拉考沙胺作为添加治疗对局灶性癫痫的长期疗效和安全性:Meta分析

Long-term efficacy and safety of lacosamine as an adjuvant therapy for patients with partial-onset seizures: A Meta-analysis

目的评价拉考沙胺作为添加治疗对局灶性癫痫的长期疗效和安全性。方法计算机检索Pub Med、Em Base、The Cochrane Library、Clinicaltrial.gov、中国知网和万方数据库,纳入拉考沙胺作为添加治疗对局灶性癫痫的长期疗效和安全性的前瞻性研究,用Stata 12.1软件对50%应答率、无癫痫发作率、每28 d癫痫发作频率变化和安全性进行Meta分析。结果共纳入10篇研究,共2106个患者。有效性方面,1年50%应答率为52%,3年50%应答率为60%,1年无癫痫发作率为23%,3年无癫痫发作率为30%,每28 d局灶性癫痫发作频率变化百分比为-49.99%。安全性方面,因药物不良反应退出研究的人数百分率为10%,拉考沙胺相关严重药物不良反应发生率为7%,头晕、复视和恶心发生率分别为36%,14%和13%。结论LCM作为添加治疗对局灶性癫痫长期疗效良好,能够有效控制患者的癫痫发作频率,同时还有良好的安全性。

Objective To assess long-term efficacy and safety of lacosamine as an adjuvant therapy for patients with partial-onset seizures.Methods PubMed,EmBase,The Cochrane Library,Clinicaltrial.gov,CNKI and WANFANG data were searched for relevant studies.Long-term prospective clinical trials treating partial-onset seizures with adjunctive locasamide were included.Meta-analysis of 50%responder rate,seizures-free rate,reduction in seizure frequency per 28 days and safety issue was performed with Stata 12.1.Results Ten studies were included in this review.The 50%responder rate for 1 year and 3 year were 52%and 60%,respectively.The seizures-free rate for 1 year and3 year were 23%and 30%,respectively.Median percent reduction in seizure frequency per 28 days was-49.99%.The incidence of adverse event leading to discontinuation was 10%.The incidence of severe adverse event related to lacosamide was 7%.The incidences of dizziness,diplopia and nausea were 36%,14%and 13%,respectively.Conclusion Long-term adjunctive lacosamide treatment was effective in reducing seizure frequency and well tolerated.