Castillo S, Schmidt D B, White S
University Department of Neurological Science, 2nd floor - Clinical Science Centre for Research & Education, Lower Lane, Liverpool, Merseyside, UK, L9 7LJ.
Cochrane Database Syst Rev. 2000(3):CD002028. doi: 10.1002/14651858.CD002028.
Most people with epilepsy have a good prognosis and their seizures can be well controlled with the use of a single antiepileptic drug, but up to 30 % develop refractory epilepsy, especially those with partial seizures. In this review we summarise the current evidence regarding oxcarbazepine when used as an add-on treatment for drug-resistant partial epilepsy.
To evaluate the effects of oxcarbazepine when used as an add-on treatment for drug-resistant partial epilepsy.
We searched the Cochrane Epilepsy Group's trials register, the Cochrane Controlled Trials Register (Cochrane Library Issue 1, 2000), MEDLINE (January 1966 to December 1999) and reference lists of articles. We also contacted Novartis (manufacturers of oxcarbazepine) and experts in the field.
Randomized, placebo-controlled, double-blind, add-on trials of oxcarbazepine in patients with drug-resistant partial epilepsy.
Two reviewers independently assessed trials for inclusion and extracted the relevant data. The following outcomes were assessed : (a) 50 % or greater reduction in seizure frequency; (b) treatment withdrawal (any reason); (c) side effects. Primary analyses were intention to treat. Summary odds ratios were estimated for each outcome.
Overall Odds Ratio (OR) (95 % Confidence Interval (CIs)) for 50 % or greater reduction in seizure frequency compared to placebo 2.96 (2.20,4.00). Treatment withdrawal OR (95 % CIs) compared to placebo 2.17 (1.59,2.97). Side effects: OR (99 % CIs) compared to placebo, ataxia 2.93(1.72,4.99); dizziness 3.05 (1.99, 4. 67); fatigue 1.80 (1.02, 3.19); nausea 2.88 (1.77, 4.69); somnolence 2.55 (1.84, 3.55); diplopia 4.32 (2.65, 7.04), were significantly associated with oxcarbazepine.
REVIEWERS' CONCLUSIONS: Oxcarbazepine has efficacy as an add-on treatment in patients with drug-resistant partial epilepsy, both in adults and children. However, trials reviewed were of relatively short duration, and provide no evidence about the long term effects of oxcarbazepine. Results cannot be extrapolated to monotherapy or to patients with other epilepsy types.
大多数癫痫患者预后良好,使用单一抗癫痫药物即可很好地控制癫痫发作,但高达30%的患者会发展为难治性癫痫,尤其是那些患有部分性发作的患者。在本综述中,我们总结了目前关于奥卡西平作为耐药性部分性癫痫附加治疗药物的证据。
评估奥卡西平作为耐药性部分性癫痫附加治疗药物的疗效。
我们检索了Cochrane癫痫研究组的试验注册库、Cochrane对照试验注册库(Cochrane图书馆2000年第1期)、MEDLINE(1966年1月至1999年12月)以及文章的参考文献列表。我们还联系了诺华公司(奥卡西平的制造商)和该领域的专家。
奥卡西平用于耐药性部分性癫痫患者的随机、安慰剂对照、双盲、附加试验。
两名评价者独立评估试验是否纳入并提取相关数据。评估了以下结局:(a)癫痫发作频率降低50%或更多;(b)因任何原因停药;(c)副作用。主要分析采用意向性分析。对每个结局估计汇总比值比。
与安慰剂相比,癫痫发作频率降低50%或更多的总体比值比(OR)(95%置信区间(CI))为2.96(2.20,4.00)。与安慰剂相比,停药的OR(95%CI)为2.17(1.59,2.97)。副作用:与安慰剂相比,OR(99%CI),共济失调为2.93(1.72,4.99);头晕为3.05(1.99,4.67);疲劳为1.80(1.02,3.19);恶心为2.88(1.77,4.69);嗜睡为2.55(1.84,3.55);复视为4.32(2.65,7.04),均与奥卡西平显著相关。
奥卡西平作为附加治疗药物对耐药性部分性癫痫患者(包括成人和儿童)有效。然而,所综述的试验持续时间相对较短,且未提供关于奥卡西平长期疗效的证据。结果不能外推至单药治疗或其他癫痫类型的患者。