摘要
目的评价醋酸艾司利卡西平(ESL)添加治疗成人难治性癫痫部分性发作的有效性与安全性。方法计算机检索Cochrane图书馆、Pub Med、EMBase、OVID、CNKI、万方等电子数据库,筛选ESL治疗成人难治性癫痫部分性发作的所有随机对照试验(RCT),由2位独立的研究者提取资料并进行质量评价后,采用Rev Man 5.3软件进行Meta分析。结果共纳入5篇RCT,1 796例患者。ESL组的癫痫完全不发作率、发作频率减少≥50%的患者百分率高于安慰剂组〔RR=2.94,95%CI(1.76,4.89),P<0.000 1;RR=1.77,95%CI(1.50,2.07),P<0.000 01〕;ESL主要不良反应有头晕、嗜睡、头痛、呕吐等。但与安慰剂组相比,ESL 3个剂量组总的不良反应发生率均高于安慰剂组(P<0.05)。结论每日800 mg或1 200 mg ESL添加治疗成人难治性癫痫能有效减少癫痫发作频率,不良反应可耐受。受文献数量、质量及疗程限制,上述结论还需更多多中心临床试验进一步验证。
Objective To assess the efficacy and safety of eslicarbazepine acetate（ ESL） as add- on treatment of adults with refractory partial- onset seizures. Methods All randomized controlled trials（ RCTs） about ESL treatment of adults with refractory partial- onset seizures were searched and retrieved from the databases of Pub Med,Embase,Cochrane Library,Medline,OVID,CNKI and Wanfang. Two researchers independently extracted data and assessed the methodological quality.Meta- analysis was conducted by Rev Man5. 2 software. Results Five studies involving 1 796 patients were included. Compared with placebo group,the seizure- free rate and the proportion of patients who had ≥50% reduction of seizure frequency were higher in the treatment group with ESL as add- on treatment 〔RR = 2. 94,95% CI（ 1. 76,4. 89）,P〈0. 000 1; RR = 1. 77,95% CI（ 1. 50,2. 07）,P〈0. 000 01〕; common adverse reactions（ ADR） of ESL were dizziness,somnolence,headache,vomiting etc. But the total rate of ADR of the three ESL groups of different doses was higher than placebo group（ P〈0. 05）.Conclusion Once- daily treatment with ESL 800 or 1200 mg is effective and generally well tolerated in adult patients with refractory partial- onset seizures. However,due to the limited quantity,quality and follow- up of the included studies,more multicenter randomized controlled trials are needed to verify the results.
出处
《中国全科医学》
CAS
CSCD
北大核心
2016年第8期946-950,共5页
Chinese General Practice
作者简介
通信作者：黄毅岚，646000四川省泸州市，泸州医学院附属医院；E—mail：hyl360131@163．com
