常用抗癫痫药初始单药长疗程治疗效果的新指标评价研究

New Measurement Indicator for the Effectiveness of Initial Monotherapy for Chronic Epilepsy with Long-term Commonly Used Antiepileptic Drugs

目的：了解新评价指标应用于常用抗癫痫药物（AEDs）初始单药长疗程治疗效果的研究结果。方法：检索国际上常用的生物医学大型文献数据库,收集我国常用AEDs的初始单药长疗程治疗效果评价的国内外研究文献,提取纳入文献的有效信息,采用文献综述的描述性分析方法进行评价分析。结果：共纳入6篇文献,研究文献存在明显的异质性。评价显示：卡马西平（CBZ）1年保留率65%~77.8%,2年保留率57%~65.9%,3年保留率53%~59.5%;第1年无发作率27.6%~52.4%,第2年55.2%~60%,第3年49.6%~69%;老年患者保留率和年无发作率均较低;远期不良反应和疗效不佳是停药的主要原因。丙戊酸钠（VPA）1~3年保留率70%左右、年无发作率50%左右,老年患者年无发作率明显偏低,停药原因主要是疗效不佳和不良反应。拉莫三嗪（LTG）保留率较高：1年保留率75%以上,2年保留率65%~75%,3年保留率59%,年无发作率约50%,保留率高与耐受性较好有关。托吡酯（TPM）1年保留率52%~75%,2年保留率42%~68%,3年保留率45%~54%,比其他AEDs均低;第1年无发作率33%~53%,第2年45%~55%,第3年43%~67%;停药原因主要是远期不良反应,如认知功能障碍。奥卡西平（OXC）1年保留率63%,2年保留率56%~59%,3年保留率56%;第1年无发作率35%,第2年57%,第3年68%。因不良反应停药的不多。左乙拉西坦（LEV）1年保留率66%~73%,2年保留率46%~54%,第1年无发作率43%。常见不良反应是停药主要原因。结论：保留率和年无发作率是近年来用于评价癫痫患者长疗程治疗效果的新指标,能较好地反映癫痫药物临床治疗的真实效果。

Objective：To review the evaluation of new measurement indicator for the effectiveness of initial monotherapy in patients with chronic epilepsy in long-term commonly used antiepileptic drugs（AEDs）.Methods：Research articles regarding the evaluation of the long-term effectiveness of an initial monotherapy with AEDs were collected by searching for the international biomedical literature databases.Their effective messages matching the criterion were screened to be systematically reviewed.Results：Only 6 studies matched the criterion.The way of describing the literature had their heterogeneity.The retention rates for carbamazepine（CBZ） were 65.0%-77.8%for one year,57.0%-65.9%for two years and 53.0%-59.5%for three years.Its seizure freedom rates were 27.6%-52.4%for the first year,55.2%-60.0%for the second year and 49.6%-69%for the third year.The retention rate and seizure freedom rate in elderly patients were lower.The long-term adverse events（AE） and lack of efficacy（LE） were the main reasons for discontinuation.The retention rate and seizure freedom rate for valproate（VPA） were approximately 70%and 50%respectively in the first year.But seizure reedom rate was obviously low in elderly patients.The reasons for discontinuation were the same as CBZ.Lamotrigine（LTG） showed the highest retention rate;more than 75%for one year,65%-75%for two years and 59%for three years.About 50%patients were free from seizures for the first year.Better tolerance contributed to the higher retention rate of LTG.Compared to the others,topiramate（TPM） easily led to its treatment failure,52%-75%,42%-68%and 45%54%patients kept the treatment with TPM for one,two and three years.33%-53%,45%-55%and 43%-67%patients kept the seizure free for the first,second and third year.The long-term AE,especially the cognition impairments mainly led to the treatment failure of TPM.The retention rate and seizure freedom rate of oxcarbazepine（OXC） treatment were 63%, 56%-59%,56%and 35%,57%,68%respectively for the first,second and third year.Few patients experienced a discontinuation on OXC because of AE.For levetiracetam（LEV）,66%-73%,46%-54%patients kept on their LEV treatment for the one and two years,accounting for lower proportion than LTG.The seizure freedom rate of LEV was 43%for the first year.The main cause of discontinuation of LEV usually was AE.Conclusion：The retention rate and seizure freedom rate,for one-year,were the new measurement indicator.The long-term effectiveness of initial monotherapy with AEDs could reflect the actual effectiveness in everyday clinical practice.