Cao Yaohua, He Xin, Zhao Lina, He Yuwen, Wang Sen, Zhang Tiantian, Jiang Jie
College of Pharmacy, Jinan University, Guangzhou, 510632, China.
State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Taipa, Macau SAR, 999078, China.
Epilepsy Res. 2019 Jul;153:40-48. doi: 10.1016/j.eplepsyres.2019.04.001. Epub 2019 Apr 3.
To assess the efficacy and safety of levetiracetam (LEV) as adjunctive treatment in children (0-18 years) with focal-onset seizures (FOS) with a larger dataset.
A pooled analysis would be performed for prospective clinical trials and a meta-analysis for controlled studies. Retrospectives studies were also summarized using descriptive statistics.
Thirty-one articles (1763 patients) were identified, eighteen prospective self-controlled studies and thirteen retrospective studies. LEV was more effective than placebo, the pooled risk ratios (RRs) and 95% confidence intervals (CIs) for the 50% responder rate, seizure freedom rate and the median percentage reduction rate were 1.98 (1.49-2.63), 5.12 (2.09-12.51) and 3.19 (2.37-4.30), respectively. The overall response rates (ORRs) and 95% CIs were 56% (52%-60%), 14% (9%-19%) and 55% (31%-79%), respectively. For safety assessment, the pooled RRs and 95% CIs for the at least one treatment-emergent adverse events (TEAE) rate and at least one adverse drug reactions related (ADR-related) TEAE rate were 1.03 (0.94-1.13) and 1.45 (1.13-1.86) between two group. The ORRs and 95% CIs were 74% (54%-94%) and 48% (40%-55%). The adverse events significantly associated with LEV were somnolence 2.26 (95% CI 1.30-3.93) and hostility 2.33 (95% CI 1.15-4.70). The most frequency adverse events were pyrexia, headache, nervousness, upper respiratory tract and somnolence. The RRs for withdrawal rate or the ADR-related withdrawal rate were 0.77 (95% CI 0.44-1.38) and 0.91 (0.42-1.98), the ORRs were 17% (5%-28%) and 6% (4%-8%).
The meta-analysis suggested that add-on LEV can significantly reduce seizure frequency and fairly tolerated compared to placebo.
采用更大的数据集评估左乙拉西坦（LEV）作为辅助治疗药物用于0至18岁局灶性发作（FOS）儿童的疗效和安全性。
将对前瞻性临床试验进行汇总分析，对对照研究进行荟萃分析。还使用描述性统计对回顾性研究进行总结。
共纳入31篇文章（1763例患者），其中18篇前瞻性自身对照研究和13篇回顾性研究。LEV比安慰剂更有效，50%缓解率、无癫痫发作率和中位数降低率的汇总风险比（RRs）及95%置信区间（CIs）分别为1.98（1.49 - 2.63）、5.12（2.09 - 12.51）和3.19（2.37 - 4.30）。总体缓解率（ORRs）及95% CIs分别为56%（52% - 60%）、14%（9% - 19%）和55%（31% - 79%）。安全性评估方面，两组间至少发生一次治疗中出现的不良事件（TEAE）率及至少一次与药物不良反应相关（ADR相关）的TEAE率的汇总RRs及95% CIs分别为1.03（0.94 - 1.13）和1.45（1.13 - 1.86）。ORRs及95% CIs分别为74%（54% - 94%）和48%（40% - 55%）。与LEV显著相关的不良事件为嗜睡2.26（95% CI 1.30 - 3.93）和敌意2.33（95% CI 1.15 - 4.70）。最常见的不良事件为发热、头痛、紧张、上呼吸道感染和嗜睡。撤药率或与ADR相关的撤药率的RRs分别为0.77（95% CI 0.44 - 1.38）和0.91（0.42 - 1.98），ORRs分别为17%（5% - 28%）和6%（4% - 8%）。
荟萃分析表明，与安慰剂相比，添加LEV可显著降低癫痫发作频率，且耐受性良好。
