Kim Sung-Wan, Shin Il-Seon, Kim Jae-Min, Lee Seung-Hyun, Lee Jeong-Hoon, Yoon Bo-Hyun, Yang Su-Jin, Hwang Michael Y, Yoon Jin-Sang
Department of Psychiatry, Chonnam National University Medical School, 5 Hak-dong, Dong-gu, Gwangju 501-746, Republic of Korea.
Prog Neuropsychopharmacol Biol Psychiatry. 2007 Oct 1;31(7):1504-9. doi: 10.1016/j.pnpbp.2007.07.005. Epub 2007 Jul 13.
To determine the effectiveness of amisulpride on depression in patients with schizophrenia, in comparison to risperidone.
In this open-label, 12-week study, patients with stable schizophrenia and a comorbid major or minor depressive episode (DSM-IV) taking risperidone were randomized into a risperidone-continuation group (N = 45) or an amisulpride-switch group (N = 42). The main outcome measures were changes from baseline on the Calgary Depression Scale for Schizophrenia (CDSS) and the Beck Depression Inventory (BDI). Secondary efficacy measures included the Positive and Negative Syndrome Scale (PANSS), and the Global Assessment of Functioning. Safety measures included treatment-emergent adverse events and extrapyramidal symptoms.
The mean dose at endpoint was 4.2 mg/day for risperidone and 458.3 mg/day for amisulpride. Improvements in the CDSS and BDI scores were significantly greater in the amisulpride-switch group than in the risperidone-continuation group at weeks 8 and 12, and at the endpoint. The amisulpride-switch group also showed a significantly greater reduction in the score for the PANSS depression/anxiety factor, and the total score from baseline to endpoint. No significant difference was observed between the two groups for treatment-emergent adverse events or change from baseline for extrapyramidal symptoms.
Switching from risperidone to amisulpride in patients with stable schizophrenia with comorbid depression improved depressive symptoms significantly compared to continuing with risperidone.
与利培酮相比,确定氨磺必利对精神分裂症患者抑郁症状的疗效。
在这项开放标签的12周研究中,将病情稳定且患有共病性重度或轻度抑郁发作(DSM-IV)并正在服用利培酮的精神分裂症患者随机分为利培酮持续治疗组(N = 45)或氨磺必利转换组(N = 42)。主要结局指标为基于卡尔加里精神分裂症抑郁量表(CDSS)和贝克抑郁量表(BDI)从基线起的变化。次要疗效指标包括阳性和阴性症状量表(PANSS)以及总体功能评估。安全性指标包括治疗中出现的不良事件和锥体外系症状。
终点时利培酮的平均剂量为4.2毫克/天,氨磺必利为458.3毫克/天。在第8周、12周及终点时,氨磺必利转换组的CDSS和BDI评分改善显著大于利培酮持续治疗组。氨磺必利转换组的PANSS抑郁/焦虑因子评分以及从基线到终点的总分降低也更为显著。两组在治疗中出现的不良事件或锥体外系症状相对于基线的变化方面未观察到显著差异。
对于患有共病性抑郁的病情稳定的精神分裂症患者,从利培酮转换为氨磺必利相比继续使用利培酮可显著改善抑郁症状。