Intervention Review

Oxcarbazepine add-on for drug-resistant partial epilepsy

  1. Sergio M Castillo1,*,
  2. Dieter B Schmidt2,
  3. Sarah White3,
  4. Arif Shukralla4

Editorial Group: Cochrane Epilepsy Group

Published Online: 24 JUL 2000

Assessed as up-to-date: 26 MAR 2006

DOI: 10.1002/14651858.CD002028

How to Cite

Castillo SM, Schmidt DB, White S, Shukralla A. Oxcarbazepine add-on for drug-resistant partial epilepsy. Cochrane Database of Systematic Reviews 2000, Issue 3. Art. No.: CD002028. DOI: 10.1002/14651858.CD002028.

Author Information

  1. 1

    Hospital del Salvador, Servicio de Neurologia, Santiago, Chile

  2. 2

    Epilepsy Research Group, Berlin, Germany

  3. 3

    St Georges, University of London, Research Resource Unit, Department of Mental Health, London, UK

  4. 4

    Clinical Sciences Centre for Research and Education, University Department of Neurological Science, Liverpool, UK

*Sergio M Castillo, Servicio de Neurologia, Hospital del Salvador, Salvador 364, Providencia, Santiago, Chile. castillochile@yahoo.com.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 24 JUL 2000

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

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 summarize the current evidence regarding oxcarbazepine when used as an add-on treatment for drug-resistant partial epilepsy.

Objectives

To evaluate the effects of oxcarbazepine when used as an add-on treatment for drug-resistant partial epilepsy.

Search methods

We searched the Cochrane Epilepsy Group's Specialized Register (28 March 2006), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2006), MEDLINE (1966 to March 2006). No language restrictions were imposed. We checked the reference lists of retrieved studies for additional reports of relevant studies. We also contacted Novartis (manufacturers of oxcarbazepine) and experts in the field.

Selection criteria

Randomized, placebo-controlled, double-blinded, add-on trials of oxcarbazepine in patients with drug-resistant partial epilepsy.

Data collection and analysis

Two review authors 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.

Main results

Two trials were included representing 961 randomized patients.
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.

Authors' 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.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Oxcarbazepine add-on for drug-resistant partial epilepsy

Oxcarbazepine is effective as a short-term combination treatment for partial epilepsy.

Epilepsy is a disorder where recurrent seizures are caused by abnormal electrical discharges from the brain. Oxcarbazepine is an antiepileptic drug which can be used as an add-on treatment for people with drug-resistant partial epilepsy who are resistant to other antiepileptic drugs. The review of trials found that oxcarbazepine used in this way can reduce seizure frequency in the short-term for adults and children. The review did not include people with generalized epilepsy or look at the long-term effects of oxcarbazepine.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

Oxcarbazepine作為添加療法來治療藥物難治的局部發作型癲癇

多數癲癇患者的預後良好,使用單一抗癲癇藥物就可以有效控制其癲癇發作,但是還有將近30%的人發展成為藥物難治的癲癇,尤其是局部發作型的患者。在本次回顧中,我們總結了Oxcarbazepine作為藥物難治的局部發作型癲癇的添加療法的臨床證據。

目標

評估Oxcarbazepine作為添加療法來治療藥物難治的局部發作型癲癇的成果。

搜尋策略

我們搜尋了Cochrane Epilepsy Group's Specialized Register(2006年3月28日)以及Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library,2006年第1期) 和MEDLINE(1966年 −2006年3月)。 沒有設定任何語言限制。我們檢視了所找出的試驗的參考文獻清單,以獲取額外的相關研究資料。我們也聯繫了Novartis(Oxcarbazepine的製造商)以及該領域的專家。

選擇標準

選擇比較添加Gabapentin或安慰劑來治療藥物難治的局部發作型癲癇患者的隨機雙盲對照試驗。

資料收集與分析

兩位回顧作者各自選擇收納試驗和摘錄數據。評估了下列治療成果:(a) 癲癇發作頻率降低50% 或以上;(b) 停止試驗用藥(不論任何原因);(c) 藥物不良反應。初步分析採用intentiontotreat方法。對每項治療成果評估了總體的odds ratios。

主要結論

總共收納了2個試驗,包括961位隨機挑選的受試者。相較於安慰劑,Oxcarbazepine在達成癲癇發作頻率降低50% 或以上的odds ratio(OR)與95% conficence interval(CIs)是2.96 (2.20, 4.00)。相較於安慰劑,停藥的OR與95% CIs為2.17 (1.59, 2.97)。相對於安慰劑,下列藥物不良反應的OR與99% CIs分別為:共濟失調2.93 (1.72, 4.99);頭暈 3.05 (1.99, 4.67);疲勞1.80 (1.02, 3.19);噁心2.88 (1.77, 4.69);嗜睡2.55 (1.84, 3.55);複視4.32 (2.65, 7.04) 均顯著和Oxcarbazepine相關。

作者結論

Oxcarbazepine作為添加療法來治療藥物難治的局部發作型癲癇的成人或兒童患者時確有其療效。但因本回顧中的臨床試驗,治療期間都相對較短,所以無法提供長期療效的證據。上述的結果也不能外推到單一藥物療法或患有其他癲癇類型的病人。

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

Oxcarbazepine作為短期治療局部發作型癲癇患者的合併藥物療法是有效的。癲癇是一種由於大腦放電異常引起的重覆發作的疾病。Oxcarbazepine可作為添加療法來治療藥物難治的局部發作型癲癇患者。本回顧發現,以Oxcarbazepine作為短期使用的添加療法可以降低成人和兒童的癲癇發作頻率。本回顧沒有包括全盤發作型癲癇的患者,也未研究Oxcarbazepine的長期治療成果。