阿立哌唑治疗分裂情感性障碍的疗效、安全性及耐受性：来自两项随机、双盲、安慰剂对照关键试验的亚组人群汇总分析结果

The efficacy, safety, and tolerability of aripiprazole for the treatment of schizoaffective disorder: results from a pooled analysis of a sub-population of subjects from two randomized, double-blind, placebo-controlled, pivotal trials.

作者信息

Glick Ira D, Mankoski Raymond, Eudicone James M, Marcus Ronald N, Tran Quynh-Van, Assunção-Talbott Sheila

机构信息

Department of Psychiatry and Behavioral Sciences, and Psychopharmacology, Stanford University School of Medicine, Stanford, CA, USA.

出版信息

J Affect Disord. 2009 May;115(1-2):18-26. doi: 10.1016/j.jad.2008.12.017. Epub 2009 Feb 23.

DOI:10.1016/j.jad.2008.12.017

PMID:19230981

Abstract

BACKGROUND

Schizoaffective disorder shares clinical characteristics with schizophrenia and affective disorders, with patients experiencing concurrent manic, mixed, or depressive episodes during psychosis. Because efficacy may be better in schizoaffective disorder than schizophrenia, this post-hoc analysis examines the efficacy, safety, and tolerability of aripiprazole in patients with schizoaffective disorder.

METHOD

Data were obtained from a sub-sample of subjects with schizoaffective disorder (randomized: aripiprazole n=123, placebo n=56) who participated in two 4-week, multicenter, double-blind trials of subjects with schizophrenia or schizoaffective disorder. Aripiprazole was administered at fixed doses of 15 mg/day, 20 mg/day, or 30 mg/day. Efficacy assessments included the Positive and Negative Syndrome Scale (PANSS) Total score, and the Positive, Negative, and General Psychopathology subscale scores. Safety and tolerability evaluations included incidence of treatment-emergent adverse events and extrapyramidal symptom assessments (SAS, BARS, and AIMS), and metabolic profile changes including weight and BMI.

RESULTS

A significantly greater improvement from baseline to endpoint was observed with aripiprazole compared with placebo on the PANSS Total (-15.9 vs. -3.4; p=0.038) and PANSS Positive subscale (-4.6 vs. -1.0; p=0.027). Differences between treatments were not significant for the PANSS Negative subscale score (-3.7 vs. -1.2; p=0.15) or PANSS General Psychopathology subscale score (-8.3 vs. -3.1; p=0.06). There were no statistically significant differences at endpoint between groups in the mean change from baseline to endpoint in weight, glucose, or total cholesterol, or on SAS, BARS, or AIMS scores. There was a statistically significant decrease in prolactin in subjects treated with aripiprazole compared with placebo (-5.6 vs. -1.3, p<0.001).

CONCLUSION

Aripiprazole was efficacious and well tolerated in patients with schizoaffective disorder.

摘要

背景

分裂情感性障碍兼具精神分裂症和情感障碍的临床特征，患者在精神病发作期间会同时出现躁狂、混合或抑郁发作。由于分裂情感性障碍患者使用阿立哌唑的疗效可能优于精神分裂症患者，因此本事后分析旨在研究阿立哌唑治疗分裂情感性障碍患者的疗效、安全性和耐受性。

方法

数据来自参与两项针对精神分裂症或分裂情感性障碍患者的为期4周的多中心双盲试验的分裂情感性障碍受试者子样本（随机分组：阿立哌唑组n = 123，安慰剂组n = 56）。阿立哌唑的固定剂量为每日15毫克、20毫克或30毫克。疗效评估包括阳性和阴性症状量表（PANSS）总分以及阳性、阴性和一般精神病理学分量表得分。安全性和耐受性评估包括治疗中出现的不良事件发生率和锥体外系症状评估（SAS、BARS和AIMS），以及代谢指标变化，包括体重和BMI。

结果

与安慰剂相比，阿立哌唑治疗组从基线到终点的PANSS总分（-15.9对-3.4；p = 0.038）和PANSS阳性分量表得分（-4.6对-1.0；p = 0.027）有显著更大改善。治疗组之间在PANSS阴性分量表得分（-3.7对-1.2；p = 0.15）或PANSS一般精神病理学分量表得分（-8.3对-3.1；p = 0.06）方面差异不显著。在体重、血糖或总胆固醇从基线到终点的平均变化方面，以及在SAS、BARS或AIMS评分方面，各治疗组在终点时无统计学显著差异。与安慰剂相比，接受阿立哌唑治疗的受试者催乳素水平有统计学显著下降（-5.6对-1.3，p < 0.001）。