依帕司他治疗糖尿病周围神经病变有效性及安全性的 Meta 分析

Plasma concentration and clinical effects of perampanel-The Kork experience.

机构信息

Epilepsiezentrum Kork, Landstrasse 1, 77694, Kehl-Kork, Germany.

出版信息

Seizure. 2019 Apr;67:18-22. doi: 10.1016/j.seizure.2019.02.022. Epub 2019 Feb 28.

DOI:10.1016/j.seizure.2019.02.022

PMID:30852267

Abstract

PURPOSE

To investigate the correlation between steady-state plasma concentrations of perampanel (PER) with efficacy and tolerability in adult patients with difficult-to-treat epilepsy.

METHODS

PER plasma concentrations were assessed at steady-state conditions in 92 adult patients (57% female, 43% male, mean age 39,5 years, age range 20-73 years). All patients had been treated with PER at a stable dose for at least 3 weeks. Clinical efficacy was assessed on the day of measuring the plasma concentrations by a retrospective analysis of the seizure frequency and adverse effects.

RESULTS

The mean overall plasma concentration was 323,5 ng/ml (range 19 ng/ml - 2436 ng/ml). The corresponding mean dose was 7,5 mg (range 2 mg - 12 mg). PER dose and plasma concentration showed a close linear correlation. Plasma levels and doses varied widely concerning both efficacy and tolerability of PER. The differences between plasma levels of responders and non-responders were not statistically significant. Therefore a clinically useful general reference range could not be defined.

CONCLUSION

Our data do not indicate a reliable therapeutic range for PER plasma concentrations. Individual reference ranges varied widely. Therapeutic drug monitoring (TDM) may still be helpful in certain clinical situations.

摘要

目的

研究成人难治性癫痫患者稳态血浆中氨己烯酸（PER）浓度与疗效和耐受性的相关性。

方法

在 92 名成年患者（57%为女性，43%为男性，平均年龄 39.5 岁，年龄范围 20-73 岁）中评估了稳态条件下 PER 血浆浓度。所有患者均以稳定剂量 PER 治疗至少 3 周。通过对癫痫发作频率和不良反应的回顾性分析，在测量血浆浓度的当天评估临床疗效。

结果

平均总血浆浓度为 323.5ng/ml（范围 19ng/ml-2436ng/ml）。相应的平均剂量为 7.5mg（范围 2mg-12mg）。PER 剂量和血浆浓度呈密切的线性相关。PER 的疗效和耐受性方面，血浆水平和剂量差异很大。应答者和无应答者之间的血浆水平差异无统计学意义。因此，无法定义一个临床有用的一般参考范围。