Ziprasidone 40 and 120 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: a 4-week placebo controlled trial
Ziprasidone 40 and 120 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: a 4-week placebo controlled trial
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DOI：
10.1007/s002130050755
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发表时间：
1998-11-01
影响因子：
3.4
通讯作者：
Morrissey, MR
中科院分区：
文献类型：
--
作者：
Keck, P;Buffenstein, A;Morrissey, MR
采用双盲、安慰剂对照、多中心研究方法，评价齐拉西酮治疗139例精神分裂症或情感性精神障碍急性发作患者的疗效和安全性。患者随机接受齐拉西酮40 mg/天、120 mg/天或安慰剂治疗28天。齐拉西酮120 mg/d在改善BPRS总分、CGI-S、BPRS抑郁簇和BPRS运动障碍簇评分方面比安慰剂显著更有效（均P < 0.05），类似地，在BPRS上分类为应答者的患者百分比（大于或等于30%的减少）和CGI改善与安慰剂相比，齐拉西酮120 mg/天组（评分小于或等于2）显著更高（P < 0.05），所有三个治疗组中发生不良事件的患者数量相似，由于不良事件而停药的情况很少见（91例齐拉西酮治疗患者中有5例）。最常报告的不良事件是消化不良、便秘、恶心和腹痛，齐拉西酮组比安慰剂组更常见。锥体外系副作用（包括静坐不能）和体位性低血压的发生率明显较低，无实验室异常或明显体重增加的模式。齐拉西酮治疗患者与安慰剂治疗患者在C-Angus评定量表、巴恩斯静坐不能量表和AIMS评估方面无临床差异。这些结果表明，齐拉西酮120 mg/天可有效治疗精神分裂症和情感障碍的阳性、阴性和情感症状，副作用负担非常低。
A double-blind, placebo-controlled, multicenter study, was performed to evaluate the efficacy and safety of ziprasidone in 139 patients with an acute exacerbation of schizophrenia or schizoaffective disorder. Patients were randomized to receive ziprasidone 40 mg/day, 120 mg/day or placebo for 28 days. Ziprasidone 120 mg/day was significantly more effective than placebo in improving the BPRS total, CGI-S, BPRS depression cluster and BPRS anergia cluster scores (all P < 0.05), Similarly, the percentages of patients classified as responders on the BPRS (greater than or equal to 30% reduction) and the CGI improvement (score less than or equal to 2) were significantly greater with ziprasidone 120 mg/day compared with placebo (P < 0.05), The number of patients who experienced an adverse event was similar in all three treatment groups, and discontinuation due to adverse events was rare (five of 91 ziprasidone-treated patients). The most frequently reported adverse events, that were more common in either ziprasidone group than in the placebo group, were dyspepsia, constipation, nausea and abdominal pain. There was a notably low incidence extrapyramidal side-effects (including akathisia) and postural hypotension and no pattern of laboratory abnormalities or apparent weight gain. Ziprasidone-treated patients were not clinically different from placebo-treated patients on the Simpson-Angus Rating scale, Barnes Akathisia scale and AIMS assessments. These results indicate that ziprasidone 120 mg/day is effective in the treatment of the positive, negative and affective symptoms of schizophrenia and schizoaffective disorder with a very low side-effect burden.