French Jacqueline A, Kanner Andres M, Bautista Jocelyn, Abou-Khalil Bassel, Browne Thomas, Harden Cynthia L, Theodore William H, Bazil Carl, Stern John, Schachter Steven C, Bergen Donna, Hirtz Deborah, Montouris Georgia D, Nespeca Mark, Gidal Barry, Marks William J, Turk William R, Fischer James H, Bourgeois Blaise, Wilner Andrew, Faught R Edward, Sachdeo Rajesh C, Beydoun Ahmad, Glauser Tracy A
Neurological Institute, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, USA.
Epilepsia. 2004 May;45(5):401-9. doi: 10.1111/j.0013-9580.2004.06204.x.
To assess the evidence demonstrating efficacy, tolerability, and safety of seven new antiepileptic drugs [AEDs; gabapentin (GBP), lamotrigine (LTG), topiramate (TPM), tiagabine (TGB), oxcarbazepine (OXC), levetiracetam (LEV), and zonisamide (ZNS), reviewed in the order in which these agents received approval by the U.S. Food and Drug Administration] in the treatment of children and adults with newly diagnosed partial and generalized epilepsies.
A 23-member committee, including general neurologists, pediatric neurologists, epileptologists, and doctors in pharmacy, evaluated the available evidence based on a structured literature review including MEDLINE, Current Contents, and Cochrane Library for relevant articles from 1987 until September 2002, with selected manual searches up to 2003.
Evidence exists, either from comparative or dose-controlled trials, that GBP, LTG, TPM, and OXC have efficacy as monotherapy in newly diagnosed adolescents and adults with either partial or mixed seizure disorders. Evidence also shows that LTG is effective for newly diagnosed absence seizures in children. Evidence for effectiveness of the new AEDs in newly diagnosed patients with other generalized epilepsy syndromes is lacking.
The results of this evidence-based assessment provide guidelines for the prescription of AEDs for patients with newly diagnosed epilepsy and identify those seizure types and syndromes for which more evidence is necessary.
评估七种新型抗癫痫药物(AEDs;加巴喷丁[GBP]、拉莫三嗪[LTG]、托吡酯[TPM]、噻加宾[TGB]、奥卡西平[OXC]、左乙拉西坦[LEV]和唑尼沙胺[ZNS],按照这些药物获得美国食品药品监督管理局批准的顺序进行综述)治疗新诊断的部分性和全身性癫痫患儿及成人的疗效、耐受性和安全性证据。
一个由23名成员组成的委员会,包括普通神经科医生、儿科神经科医生、癫痫专家和药剂师,基于结构化文献综述评估现有证据,该综述包括MEDLINE、《现刊目次》和Cochrane图书馆,检索1987年至2002年9月的相关文章,并进行了截至2003年的部分手工检索。
来自对照试验或剂量对照试验的证据表明,GBP、LTG、TPM和OXC作为单药治疗新诊断的青少年和成人部分性或混合性癫痫发作有效。证据还表明,LTG对新诊断的儿童失神性癫痫有效。缺乏新AEDs治疗新诊断的其他全身性癫痫综合征患者有效性的证据。
这项基于证据的评估结果为新诊断癫痫患者的AEDs处方提供了指导方针,并确定了那些需要更多证据的癫痫发作类型和综合征。