Department of Neurosciences and Mental Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Department of Neurosciences and Mental Health, Psychopharmacology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Pharmacopsychiatry. 2020 Sep;53(5):209-219. doi: 10.1055/a-1113-7862. Epub 2020 Mar 10.
The objective of this study was the evaluation of utility of plasma level monitoring in the clinical stabilizing efficacy and tolerability of paliperidone palmitate (PP) vs. aripiprazole monohydrate (AM) in bipolar disorder I (BD I) with manic predominance.
Fifty-six outpatients of both sexes, age ranging from 18 to 65 years, affected by BD I with manic predominance, orally treated and stabilized after acute episode for at least 2 weeks with paliperidone or aripiprazole (n=31, paliperidone; n=25, aripiprazole) underwent a prospective observational study of switching to the corresponding long-acting injection (LAI) on the basis of clinical evaluation. The efficacy and tolerability of the 2 treatments were assessed by BPRS, PANSS, HAMD21, and MRS rating scales and a check list every month for 12 months. Drug plasma levels determinations (PLs) were performed at the same times.
A good clinical stability and tolerability of both drugs were reported. Lower mean PLs of PP showed a positive effect on depressive symptoms. AM PLs variability was associated with greater instability of manic symptoms whereas intermediate PLs seem to have more influence on depressive symptomatology.
PLs drug monitoring has been proven to be useful, and further investigations to identify optimal therapeutic ranges for LAI formulations are needed.
本研究的目的是评估在双相情感障碍 I 型（BD I）以躁狂为主导的患者中，使用棕榈酸帕利哌酮（PP）与阿立哌唑一水合物（AM）进行血浆水平监测对临床稳定疗效和耐受性的效用。
56 名年龄在 18 至 65 岁之间的男女门诊患者，患有以躁狂为主导的 BD I，在急性发作后至少 2 周内接受口服治疗并稳定，使用帕利哌酮或阿立哌唑（n=31，帕利哌酮；n=25，阿立哌唑），根据临床评估进行前瞻性观察性研究，转换为相应的长效注射剂（LAI）。使用 BPRS、PANSS、HAMD21 和 MRS 评分量表以及每月一次的检查表在 12 个月内评估两种治疗的疗效和耐受性。在相同时间进行药物血浆水平（PL）测定。
报告了两种药物均具有良好的临床稳定性和耐受性。PP 的平均 PL 较低，对抑郁症状有积极影响。AM PL 的变异性与躁狂症状的更大不稳定性相关，而中间 PL 似乎对抑郁症状有更大的影响。
药物 PL 监测已被证明是有用的，需要进一步研究以确定 LAI 制剂的最佳治疗范围。
