左乙拉西坦对比丙戊酸治疗儿童癫痫有效性和安全性的Meta分析

Efficacy and safety of levetiracetam versus valproic acid in the treatment of pediatric epilepsy:a meta analysis

目的比较左乙拉西坦与丙戊酸治疗儿童癫痫的有效性与安全性,为临床用药提供循证参考。方法计算机检索中国知网、维普网、中国生物医学文献数据库、万方数据、PubMed、Embase、Cochrane Library,收集左乙拉西坦(试验组)对比丙戊酸(对照组)的随机对照试验(RCT),检索时限均为各数据库建库起至2021年10月1日。筛选文献、提取资料后,采用Cochrane系统评价员手册5.1.0推荐的偏倚风险评估工具对纳入文献质量进行评价;采用RevMan 5.3软件进行Meta分析、敏感性分析和发表偏倚分析。结果共纳入33项RCT,共计3116例患儿。Meta分析结果显示,试验组患儿的有效率显著高于对照组[RR=1.06,95%CI(1.02,1.11),P=0.003]。按不同疗程进行的亚组分析结果显示,治疗1、3个月时,两组患儿的有效率比较,差异均无统计学意义(P>0.05);治疗6个月时,试验组患儿的有效率显著高于对照组(P<0.05)。试验组患儿的不良反应总发生率显著低于对照组[RR=0.50,95%CI(0.41,0.61),P<0.00001];在具体不良反应中,试验组患儿的恶心呕吐发生率显著低于对照组(P<0.05),但两组患儿的皮疹、嗜睡、情绪异常、食欲不振、头晕头痛等发生率比较,差异均无统计学意义(P>0.05)。敏感性分析结果显示,所得结果稳定可靠。发表偏倚分析结果显示,本研究存在发表偏倚的可能性较小。结论左乙拉西坦和丙戊酸治疗儿童癫痫的短期疗效(1、3个月)相当,左乙拉西坦的长期疗效(6个月)更好;且左乙拉西坦在消化系统中的安全性较好。

OBJECTIVE To compare the efficacy and safety of levetiracetam versus valproic acid in the treatment of pediatric epilepsy,and to provide evidence-based reference.METHODS The databases including CNKI,VIP,China Biomedical Literature Database,Wanfang data,PubMed,Embase and Cochrane Library were searched for the RCTs about levetiracetam(trial group)and valproic acid(control group)were collected from the inception to October 1st,2021.After literature screening and data extraction,the quality of included literature was evaluated using the bias risk assessment tool recommended by Cochrane system evaluator manual 5.1.0 and RevMan 5.3 software were used for meta-analysis,sensitivity analysis and bias risk analysis.RESULTS A total of 33 RCTs were included,involving 3116 patients in total.The results of the meta-analysis showed that the effective rate of trial group was significantly higher than control group[RR=1.06,95%CI(1.02,1.11),P=0.003].The subgroup analysis according to different courses of treatment showed that there was no statistical significance in the effective rate between 2 groups after 1 and 3 months of treatment(P>0.05);after 6 months of treatment,the effective rate of trial group was significantly higher than that of control group(P<0.05).The incidence of adverse drug reaction in trial group was significantly lower than control group[RR=0.50,95%CI(0.41,0.61),P<0.00001];among specific adverse drug reactions,the incidence of nausea and vomiting in trial group was significantly lower than control group(P<0.05);but there was no statistical significance in the incidence of rash,drowsiness,abnormal mood,loss of appetite,dizziness or headache(P>0.05).Results of sensitivity analysis showed that study results were stable and reliable.Results of publication bias analysis showed that there was little possibility of publication bias in this study.CONCLUSIONS The short-term efficacy(1,3 months)of LEV is similar to that of VPA in the treatment of pediatric epilepsy,but long-term efficacy(6 months)of LEV is better than that of VPA;moreover,LEV shows better safety in digestive system.