TY - T1的狭窄的抗癫痫药物治疗指数分类使用一个全面的文献检索(P2.053) JF -神经学乔-神经学六世- 86 - 16补充SP - P2.053盟杰夫Guptill Chiara Melloni AU -雷切尔·格林伯格盟盟华力吴盟-丹尼尔·冈萨雷斯盟首页劳伦斯Ku AU -凯文希尔盟Christoph Hornik AU -南郑AU -江Wenlei盟-迈克尔Cohen-Wolkowiez Y1 - 2016/04/05 UR - //www.ez-admanager.com/content/86/16_Supplement/P2.053.abstract N2 -目的:确定从医学文献获取的数据可以用来估计5抗癫痫药物的治疗指数(aed):卡马西平、拉莫三嗪、苯巴比妥、苯妥英、丙戊酸钠。背景:狭窄的治疗指数(NTI)药物表现出非常接近边缘之间的治疗和有毒的血药浓度,和小的改变药物暴露可能导致严重的治疗失败和/或不良事件。有一个小的治疗窗口是NTI分类的主要标准之一。NTI药物可能需要更严格的监管。在美国超过150 aed已获批准;有多少个可能成为NTI药物是未知的。方法:我们进行了文献检索使用PubMed和Embase收集出版安全、功效,和治疗监测数据5 aed,和所有相关信息提取到药物,一些具体的数据库。对于每个AED,我们总结:1)类型,严重程度,toxicity-related不良事件的发生率和toxicity-associated药物剂量范围/浓度;2)有效的和有毒的浓度和剂量(治疗范围)。我们定义治疗指数的比率最低有毒浓度最低有效浓度。 We considered a therapeutic index ≤2 as a criterion to classify the therapeutic index as narrow. Results: We reviewed a total of 810 full-text articles and extracted data from 163 articles. The available literature suggests that the therapeutic index of phenytoin is <2. The therapeutic indices of phenobarbital and valproate exceed 2. There was insufficient data to precisely quantify the therapeutic indices of carbamazepine and lamotrigine. Conclusions: Our approach offers a low-cost method of therapeutic index estimation for some drugs using existing data. Our results can serve as preliminary data for future trials and as guidance for FDA decision-making regarding NTI classification. Study supported by: NIH-3U01FD004858-01Disclosure: Dr. Guptill has received personal compensation for activities with Jacobus Pharmaceuticals, Marinus, Momenta, Serimmune, and UCB Pharma, Inc for consulting services and from Grifols for educational activities. Dr. Guptill has received research support fro Dr. Greenberg has nothing to disclose. Dr. Melloni has received research support from Amgen, Inc., AstraZeneca, GlaxoSmithKline, and Hoffmann-La Roche. Dr. Wu has nothing to disclose. Dr. Gonzalez has nothing to disclose. Dr. Ku has nothing to disclose. Dr. Hill has nothing to disclose. Dr. Hornik has nothing to disclose. Dr. Zheng has nothing to disclose. Dr. Jiang has nothing to disclose. Dr. Cohen-Wolkowiez has received personal compensation for activities with Cempra Pharmaceuticals Inc., Gilead Sciences, Inc., Jacobus Pharmaceuticals, and Tetraphase Pharmaceuticals.Sunday, April 17 2016, 8:30 am-5:30 pm ER -