Cooper S J, Tweed J, Raniwalla J, Butler A, Welch C
Department of Mental Health, The Queen's University of Belfast, Northern Ireland.
Acta Psychiatr Scand. 2000 Mar;101(3):218-25.
The aim of this study was to evaluate the efficacy of zotepine in the treatment of acute episodes of schizophrenia.
Patients with acute exacerbation of schizophrenia (DSM-III-R criteria; n = 158) were allocated on a random, double-blind basis to receive zotepine (150 or 300 mg/day), chlorpromazine (300 or 600 mg/day) or placebo for 8 weeks. Symptoms were assessed on the BPRS, SANS and CGI scales at baseline and weeks 1, 2, 4, 6 and 8 and patients were assessed at these times for adverse effects. Analysis was by analysis of variance on the intent-to-treat population, with last observation carried forward.
Mean BPRS scores improved statistically significantly more with zotepine than chlorpromazine (point estimate of difference -12.4, 95% CI -18.3 to -6.5) or placebo (point estimate of difference -12.7, 95% CI -18.6 to -6.8). Zotepine produced significantly fewer extrapyramidal symptoms (EPS) than chlorpromazine.
Zotepine is an effective antipsychotic with low propensity for EPS.
本研究旨在评估氯氮平治疗精神分裂症急性发作的疗效。
将符合精神分裂症急性加重（DSM-III-R标准；n = 158）的患者随机、双盲分配，接受氯氮平（150或300毫克/天）、氯丙嗪（300或600毫克/天）或安慰剂治疗8周。在基线以及第1、2、4、6和8周时，使用简明精神病评定量表（BPRS）、阴性症状评定量表（SANS）和临床总体印象量表（CGI）对症状进行评估，并在这些时间点对患者的不良反应进行评估。采用意向性分析人群的方差分析，采用末次观察结转法。
氯氮平治疗后，简明精神病评定量表的平均得分改善在统计学上显著优于氯丙嗪（差异点估计值为-12.4，95%可信区间为-18.3至-6.5）或安慰剂（差异点估计值为-12.7，95%可信区间为-18.6至-6.8）。氯氮平产生的锥体外系症状（EPS）明显少于氯丙嗪。
氯氮平是一种有效的抗精神病药物，发生锥体外系症状的倾向较低。
