Schreiner Andreas, Bergmans Paul, Cherubin Pierre, Hargarter Ludger
Medical and Scientific Affairs, Janssen Cilag EMEA, Johnson & Johnson Platz 1, Neuss, 41470, Germany.
Biometrics, Janssen Cilag Benelux, Tilburg, The Netherlands.
Ther Adv Psychopharmacol. 2017 Feb;7(2):59-65. doi: 10.1177/2045125316673012. Epub 2016 Oct 14.
The negative symptoms of schizophrenia are generally harder to recognize, more difficult to treat than positive symptoms, and have a significant impact on patient functioning and overall outcomes. Treatment with aripiprazole may be associated with benefits on negative symptoms and functioning given its partial agonism to the dopamine D receptor. The aim of this subanalysis was to explore the impact of flexibly dosed, long-acting paliperidone palmitate once monthly (PP1M) on negative and depressive symptoms, disorganized thoughts, anxiety, extrapyramidal symptoms, and patient functioning in nonacute adult patients with schizophrenia previously unsuccessfully treated with oral aripiprazole monotherapy.
subanalysis of 46 nonacute but symptomatic patients enrolled in a prospective, interventional, single-arm, multicenter, open-label 6-month study.
At endpoint, improvements of ⩾ 20% and ⩾ 50% in the Positive and Negative Syndrome Scale (PANSS) total score were observed in 52.2% and 21.7% of patients, respectively. Significant and clinically relevant improvements were observed at endpoint in mean (standard deviation [SD]) PANSS negative subscale score (-3.0 (5.0); < 0.0001) and in the PANSS Marder factor scores for negative symptoms (-2.9 (5.4); = 0.0006), disorganized thoughts (-2.8 (4.3); < 0.0001) and anxiety/depression (-1.8 (3.9); = 0.0031). Patient functioning assessed by mean (SD) Personal and Social Performance scale score (3.9 (13.2); = 0.0409), Mini International Classification of Functioning rating for Activity and Participation Disorders in Psychological Illnesses total scores (-2.9 (7.1); = 0.0079), and Extrapyramidal Symptom Rating Scale scores (-0.6 (3.4); = 0.0456) improved significantly at endpoint. PP1M was well tolerated with no new safety signals.
Six-month treatment with flexibly dosed PP1M was associated with significant and clinically relevant improvements in negative and depressive symptoms, disorganized thoughts, functioning, and extrapyramidal symptoms in nonacute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral aripiprazole.
精神分裂症的阴性症状通常比阳性症状更难识别、更难治疗,并且对患者的功能和总体预后有重大影响。阿立哌唑治疗可能因其对多巴胺D受体的部分激动作用而对阴性症状和功能有益。本亚组分析的目的是探讨灵活给药的长效棕榈酸帕利哌酮每月一次(PP1M)对先前接受口服阿立哌唑单药治疗未成功的非急性成年精神分裂症患者的阴性和抑郁症状、思维紊乱、焦虑、锥体外系症状及患者功能的影响。
对46例非急性但有症状的患者进行亚组分析,这些患者参加了一项前瞻性、干预性、单臂、多中心、开放标签的6个月研究。
在研究终点,分别有52.2%和21.7%的患者阳性和阴性症状量表(PANSS)总分改善≥20%和≥50%。在研究终点,观察到PANSS阴性分量表平均(标准差[SD])得分(-3.0(5.0);P<0.0001)、PANSS Marder阴性症状因子得分(-2.9(5.4);P = 0.0006)、思维紊乱因子得分(-2.8(4.3);P<0.0001)和焦虑/抑郁因子得分(-1.8(3.9);P = 0.0031)有显著且具有临床意义的改善。通过平均(SD)个人和社会表现量表得分(3.9(13.2);P = 0.0409)、心理疾病活动和参与障碍的国际功能、残疾和健康分类简表总分(-2.9(7.1);P = 0.0079)以及锥体外系症状评定量表得分(-0.6(3.4);P = 0.0456)评估的患者功能在研究终点有显著改善。PP1M耐受性良好,未出现新的安全信号。
对于先前接受口服阿立哌唑治疗未成功的非急性但有症状的精神分裂症患者,灵活给药的PP1M进行6个月治疗可使阴性和抑郁症状、思维紊乱、功能及锥体外系症状有显著且具有临床意义的改善。