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新型抗癫痫药物作为附加治疗成人耐药性部分发作性癫痫的临床疗效和安全性:随机安慰剂对照试验的荟萃分析。

Clinical efficacy and safety of the newer antiepileptic drugs as adjunctive treatment in adults with refractory partial-onset epilepsy: a meta-analysis of randomized placebo-controlled trials.

机构信息

School of Biomedical Sciences and Pharmacy, University of Newcastle, Australia.

出版信息

Epilepsy Res. 2013 Jan;103(1):31-44. doi: 10.1016/j.eplepsyres.2012.06.005. Epub 2012 Jul 8.

DOI:10.1016/j.eplepsyres.2012.06.005
PMID:22776828
Abstract

OBJECTIVE

To evaluate the clinical efficacy and safety of the newer antiepileptic drugs (AEDs), namely, Eslicarbazepine (ESL), Retigabine/Ezogabine (RTG), Carisbamate (CAR), Lacosamide (LAC), Brivaracetam (BRI) or Perampanel (PER) as adjunctive therapy for adults with partial-onset seizures (POS).

METHODS

A systematic review of Randomized placebo-controlled Trials (RCTs) of newer AEDs was conducted. Electronic databases and identified bibliographies were searched to retrieve RCTs. The primary outcomes were responder rates and withdrawal rates, adverse effects. Pooled effects of odds ratio (OR), risk ratio (RR) and risk differences (RD) were derived from meta-analysis implemented in Revmen 5.1.

RESULTS

In total, 15 RCTs were included. All the studies contained a baseline and treatment phase. The pooled OR of all newer AEDs vs placebo was 2.16 (95% CI: 1.82, 2.57) for responder rates, 1.54 (1.12, 2.10) for withdrawal rates, 1.67 (1.34, 2.08) for adverse effects. The indirect comparisons between individual newer AED and all other newer AEDs suggested the similar results in responder rates (ORs, BRI 1.79 [-1.50, 5.08], RTG 1.41 [0.49, 2.33]).

CONCLUSIONS

The pooled ORs suggested newer AEDs might be more effective than placebo while with higher incidence of adverse effects. The indirect comparisons suggested BRI, followed by RTG, might be more effective than all other newer AEDs, which could be confirmed by future clinical studies.

摘要

目的

评估新型抗癫痫药物(AEDs),即依佐加滨/瑞替加滨(RTG)、左乙拉西坦(LAC)、卡马西平(CAR)、拉科酰胺(LAC)、布瓦西坦(BRI)或吡仑帕奈(PER)作为成人部分发作性癫痫(POS)辅助治疗的临床疗效和安全性。

方法

系统检索了新型 AEDs 的随机安慰剂对照试验(RCT)。检索电子数据库和已确定的参考文献,以检索 RCT。主要结局指标为应答率和停药率、不良反应。采用 Revmen 5.1 进行荟萃分析,得出比值比(OR)、风险比(RR)和风险差(RD)的合并效应。

结果

共纳入 15 项 RCT。所有研究均包含基线期和治疗期。新型 AEDs 与安慰剂相比的总应答率的合并 OR 为 2.16(95%CI:1.82,2.57),停药率的合并 OR 为 1.54(1.12,2.10),不良反应的合并 OR 为 1.67(1.34,2.08)。个别新型 AED 与所有其他新型 AED 之间的间接比较表明,应答率的结果相似(ORs,BRI 1.79 [-1.50,5.08],RTG 1.41 [0.49,2.33])。

结论

新型 AEDs 的汇总 OR 表明,与安慰剂相比,新型 AEDs 可能更有效,但其不良反应发生率更高。间接比较表明,BRI 可能比所有其他新型 AED 更有效,这可以通过未来的临床研究来证实。

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