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本文引用的文献

1
Influence of major antiepileptic drugs on attention, reaction time, and speed of information processing: results from a randomized, double-blind, placebo-controlled withdrawal study of seizure-free epilepsy patients receiving monotherapy.主要抗癫痫药物对注意力、反应时间及信息处理速度的影响:来自一项针对接受单药治疗且无癫痫发作的癫痫患者的随机、双盲、安慰剂对照撤药研究的结果
Epilepsia. 2006 Dec;47(12):2038-45. doi: 10.1111/j.1528-1167.2006.00805.x.
2
Efficacy of carbamazepine and valproate as monotherapy for early epilepsy and single seizures.卡马西平和丙戊酸盐作为早期癫痫和单次发作单药治疗的疗效。
Neurology. 2006 Nov 28;67(10):1872-5. doi: 10.1212/01.wnl.0000244421.73986.09.
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Modulation of serum concentrations of melatonin by carbamazepine and valproate.卡马西平和丙戊酸盐对血清褪黑素浓度的调节作用。
Indian J Physiol Pharmacol. 2006 Jan-Mar;50(1):79-82.
4
Early and persistent increase in serum lipoprotein (a) concentrations in epileptic children treated with carbamazepine and sodium valproate monotherapy.接受卡马西平和丙戊酸钠单药治疗的癫痫儿童血清脂蛋白(a)浓度早期且持续升高。
Epilepsy Res. 2006 Aug;70(2-3):211-7. doi: 10.1016/j.eplepsyres.2006.05.002. Epub 2006 Jun 15.
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The LAM-SAFE Study: lamotrigine versus carbamazepine or valproic acid in newly diagnosed focal and generalised epilepsies in adolescents and adults.拉莫三嗪与卡马西平或丙戊酸治疗青少年及成人新诊断局灶性和全身性癫痫的LAM-SAFE研究
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Considerations on designing clinical trials to evaluate the place of new antiepileptic drugs in the treatment of newly diagnosed and chronic patients with epilepsy.关于设计临床试验以评估新型抗癫痫药物在新诊断和慢性癫痫患者治疗中的地位的思考。
Epilepsia. 1998 Jul;39(7):799-803. doi: 10.1111/j.1528-1157.1998.tb01167.x.
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BMJ. 1996 Jul 6;313(7048):36-9. doi: 10.1136/bmj.313.7048.36.
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Randomised comparative monotherapy trial of phenobarbitone, phenytoin, carbamazepine, or sodium valproate for newly diagnosed childhood epilepsy.苯巴比妥、苯妥英、卡马西平或丙戊酸钠用于新诊断儿童癫痫的随机对照单药治疗试验。
Lancet. 1996 Mar 16;347(9003):709-13. doi: 10.1016/s0140-6736(96)90074-4.
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卡马西平与丙戊酸单药治疗癫痫的比较。

Carbamazepine versus valproate monotherapy for epilepsy.

作者信息

Marson A G, Williamson P R, Hutton J L, Clough H E, Chadwick D W

机构信息

University Department of Neurological Science, Room 2.30 - Clinical Science Centre for Research & Education, Lower Lane, Liverpool, Merseyside, UK, L9 7LJ.

出版信息

Cochrane Database Syst Rev. 2000;2000(3):CD001030. doi: 10.1002/14651858.CD001030.

DOI:10.1002/14651858.CD001030
PMID:10908558
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7032647/
Abstract

BACKGROUND

Carbamazepine and valproate are drugs of first choice for epilepsy. Despite the lack of hard evidence from individual randomized controlled trials, there is strong clinical belief that valproate is the drug of choice for generalized epilepsies and carbamazepine for partial epilepsies.

OBJECTIVES

To overview the best evidence comparing carbamazepine and valproate monotherapy

SEARCH STRATEGY

Our search strategy included: (a) MEDLINE 1966-99, (b) The Cochrane Library 1999 issue 4, (c) The trial register of the Cochrane Epilepsy Group (d) the pharmaceutical industry.

SELECTION CRITERIA

Randomized controlled trials comparing carbamazepine and valproate monotherapy for epilepsy.

DATA COLLECTION AND ANALYSIS

This was an individual patient data review. Outcome measures were time to withdrawal of allocated treatment, time to 12 month remission, and time to first seizure post randomization. Data were analysed using the stratified Logrank test with results expressed as hazard ratios (HR) (95% CI), where HR>1 indicates an event is more likely on valproate. A test for an interaction between treatment and epilepsy type (partial versus generalized) was also undertaken.

MAIN RESULTS

Results Data were available for 1265 patients from five trials, representing 85% of the patients recruited into the eight trials that met our inclusion criteria. The main overall results (HR 95% CI) were: Time to treatment withdrawal 0.97 (0.79-1.18), 12 month remission 0.87 (0.74-1.02), first seizure 1.09 (0.96-1.25) suggesting no overall difference for these outcomes. The test for an interaction between treatment and epilepsy type was non significant for time to treatment withdrawal and 12 month remission, but significant for time to first seizure. The age distribution of adults classified as having a generalized epilepsy indicate that significant numbers of patients may have had their epilepsy misclassified.

REVIEWER'S CONCLUSIONS: We have found some evidence to support the policy of using carbamazepine as the first treatment of choice in partial epilepsies, but no evidence to support the choice of valproate in generalized epilepsies, but confidence intervals are too wide to confirm equivalence. Misclassification of patients may have confounded our results, and has important implications for the design and conduct of future trials.

摘要

背景

卡马西平和丙戊酸盐是癫痫的首选药物。尽管缺乏来自个体随机对照试验的确凿证据,但临床上普遍认为丙戊酸盐是全身性癫痫的首选药物,而卡马西平是部分性癫痫的首选药物。

目的

综述比较卡马西平和丙戊酸盐单药治疗的最佳证据。

检索策略

我们的检索策略包括:(a)1966 - 1999年的MEDLINE,(b)1999年第4期的《 Cochr ane图书馆》,(c) Cochr ane癫痫研究组的试验注册库,(d)制药行业。

入选标准

比较卡马西平和丙戊酸盐单药治疗癫痫的随机对照试验。

数据收集与分析

这是一项个体患者数据回顾。观察指标为分配治疗的撤药时间、12个月缓解时间和随机分组后首次发作时间。数据采用分层对数秩检验进行分析,结果以风险比(HR)(95%可信区间)表示,其中HR>1表明丙戊酸盐治疗时事件更易发生。还进行了治疗与癫痫类型(部分性与全身性)之间相互作用的检验。

主要结果

五项试验的1265例患者有数据可用,占符合我们纳入标准的八项试验招募患者的85%。主要总体结果(HR 95%可信区间)为:治疗撤药时间0.97(0.79 - 1.18),12个月缓解时间0.87(0.74 - 1.02),首次发作时间1.09(0.96 - 1.25),表明这些结果无总体差异。治疗与癫痫类型之间相互作用的检验在治疗撤药时间和12个月缓解时间方面无显著性,但在首次发作时间方面有显著性。被归类为全身性癫痫的成人年龄分布表明,大量患者的癫痫分类可能有误。

综述作者结论

我们发现了一些证据支持将卡马西平作为部分性癫痫的首选初始治疗药物的策略,但没有证据支持在全身性癫痫中选择丙戊酸盐,不过可信区间过宽无法确认等效性。患者分类错误可能混淆了我们的结果,对未来试验的设计和实施具有重要意义。