阿立哌唑用于预防慢性精神分裂症病情稳定患者的复发：一项为期26周的安慰剂对照研究。

Aripiprazole for the prevention of relapse in stabilized patients with chronic schizophrenia: a placebo-controlled 26-week study.

作者信息

Pigott Teresa A, Carson William H, Saha Anutosh R, Torbeyns Anne F, Stock Elyse G, Ingenito Gary G

机构信息

Department of Psychiatry, University of Florida, UF Brain Institute L4-100, P.O. Box 100256, Gainesville, FL 32610-0256, USA.

出版信息

J Clin Psychiatry. 2003 Sep;64(9):1048-56. doi: 10.4088/jcp.v64n0910.

DOI:10.4088/jcp.v64n0910

PMID:14628980

Abstract

BACKGROUND

Aripiprazole is a novel antipsychotic for the management of schizophrenia. This study investigated the efficacy, safety, and tolerability of aripiprazole in preventing relapse in adult chronic schizophrenia patients experiencing ongoing stable symptomatology.

METHOD

In this 26-week, randomized, double-blind, placebo-controlled, parallel-group, multi-center study, 310 patients with DSM-IV schizophrenia (mean Positive and Negative Syndrome Scale [PANSS] total score = 82) were randomly assigned to receive a once-daily fixed dose of aripiprazole, 15 mg, or placebo. The primary outcome measure was time to relapse following randomization. Secondary objectives were to assess the efficacy, safety, and tolerability of aripiprazole, 15 mg, compared with placebo, in the study population. The study was conducted between Dec. 21, 2000, and Aug. 20, 2001.

RESULTS

The time to relapse following randomization was significantly (p < .001) longer for aripiprazole compared with placebo. More patients relapsed with placebo (N = 85; 57%) than aripiprazole (N = 50; 34%); the relative risk of relapse for the aripiprazole group was 0.59 (p < .001). Aripiprazole was significantly superior to placebo from baseline to endpoint in PANSS total, PANSS positive, PANSS-derived Brief Psychiatric Rating Scale, and Clinical Global Impressions-Severity of Illness scale (CGI-S) scores and demonstrated significantly better mean Clinical Global Impressions-Global Improvement scale scores (p < or = .01 for all comparisons except CGI-S: .01 < p < or = .05). Aripiprazole was well tolerated, with no evidence of marked sedation and no evidence of hyperprolactinemia or prolonged heart rate-corrected QT interval (QTc). Extrapyramidal symptoms were comparable in the aripiprazole and placebo groups. Modest mean weight loss at endpoint was evident in both groups.

CONCLUSION

Aripiprazole, 15 mg once daily, is an effective, well-tolerated treatment for prevention of relapse in patients with chronic, stable schizophrenia.

摘要

背景

阿立哌唑是一种用于治疗精神分裂症的新型抗精神病药物。本研究调查了阿立哌唑在预防有持续稳定症状的成年慢性精神分裂症患者复发方面的疗效、安全性和耐受性。

方法

在这项为期26周的随机、双盲、安慰剂对照、平行组、多中心研究中，310例符合《精神疾病诊断与统计手册》第四版（DSM-IV）精神分裂症标准的患者（阳性和阴性症状量表[PANSS]总分平均为82分）被随机分配，接受每日一次的固定剂量15毫克阿立哌唑或安慰剂治疗。主要结局指标是随机分组后至复发的时间。次要目标是评估与安慰剂相比，15毫克阿立哌唑在研究人群中的疗效、安全性和耐受性。该研究于2000年12月21日至2001年8月20日进行。

结果

与安慰剂相比，阿立哌唑随机分组后至复发的时间显著更长（p < .001）。安慰剂组复发的患者（N = 85；57%）多于阿立哌唑组（N = 50；34%）；阿立哌唑组复发的相对风险为0.59（p < .001）。从基线到终点，阿立哌唑在PANSS总分、PANSS阳性分、PANSS衍生的简明精神病评定量表以及临床总体印象-疾病严重程度量表（CGI-S）评分方面均显著优于安慰剂，并且在临床总体印象-总体改善量表评分方面也显著更好（除CGI-S外，所有比较的p < 或 = .01；CGI-S：.01 < p < 或 = .05）。阿立哌唑耐受性良好，没有明显镇静的证据，也没有高催乳素血症或心率校正QT间期（QTc）延长的证据。阿立哌唑组和安慰剂组的锥体外系症状相当。两组在终点时均出现适度的平均体重减轻。