Reference ranges for antiepileptic drugs revisited: a practical approach to establish national guidelines.
Reference ranges for antiepileptic drugs revisited: a practical approach to establish national guidelines.
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DOI：
10.2147/dddt.s154388
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发表时间：
2018
期刊：
影响因子：
--
通讯作者：
Johannessen Landmark C
中科院分区：
文献类型：
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作者：
Reimers A;Berg JA;Burns ML;Brodtkorb E;Johannessen SI;Johannessen Landmark C
实验室有时对同一种抗癫痫药物（AED）使用不同的参考范围，特别是对新药和研究不足的药物。这可能会导致误解、担忧或不适当的剂量变化，从而影响治疗效果、药物安全性或治疗依从性。因此，挪威临床药理学协会希望更新和协调aed的参考范围，并为挪威建立国家指南。一个工作组收集了挪威实验室对所有常用除颤器使用的参考范围的信息。这些参考范围与国际抗癫痫联盟最近的建议、当前文献、适用的临床研究、挪威以外主要北欧癫痫中心使用的参考范围以及来自挪威实验室数据库的常规数据进行了比较。在23种可用的aed药物中，有4种（拉莫三嗪、丙戊酸、埃斯卡巴西平和奥卡西平）的参考值范围因实验室而异。对于四种AEDs（布瓦西坦，perampanel，斯特里哌醇和磺胺），参考范围以前未建立。共协调、更新或新建立了13个参考范围。其余10个aed没有变化。挪威现有的23种aed中的22种现已更新和统一的参考范围。例外是vigabatrin（参考范围不适用）。参考范围的修订是aed药物警戒的重要组成部分，必须是一个基于现有文献和临床经验的持续过程。
Laboratories sometimes use different reference ranges for the same antiepileptic drug (AED), particularly for new and poorly investigated drugs. This may contribute to misunderstandings, concerns or inappropriate dose changes, which in turn may affect therapeutic effect, drug safety or treatment adherence. Therefore, the Norwegian Association of Clinical Pharmacology wished to update and harmonize the reference ranges for AEDs and establish national guidelines for Norway. A working group collected information on the reference ranges used by Norwegian laboratories for all commonly used AEDs. These reference ranges were compared to recent recommendations by the International League Against Epilepsy, current literature, applicable clinical studies, reference ranges used by leading Northern European epilepsy centers outside of Norway, and routine data derived from Norwegian laboratory databases. Reference ranges varied between laboratories for four of 23 available AEDs (lamotrigine, valproate, eslicarbazepine and oxcarbazepine). For four AEDs (brivaracetam, perampanel, stiripentol and sulthiame), reference ranges had not previously been established. In total, 13 reference ranges were either harmonized, updated or newly established. No changes were applied to the remaining 10 AEDs. Updated and harmonized reference ranges are now available for 22 of the 23 AEDs available in Norway. The exception is vigabatrin (reference range not applicable). Revision of reference ranges is an important part of pharmacovigilance of AEDs and must be a continuous process based on current literature and clinical experience.