Reimers Arne, Berg Jon Andsnes, Burns Margrete Larsen, Brodtkorb Eylert, Johannessen Svein I, Johannessen Landmark Cecilie
Department of Clinical Pharmacology, St Olavs University Hospital, Trondheim, Norway.
Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
Drug Des Devel Ther. 2018 Feb 8;12:271-280. doi: 10.2147/DDDT.S154388. eCollection 2018.
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.
实验室有时会对同一种抗癫痫药物（AED）采用不同的参考范围，尤其是对于新的和研究较少的药物。这可能会导致误解、担忧或不适当的剂量调整，进而可能影响治疗效果、药物安全性或治疗依从性。因此，挪威临床药理协会希望更新并统一AED的参考范围，并为挪威制定国家指南。
一个工作组收集了挪威实验室对所有常用AED所使用的参考范围信息。将这些参考范围与国际抗癫痫联盟的最新建议、当前文献、适用的临床研究、挪威以外北欧主要癫痫中心使用的参考范围以及从挪威实验室数据库获得的常规数据进行了比较。
在23种可用的AED中，有4种（拉莫三嗪、丙戊酸盐、依佐卡尼平和奥卡西平）的参考范围在不同实验室之间存在差异。对于4种AED（布瓦西坦、吡仑帕奈、司替戊醇和舒噻美），以前尚未确定参考范围。总共13个参考范围被统一、更新或新建立。其余10种AED未作更改。
挪威现有的23种AED中，有22种已有更新和统一的参考范围。例外的是氨己烯酸（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，必须基于当前文献和临床经验持续进行。
