Tomita Tetsu, Yasui-Furukori Norio, Nakagami Taku, Tsuchimine Shoko, Ishioka Masamichi, Kaneda Ayako, Nakamura Kazuhiko, Kaneko Sunao
Department of Neuropsychiatry, Graduate School of Medicine, Hirosaki University, Japan.
Ther Drug Monit. 2014 Aug;36(4):480-5. doi: 10.1097/FTD.0000000000000036.
We investigated the relationship between plasma concentrations of paroxetine and the therapeutic effect of the drug, and we evaluated the therapeutic reference range for plasma concentration of paroxetine in patients with major depressive disorders (MDD).
In this study, 120 patients with MDD were treated with 10-40 mg/d of paroxetine for 6 weeks, and 89 patients completed the protocol. The Montgomery-Asberg Depression Rating Scale (MADRS) was used to evaluate the patients at 0, 1, 2, 4, and 6 weeks. At the 6-week treatment time point, the patients were divided into 7 groups according to their paroxetine plasma concentrations in increments of 20 ng/mL. We used an analysis of variance and a χ test to define the therapeutic reference range for plasma paroxetine concentrations.
We used 50% as the cutoff values for the percentage of MADRS improvement to determine the responder rates, and we defined remitters as patients with MADRS scores <10 at the 6-week treatment time point. We analyzed the responder and remitter rates of the patients according to their plasma paroxetine concentrations: 20 ng/mL, 40 ng/mL, and 60 ng/mL using the χ test. According to the results of the χ test in the responder rates, the 20-60 ng/mL plasma paroxetine group showed the highest effect size.
The results of this study suggested that a range of 20-60 ng/mL is the therapeutic reference range for concentrations of paroxetine in plasma in patients with MDD.
我们研究了帕罗西汀血浆浓度与药物治疗效果之间的关系，并评估了重度抑郁症（MDD）患者血浆中帕罗西汀浓度的治疗参考范围。
在本研究中，120例MDD患者接受10 - 40mg/d的帕罗西汀治疗6周，89例患者完成了方案。使用蒙哥马利-阿斯伯格抑郁评定量表（MADRS）在0、1、2、4和6周时对患者进行评估。在6周治疗时间点，根据患者帕罗西汀血浆浓度以20ng/mL的增量分为7组。我们使用方差分析和χ检验来确定血浆帕罗西汀浓度的治疗参考范围。
我们将MADRS改善百分比的50%作为截止值来确定缓解率，并将在6周治疗时间点MADRS评分<10的患者定义为缓解者。我们使用χ检验根据患者血浆帕罗西汀浓度：20ng/mL、40ng/mL和60ng/mL分析了缓解者和缓解率。根据χ检验在缓解率方面的结果，20 - 60ng/mL血浆帕罗西汀组显示出最高的效应量。
本研究结果表明，20 - 60ng/mL的范围是MDD患者血浆中帕罗西汀浓度的治疗参考范围。
