Miller Del D, Eudicone James M, Pikalov Andrei, Kim Edward
Department of Psychiatry, University of Iowa, Carver College of Medicine, Iowa City, IA 52242-1000, USA.
J Clin Psychiatry. 2007 Dec;68(12):1901-6. doi: 10.4088/jcp.v68n1210.
To comparatively assess the incidence of tardive dyskinesia in patients with schizophrenia receiving either aripiprazole or haloperidol.
Data from 2 controlled, long-term trials of subjects meeting DSM-IV criteria for schizophrenia treated with aripiprazole (N = 861, 20-30 mg/day) or haloperidol (N = 433, 5-10 mg/day) were analyzed. The primary outcome measure was the rate of new-onset tardive dyskinesia. The analysis was limited to patients without baseline tardive dyskinesia. There were no significant differences between treatment groups in demographic or disease characteristics. The Abnormal Involuntary Movement Scale (AIMS) and Research Diagnostic Criteria for tardive dyskinesia were used to define the comparative incidence rates of long-term treatment-emergent tardive dyskinesia.
A significantly lower percentage of aripiprazole-treated patients developed new-onset tardive dyskinesia compared with haloperidol-treated patients (p < .0001). The annualized rate of treatment-emergent tardive dyskinesia was significantly lower in aripiprazole-treated versus haloperidol-treated patients. In patients without a baseline diagnosis of tardive dyskinesia, aripiprazole significantly improved AIMS scores compared with haloperidol (p <or= .0001).
These findings support the potential for a significantly lower risk of tardive dyskinesia with aripiprazole than with haloperidol among patients requiring maintenance antipsychotic treatment.
比较评估接受阿立哌唑或氟哌啶醇治疗的精神分裂症患者迟发性运动障碍的发生率。
分析了两项对照长期试验的数据,这些试验的受试者符合DSM-IV精神分裂症标准,分别接受阿立哌唑(N = 861,20 - 30毫克/天)或氟哌啶醇(N = 433,5 - 10毫克/天)治疗。主要结局指标是新发迟发性运动障碍的发生率。分析仅限于无基线迟发性运动障碍的患者。治疗组在人口统计学或疾病特征方面无显著差异。使用异常不自主运动量表(AIMS)和迟发性运动障碍研究诊断标准来确定长期治疗出现的迟发性运动障碍的比较发生率。
与接受氟哌啶醇治疗的患者相比,接受阿立哌唑治疗的患者出现新发迟发性运动障碍的百分比显著更低(p <.0001)。阿立哌唑治疗组出现治疗性迟发性运动障碍的年化率显著低于氟哌啶醇治疗组。在无迟发性运动障碍基线诊断的患者中,与氟哌啶醇相比,阿立哌唑显著改善了AIMS评分(p≤.0001)。
这些发现支持了在需要维持抗精神病治疗的患者中,阿立哌唑导致迟发性运动障碍的风险可能显著低于氟哌啶醇。