Marson A G, Williamson P R, Hutton J L, Clough H E, Chadwick D W
University Department of Neurological Science, Room 2.30 - Clinical Science Centre for Research & Education, Lower Lane, Liverpool, Merseyside, UK, L9 7LJ.
Cochrane Database Syst Rev. 2000;2000(3):CD001030. doi: 10.1002/14651858.CD001030.
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.
To overview the best evidence comparing carbamazepine and valproate monotherapy
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.
Randomized controlled trials comparing carbamazepine and valproate monotherapy for epilepsy.
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.
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.
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。
综述比较卡马西平和丙戊酸盐单药治疗的最佳证据。
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。
比较卡马西平和丙戊酸盐单药治疗癫痫的随机对照试验。
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。
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。
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。