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奥卡西平与卡马西平单药治疗部分性发作的对比

Oxcarbazepine versus carbamazepine monotherapy for partial onset seizures.

作者信息

Koch Marcus W, Polman Susanne Kl

机构信息

Department of Neurology, University Medical Center Groningen, Postbus 30.001, Groningen, Netherlands, 9700RB.

出版信息

Cochrane Database Syst Rev. 2009 Oct 7(4):CD006453. doi: 10.1002/14651858.CD006453.pub2.

Abstract

BACKGROUND

Partial onset seizures are often treated with the standard antiepileptic drug carbamazepine. Oxcarbazepine is a newer antiepileptic drug related to carbamazepine that is claimed to be better tolerated.

OBJECTIVES

To compare efficacy and tolerability of carbamazepine and oxcarbazepine monotherapy for partial onset seizures.

SEARCH STRATEGY

We searched the Cochrane Epilepsy Group Specialised Register (4 August 2009), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library issue 3, 2009), MEDLINE (January 1966 to May 2008), reference lists of relevant articles and conference proceedings. We also contacted manufacturers and researchers in the field for published or unpublished data.

SELECTION CRITERIA

Blinded and unblinded randomised controlled trials of carbamazepine versus oxcarbazepine monotherapy for partial onset seizures.

DATA COLLECTION AND ANALYSIS

Both authors independently assessed trial quality, according to the guidelines in the Cochrane Reviewer's Handbook, and extracted information about study population, type of intervention, outcome measures and study design. All analyses in this review are by intention-to-treat. We tested for statistical heterogeneity among the identified studies using the chi-squared test.

MAIN RESULTS

Three trials (723 participants) were included. Only one trial used adequate outcome measures of efficacy; therefore, the results pertaining to efficacy are based on a single trial, whereas the results pertaining to adverse events are based on all three included trials. There was no overall difference in time to treatment withdrawal between the two drugs (hazard ratio (HR) of oxcarbazepine (OXC) versus carbamazepine (CBZ): 1.04, 95% confidence interval (CI) 0.78 to 1.39). Further analyses showed no significant difference in treatment withdrawal for unacceptable side effects (HR of OXC versus CBZ: 0.85, 95% CI 0.59 to 1.24) and in treatment withdrawal for inadequate seizure control (HR of OXC versus CBZ: 1.33, 95% CI 0.82 to 2.15). Oxcarbazepine and carbamazepine appeared to be similarly effective and well tolerated although the confidence intervals around estimates were wide and do not rule out the possibility of important differences existing. Significantly fewer patients on carbamazepine treatment developed nausea or vomiting, or both (odds ratio of OXC versus CBZ: 3.15, 95% CI 1.39 to 7.14).

AUTHORS' CONCLUSIONS: Oxcarbazepine and carbamazepine appear to be similarly effective and well tolerated. However, the possibility of important differences existing between these drugs cannot be ruled out.

摘要

背景

部分性发作癫痫常使用标准抗癫痫药物卡马西平进行治疗。奥卡西平是一种与卡马西平相关的新型抗癫痫药物,据称耐受性更好。

目的

比较卡马西平和奥卡西平单药治疗部分性发作癫痫的疗效和耐受性。

检索策略

我们检索了Cochrane癫痫专业组专门注册库(2009年8月4日)、Cochrane对照试验中心注册库(CENTRAL,Cochrane图书馆2009年第3期)、MEDLINE(1966年1月至2008年5月)、相关文章的参考文献列表和会议论文集。我们还联系了该领域的制造商和研究人员以获取已发表或未发表的数据。

选择标准

卡马西平与奥卡西平单药治疗部分性发作癫痫的盲法和非盲法随机对照试验。

数据收集与分析

两位作者均根据Cochrane系统评价员手册中的指南独立评估试验质量,并提取有关研究人群、干预类型、结局指标和研究设计的信息。本综述中的所有分析均采用意向性分析。我们使用卡方检验对纳入研究中的统计学异质性进行检验。

主要结果

纳入了3项试验(723名参与者)。只有1项试验使用了充分的疗效结局指标;因此,有关疗效的结果基于单项试验,而有关不良事件的结果基于所有3项纳入试验。两种药物在治疗撤药时间上没有总体差异(奥卡西平(OXC)与卡马西平(CBZ)的风险比(HR):1.04,95%置信区间(CI)0.78至1.39)。进一步分析显示,因不可接受的副作用导致的治疗撤药(奥卡西平与卡马西平的HR:0.85,95%CI 0.59至1.24)以及因癫痫控制不佳导致的治疗撤药(奥卡西平与卡马西平的HR:1.33,95%CI 0.82至2.15)均无显著差异。奥卡西平和卡马西平似乎疗效相似且耐受性良好,尽管估计值周围的置信区间较宽,不能排除存在重要差异的可能性。接受卡马西平治疗的患者出现恶心或呕吐或两者皆有的情况明显较少(奥卡西平与卡马西平的比值比:3.15,95%CI 1.39至7.14)。

作者结论

奥卡西平和卡马西平似乎疗效相似且耐受性良好。然而,不能排除这些药物之间存在重要差异的可能性。

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