抗癫癎药物应用指南Ⅰ:新型抗癫癎药物的药力和安全性:新发癫癎的治疗 美国神经病学学会治疗学和技术评定分委会和质量标准分委会及美国癫癎协会报告

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目的对有关7种用以治疗儿童和成人新诊断部分性和全身性癫癎的新型抗癫癎药物(AEDs):加巴喷丁(gabapentin,GBP)、拉莫三嗪(lamotrigine,LTG)、托吡酯(topiramate,TPM)、噻加宾(tiagabine,TGB)、奥卡西平(oxcarbazepine,OXC)、左乙拉西坦(levetiracetam,LEV)和唑尼沙胺(zonisamide,ZNS)的药力(efficacy)、耐受性和安全性按序进行评估(这些药物已受到美国食品与药品管理局FDA的批准)。方法由23位成人神经病学家、儿科神经病学家、癫癎病学家及药理学家组成的,依据从1987年到2002年9月Medline,Current Contents和Cochrane上发表的相关文献和2003年以前的指南提供的证据进行专家组循证医学评估。结果有证据通过对照试验或剂量控制试验显示:加巴喷丁、拉莫三嗪、托吡酯和奥卡西平单药治疗对新诊断的青少年和成人部分性或混合性癫癎是有效的。亦有证据显示,拉莫三嗪对于新诊断的儿童失神发作有效。但尚缺乏证据证明新型抗癫癎药物对新诊断的其他类型的全身性癫癎综合征是否有效。结论循证医学评估结果提供了新诊断癫癎患者的抗癫癎药物应用指南,但尚需更多的证据用以鉴定其在癫癎的类型或综合征中的疗效。 OBJECTIVES: To investigate novel anti-epileptic drugs (AEDs) for seven new types of partial and generalized epilepsy for the treatment of children and adults: gabapentin (GBP), lamotrigine (LTG), topiramate , TPM), tiagabine (TGB), oxcarbazepine (OXC), levetiracetam (LEV) and zonisamide (ZNS) Sexual and safety evaluations were performed in sequence (these drugs have been approved by the FDA of the United States Food and Drug Administration). The method consisted of 23 adult neurologists, pediatric neurologists, epilepsy therapists and pharmacologists based on the published literature from Medline, Current Contents and Cochrane from 1987 to September 2002 and before 2003 The evidence provided by the guidelines is evaluated by an expert group on evidence-based medicine. Results There is evidence that controlled trials or dose-control studies have shown that gabapentin, lamotrigine, topiramate and oxcarbazepine monotherapy are effective in newly diagnosed adolescents and adults with partial or mixed epilepsy. There is also evidence that lamotrigine is effective in the absence of new diagnoses in children. However, there is a lack of evidence to prove whether the new antiepileptic drugs are effective in newly diagnosed other types of generalized epilepsy syndromes. Conclusion The evidence-based medical evaluation provides guidelines for antiepileptic drug use in newly diagnosed epilepsy patients, but more evidence is needed to identify its efficacy in the type or syndrome of epilepsy.
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