|Double-blind comparison of ziprasidone and risperidone in the treatment of Chinese patients with acute exacerbation of schizophrenia|
|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|
|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|
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.
|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
|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.|
|APA||Zhang, Hongyan.,Li, Huafang.,Shu, Liang.,Gu, Niufan.,Wang, Gang.,...&Schou, Manjula.(2011).Double-blind comparison of ziprasidone and risperidone in the treatment of Chinese patients with acute exacerbation of schizophrenia.NEUROPSYCHIATRIC DISEASE AND TREATMENT,7,77-85.|
|MLA||Zhang, Hongyan,et al."Double-blind comparison of ziprasidone and risperidone in the treatment of Chinese patients with acute exacerbation of schizophrenia".NEUROPSYCHIATRIC DISEASE AND TREATMENT 7(2011):77-85.|