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学科主题: 精神卫生
题名:
Double-blind comparison of ziprasidone and risperidone in the treatment of Chinese patients with acute exacerbation of schizophrenia
作者: Zhang, Hongyan1; Li, Huafang2; Shu, Liang1; Gu, Niufan2; Wang, Gang3; Weng, Yongzhen3; Xie, Shiping4; Zhang, Xinbao4; Li, Ting5; Ma, Cui5; Yu, Wei6; Parsons, Bruce7; Schou, Manjula8
关键词: ziprasidone ; risperidone ; schizophrenia
刊名: NEUROPSYCHIATRIC DISEASE AND TREATMENT
发表日期: 2011
DOI: 10.2147/NDT.S16664
卷: 7, 页:77-85
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Clinical Neurology ; Psychiatry
研究领域[WOS]: Neurosciences & Neurology ; Psychiatry
关键词[WOS]: PLACEBO-CONTROLLED TRIAL ; SCHIZOAFFECTIVE DISORDER ; NEUROLEPTIC DOSAGE ; HALOPERIDOL ; EFFICACY ; MULTICENTER ; TOLERABILITY ; OLANZAPINE ; CLOZAPINE ; INPATIENTS
英文摘要:

Background: The aim of the study was to evaluate the efficacy and safety of ziprasidone versus risperidone in Chinese subjects with acute exacerbation of schizophrenia.

Methods: In patients meeting the Chinese Classification of Mental Disorders criteria for schizophrenia and with a Positive and Negative Syndrome Scale (PANSS) total score >= 60 were randomly assigned to six weeks of double-blind treatment with ziprasidone 40-80 mg twice daily or risperidone 1-3 mg bid, flexibly dosed. Noninferiority was demonstrated if the upper limit of the two-sided 95% confidence interval (CI) for the difference in PANSS total score improvement from baseline in the evaluable population was smaller than the prespecified noninferiority margin of 10 units.

Results: The intent-to-treat population comprised 118 ziprasidone-treated and 121 risperidone-treated subjects. Improvement (reduction) from baseline to week 6 in PANSS total score was (-35.6 [95% CI: -38.6, -32.6]) for ziprasidone and (-37.1 [95% CI: -39.9, -34.4]) for risperidone. Noninferiority was demonstrated in the evaluable population with a difference score of 1.5 [95% CI: -2.5, 5.5]. Mean prolactin levels decreased at week 6 compared with baseline for ziprasidone (-3.5 ng/mL), but significantly increased for risperidone (61.1 ng/mL; P < 0.001). More risperidone-treated subjects (14.9%) than ziprasidone-treated subjects (4.2%) reported weight gain >= 7%. Akathisia and somnolence in the ziprasidone group and akathisia and insomnia in the risperidone group were the most common side effects. Treatment-related/treatment-emergent adverse events were reported by 79.7% and 71.1% of ziprasidone-treated and risperidone-treated subjects, respectively.

Conclusion: In Chinese subjects, ziprasidone was as effective as risperidone, with less weight gain and less prolactin elevation.

语种: 英语
项目资助者: Pfizer Inc.
WOS记录号: WOS:000294955100009
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/49922
Appears in Collections:北京大学精神卫生研究所_期刊论文

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作者单位: 1.Peking Univ, Dept Psychiat, Inst Mental Hlth, Beijing 100191, Peoples R China
2.Shanghai Mental Hlth Ctr, Shanghai, Peoples R China
3.Capital Med Univ, Beijing An Ding Hosp, Beijing, Peoples R China
4.Nanjing Brain Hosp, Nanjing, Peoples R China
5.Guangzhou Brain Hosp, Guangzhou, Guangdong, Peoples R China
6.Pfizer China, Beijing, Peoples R China
7.Pfizer Inc, New York, NY USA
8.Pfizer Australia, Sydney, NSW, Australia

Recommended Citation:
Zhang, Hongyan,Li, Huafang,Shu, Liang,et al. Double-blind comparison of ziprasidone and risperidone in the treatment of Chinese patients with acute exacerbation of schizophrenia[J]. NEUROPSYCHIATRIC DISEASE AND TREATMENT,2011,7:77-85.
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