汇总的荟萃分析有贡献。

Across 25 trials, the mean age ranged from 0.4 to 39.3 years, reflecting pediatric-only and mixed-age RCTs; 43.8% were female.

在25项试验中，平均年龄范围从0.4岁到39.3岁，反映了仅限儿童和混合年龄的随机对照试验（RCTs）；43.8%为女性。

In placebo/no-therapy-controlled trials (mainly add-on studies), LEV was associated with higher seizure freedom (RD 11.0%; 95% CI 5.3%-16.7%) and responder rates (RD 24.3%; 95% CI 19.1%-29.4%).

在安慰剂/无治疗对照试验中（主要是附加研究），LEV与更高的癫痫发作自由率（RD 11.0%；95% 置信区间 5.3%-16.7%）和反应者率（RD 24.3%；95% 置信区间 19.1%-29.4%）相关。

In active-comparator-controlled trials (mainly monotherapy head-to-head studies), LEV showed no overall advantage vs active comparators for seizure freedom (RD -2.4%; 95% CI -5.6% to 0.7%) or responder rate (RD -7.4%; 95% CI -23.0% to 8.1%).

在活性对照药物试验中（主要是单药直接比较研究），与活性对照药物相比，LEV在癫痫发作自由（风险差异-2.4%；95%置信区间-5.6%至0.7%）或应答率（风险差异-7.4%；95%置信区间-23.0%至8.1%）方面没有显示出总体优势。

Fourteen trials were at high risk of bias.

有十四项试验存在高风险偏倚。

Sensitivity analyses confirmed benefit vs placebo but showed significant disadvantage vs active comparators in low risk-of-bias trials.

敏感性分析确认了与安慰剂相比的益处，但在低偏倚风险的试验中与活性对照相比显示出显著的劣势。

Findings in pediatric-only trials (16 RCTs; 1,380 participants) were consistent with the overall results.

仅在儿科试验中的发现（16项随机对照试验；1,380名参与者）与总体结果一致。

Discussion

LEV confers benefit vs placebo, mostly as adjunctive therapy, but does not consistently outperform established ASMs in pediatric epilepsies and may be inferior in some subgroups when higher-quality evidence is considered.

与安慰剂相比，LEV作为辅助治疗显示出优势，但在儿童癫痫治疗中并不总是一致地优于已建立的抗癫痫药物，当考虑更高质量的证据时，在某些亚组中可能表现较差。

Limitations include substantial heterogeneity, frequent high risk of bias, variable follow-up durations, publication bias, and limited pediatric-only comparative data.

局限性包括显著的异质性、频繁的高偏倚风险、随访时间不一、发表偏倚以及有限的仅限儿童的比较数据。