Efficacy and tolerability of ziprasidone versus risperidone in patients with acute exacerbation of schizophrenia or schizoaffective disorder: An 8-week, double-blind, multicenter trial
Efficacy and tolerability of ziprasidone versus risperidone in patients with acute exacerbation of schizophrenia or schizoaffective disorder: An 8-week, double-blind, multicenter trial
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DOI：
10.4088/jcp.v65n1207
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发表时间：
2004-12-01
影响因子：
5.3
通讯作者：
Romano, SJ
中科院分区：
文献类型：
--
作者：
Addington, DEN;Pantelis, C;Romano, SJ
背景：需要更多的抗精神病药物的正面比较来辨别这些化合物的相对疗效和安全性。因此，我们比较齐拉西酮和利培酮在精神分裂症或分裂情感性障碍急性加重患者中的作用。方法：DSM-III-R型精神分裂症或分裂情情性障碍急性加重患者随机分配双盲治疗组齐拉西酮40 ~ 80mg / d （N=149）或利培酮3 ~ 5mg / d (N=147)，疗程8周。主要疗效指标包括阳性和阴性症状量表（PANSS）总分和临床总体印象-疾病严重程度量表（CGI-S）评分；次要测量包括PANSS负分量量表、cgi -改善量表（CGI-I）和PANSS衍生的简短精神病学评定量表（BPRSd）总和核心项目的得分。安全性评估包括运动障碍评估、实验室检查、心电图、生命体征和体重。疗效分析采用前瞻性定义的可评估患者队列。如果齐拉西酮/利培酮与基线的最小二乘平均变化比值的95%置信区间下限为0.60，则授予治疗等效性。数据是从1995年8月至1997年1月收集的。结果：PANSS总分、CGI-S评分、PANSS负分量量表评分、BPRSd总分和核心项目评分、PANSS总分和CGI-I应答率均具有等效性。两种药物均耐受良好。利培酮表现出明显较高的运动障碍负担（MDB）评分(p
Background: More head-to-head comparisons of antipsychotics are needed to discern the relative efficacy and safety profiles of these compounds. Thus, we compared ziprasidone and risperidone in patients with acute exacerbation of schizophrenia or schizoaffective disorder.Method: Patients with DSM-III-R acute exacerbation of schizophrenia or schizoaffective disorder were randomly assigned to double-blind ziprasidone 40 to 80 mg b.i.d. (N=149) or risperidone 3 to 5 mg b.i.d (N=147) for 8 weeks. Primary efficacy measures included Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions-Severity of Illness scale (CGI-S) score; secondary measures included scores on the PANSS negative subscale, CGI-Improvement scale (CGI-I), and PANSS-derived Brief Psychiatric Rating Scale (BPRSd) total and core items. Safety assessments included movement disorder evaluations, laboratory tests, electrocardiography, vital signs, and body weight. Efficacy analyses employed a prospectively defined Evaluable Patients cohort. Treatment equivalence was conferred if the lower limit of the 95% confidence interval of the ziprasidone/risperidone ratio of least-squares mean change from baseline was >0.60. Data were gathered from August 1995 to January 1997.Results: Equivalence was demonstrated in PANSS total scores, CGI-S scores, PANSS negative subscale scores, BPRSd total and core item scores, and PANSS total and CGI-I responder rates. Both agents were well tolerated. Risperidone exhibited a significantly higher Movement Disorder Burden (MDB) score (p