左乙拉西坦辅助治疗难治性局灶性癫痫的系统评价

Systematic Review of Levetiracetam as Adjunctive Therapy for Refractory Focal Epilepsy

目的 评价左乙拉西坦(LEV)辅助治疗难治性局灶性癫痫的疗效与安全性。方法 检索中英文数据库中有关左乙拉西坦辅助治疗难治性局灶性癫痫的临床随机对照试验(RCT),检索时限为建库至2023年3月;2名研究者对纳入文献进行严格质量评价;采用RevMan 5.3软件对各效应指标进行Meta分析。结果 纳入7篇临床随机、双盲、安慰剂试验。共纳入病例1 223例,左乙拉西坦组647例,安慰剂组576例。Meta分析结果显示:相比安慰剂组,观察周期内的左乙拉西坦组难治性局灶性癫痫发作平均次数每周减少≥50%应答率(OR=3.44,95%CI:2.62~4.52,P<0.05)和≥75%应答率(OR=4.89,95%CI:2.69~8.88,P<0.05)差异有统计学意义,2组药物相关的严重不良反应(RR=1.93,95%CI:1.06~3.53,P<0.05)、困倦(嗜睡)(RR=1.46,95%CI:1.08~1.99,P <0.05)、肌肉骨骼和结膜组织并发症(RR=1.93,95%CI:1.15~3.25,P<0.05)的发生率差异有统计学意义,头晕、头痛、胃肠不适(如恶心、腹痛、腹泻)、感染(侵袭)、血生化异常、心电图异常、复视、耳鸣、皮肤瘙痒、鼻咽炎、记忆缺陷的发生率差异无统计学意义(P>0.05)。结论 左乙拉西坦辅助治疗难治性局灶性癫痫具有巩固疗效、减少癫痫发作次数的作用。

Objective To evaluate the efficacy and safety of levetiracetam(LEV)in the adjuvant treatment of refractory focal epilepsy.Methods Randomized controlled trials(RCT)on the adjuvant treatment of refractory focal epilepsy with levetiracetam were searched from Chinese and English databases.The search time was from database establishment to March 2023.Two researchers evaluated the quality of the included literature strictly.Meta-analysis of each effect index was performed by RevMan 5.3 software.Results Sever clinical randomized,double-blind,placebo trials were included.There were 1223 cases,including 647 in the levetiracetam group and 576 in the placebo group.Meta-analysis showed that the mean number of refractory focal seizures per week in the levetiacetam group was reduced by≥50%response rate(OR=3.44,95%CI:2.62-4.52,P<0.05)and≥75%response rate(OR=4.89,95%CI:2.69-8.88,P<0.05),There were statistically different between the two groups.There were statistical differences in the drug-related serious adverse reactions(RR=1.93,95%CI:1.06-3.53,P<0.05),drowsiness(RR=1.46,95%CI:1.08-1.99,P<0.05),musculoskeletal and conjunctival complications(RR=1.93,95%CI:1.15-3.25,P<0.05),but there were no statistical differences in the incidence of dizziness,headache,gastrointestinal discomfort(such as nausea,abdominal pain,diarrhea),infection(invasion),blood biochemical abnormalities,electrocardiogram abnormalities,diplopia,tinnitus,pruritus,nasopharyngitis,and memory deficit(P>0.05).Conclusion The adjuvant treatment of levetiracetam in refractory focal epilepsy has a consolidation effect and a significant effect of reducing the number of seizures.