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盐酸美金刚对健康韩国人群 QT/QTc 间期的影响。

Effect of Memantine on QT/QTc Interval in a Healthy Korean Population.

机构信息

Department of Clinical Pharmacology and Toxicology, Anam Hospital, Korea University College of Medicine, Seoul, Korea.

出版信息

Clin Pharmacol Drug Dev. 2021 Oct;10(10):1209-1215. doi: 10.1002/cpdd.931. Epub 2021 Mar 24.

DOI:10.1002/cpdd.931
PMID:33761171
Abstract

Studies on the effects of memantine on QT prolongation have yielded conflicting results. For a long time, memantine was reported to be a safe drug without QT prolongation; however, several case studies have reported memantine-induced QT prolongation in Alzheimer's patients. This study evaluated the relationship between memantine blood levels, and QT interval changes. Over a 2-week period, we orally administered 20 mg of memantine daily to achieve a steady state in 57 healthy Korean subjects. We measured and analyzed the QT interval and blood memantine concentrations simultaneously before and after treatment, as well as 2 weeks after the last dosing. Correlation analysis was done between blood memantine level and QT interval. No serious adverse events occurred during the study period. Repeated dosing of memantine did not show clinically significant QT interval changes after treatment. Regression analysis was performed based on the results; there was no statistical association between memantine blood level and QT prolongation. In conclusion, the results of the present study demonstrated no clinically significant changes in the QT interval with therapeutic blood levels of memantine.

摘要

关于美金刚对 QT 间期延长影响的研究结果相互矛盾。长期以来,美金刚被报道为一种安全的药物,不会引起 QT 间期延长;然而,有几项病例研究报告称,美金刚可引起阿尔茨海默病患者的 QT 间期延长。本研究评估了美金刚血药浓度与 QT 间期变化之间的关系。在 2 周的时间内,我们给 57 名健康韩国受试者每日口服 20mg 美金刚,以达到稳态。我们在治疗前后以及最后一次给药后 2 周同时测量和分析 QT 间期和血液中美金刚的浓度。分析了血美金刚浓度与 QT 间期之间的相关性。研究期间未发生严重不良事件。重复给予美金刚治疗后,QT 间期无明显临床变化。根据结果进行了回归分析;美金刚血药浓度与 QT 延长之间无统计学关联。总之,本研究结果表明,治疗剂量的美金刚不会引起 QT 间期的临床显著变化。

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