目的:实验室有时对相同的抗癫痫药(AED)使用不同的参考范围,特别是对于新的和研究不足的药物。这可能会导致误解,担忧或不适当的剂量变化,这反过来可能会影响治疗效果,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和统一AED的参考范围,并为挪威制定国家指南.
方法:一个工作组收集了挪威实验室对所有常用AED使用的参考范围的信息。将这些参考范围与国际抗癫痫联盟最近的建议进行了比较,当前文学,适用的临床研究,挪威以外的北欧领先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。
结果:23个可用AED中的4个实验室的参考范围不同(拉莫三嗪,丙戊酸盐,艾司利卡西平和奥卡西平)。对于四个AED(brivaracetam,Perampanel,stiripentolandsulthiame),以前没有建立参考范围.总的来说,13个参考范围要么统一,更新或新建立。其余10个AED没有变化。
结论:挪威23个AED中的22个现在有更新和统一的参考范围。vigabatrin是个例外(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,并且必须是基于当前文献和临床经验的连续过程。
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.