Marson A G, Kadir Z A, Hutton J L, 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(3):CD001415. doi: 10.1002/14651858.CD001415.
The majority of patients with epilepsy have a good prognosis and their seizures are well controlled by 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 a new antiepileptic drug, gabapentin, when used as an add-on treatment for drug-resistant partial epilepsy.
To evaluate the efficacy and tolerability of gabapentin when used as an add-on treatment for patients with drug-resistant partial epilepsy.
We searched the Cochrane Epilepsy Group's trial register, the Cochrane Controlled Trials Register (The Cochrane Library Issue 1, 2000). In addition, we contacted Parke Davis (manufacturers of gabapentin) and experts in the field to seek any ongoing studies or unpublished studies.
Randomized placebo controlled double blind add-on trials of gabapentin in patients with drug-resistant partial epilepsy.
Two reviewers independently selected 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. Sensitivity best and worst case analyses were also undertaken. Summary odds ratios were estimated for each outcome. Dose response was evaluated in regression models, and Number Needed to Treat (NNTs) were calculated for individual doses.
Five trials were included representing 997 randomized patients. Overall odds ratio (OR) (95% Confidence Interval (CI)) for 50% or greater reduction in seizure frequency compared to placebo was 1.93 (1.37 - 2.71). Dose regression analysis shows increasing efficacy with increasing dose, with 28.5% (21.5 - 36.7) of patients responding to 1800mg of gabapentin compared to placebo, NNT 6.7 (3.0 - 10.5). Treatment withdrawal OR (95% CI) compared to placebo 1.05 (0.68 - 1.61); Side effects: OR (99% CI) compared to placebo. Dizziness 2.22 (1.28 - 3. 85); fatigue 2.28 (1.15 - 4.52); somnolence 2.01 (1.24 - 3.28) were significantly associated with gabapentin.
REVIEWER'S CONCLUSIONS: Gabapentin has efficacy as an add-on treatment in patients with drug-resistant partial epilepsy. However, trials reviewed were of relatively short duration, and provide no evidence for the long term efficacy of gabapentin. Results cannot be extrapolated to monotherapy or patients with other epilepsy types.
大多数癫痫患者预后良好，其癫痫发作可通过单一抗癫痫药物得到有效控制，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，我们总结了关于一种新型抗癫痫药物加巴喷丁作为耐药性部分性癫痫附加治疗的现有证据。
评估加巴喷丁作为耐药性部分性癫痫患者附加治疗的疗效和耐受性。
我们检索了Cochrane癫痫组试验注册库、Cochrane对照试验注册库（《Cochrane图书馆》2000年第1期）。此外，我们联系了加巴喷丁的制造商帕克·戴维斯公司以及该领域的专家，以查找任何正在进行的研究或未发表的研究。
加巴喷丁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。
两名评价员独立选择纳入试验并提取相关数据。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治疗。还进行了敏感性最佳和最差情况分析。对每个结局估计了汇总比值比。在回归模型中评估剂量反应，并计算各剂量的需治疗人数（NNT）。
纳入了5项试验，共997例随机分组患者。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1.93（1.37 - 2.71）。剂量回归分析显示，随着剂量增加疗效增强，与安慰剂相比，1800mg加巴喷丁治疗的患者中有28.5%（21.5 - 36.7）有反应，NNT为6.7（3.0 - 10.5）。与安慰剂相比，停药OR（95%CI）为1.05（0.68 - 1.61）；副作用：与安慰剂相比的OR（99%CI）。头晕2.22（1.28 - 3.85）；疲劳2.28（1.15 - 4.52）；嗜睡2.01（1.24 - 3.28）与加巴喷丁显著相关。
加巴喷丁作为耐药性部分性癫痫患者的附加治疗具有疗效。然而，所综述的试验持续时间相对较短，未提供加巴喷丁长期疗效的证据。结果不能外推至单药治疗或其他癫痫类型的患者。
