注射用甲磺酸齐拉西酮治疗精神分裂症兴奋躁动状态的Ⅱ期临床试验  

The second phase clinical trials of intramuscular Ziprasidone for the treatment of acute psychotic agitation of the schizophrenia

作　　者：王继才[1] 许秀峰[1] 欧阳虹[1] 李文昱[1] 

机构地区：[1]昆明医学院第一附属医院精神科,650032

出　　处：《神经疾病与精神卫生》2007年第5期364-370,共7页Journal of Neuroscience and Mental Health

摘　　要：目的评价注射用甲磺酸齐拉西酮治疗精神分裂症兴奋躁动状态的疗效和安全性。方法采用随机、盲法、氟哌啶醇注射液平行对照的方法,对符合《CCMD-3》精神分裂症或分裂样精神病诊断标准的32例患者进行齐拉西酮的研究;其中齐拉西酮组16例(20～40mg/d),氟哌啶醇组16例(10～20mg/d),共治疗3d。采用PANSS-EC、ACES、CGI评定临床疗效,AE、RSESE、BAS评定不良反应。结果经3d治疗后,齐拉西酮组有效率为87.5%,氟哌啶醇组为87.5%,差异无显著性(P>0.05)。2组的PANSS-EC,ACES评分治疗前后相比差异有高度显著性(P<0.001)。两药均可快速有效的控制急性激越兴奋症状。不良反应分析,氟哌啶醇组的AE、EPS及肝功能异常的发生率显著高于齐拉西酮组,有显著性差异(P<0.001),齐拉西酮组常见的不良反应有头昏、嗜睡、心悸等,未见QTc间期延长。结论注射用甲磺酸齐拉西酮治疗精神分裂症兴奋躁动状态疗效好,不良反应少而轻,适合临床应用。Objective To evaluate the efficacy and safety of intramuscular ziprasidone for the treatment of acute psychotic agitation of the schizophrenia. Methods Controlled with haloperidol injection, A randomized, blind clinical trials was carried out to 32 patients who met the CCMD-3 criteria of schizophrenia or schizophrenia form psychosis. The 16 of total patients were treated with intramuscular ziprasidone （20-40mg/d） and the others were treated with haloperidol injection （10-20mg/d） for 3 days. The efficacy was assessed by changes in scores on the Positive and Negative Syndrome Scale Excited Component （PANSS-EC）, Agitation Calmness Evaluation Scale （ACES）, Clinical Global Impression （CGI） and the safety was assessed by adverse event Scale （AE）, Rating Scale for Extrapyramidal Side Effect （RSESE）, Barnes Akathisia Scale （BAS）. Results After 3 days treatment, the improvement rate of intramuscular ziprasidone treated group and haloperidol injection treated group were 87.5% and 87.5%, respectively （P 〉 0.05） . The scores of PANSS-EC, ACES in two groups were significant differences before and after treatment （P 〈 0. 001） . Both groups rapidly reduced symptoms of acute agitation. The main adverse events of intramuscular ziprasidone were dizziness, somnolence, palpitation, et al. QTc interval prolongation was not revealed in the intramuscular ziprasidone group. There were significant differences in incidence of AE, EPS and Hepatic disfunction between two groups. Conclusions Intramuscular ziprasidone shows efficacy, low liability for side-effects, good tolerability in the treatment of acute psychotic agitation of the schizophrenia, suiting for clinical use.

关 键 词：精神分裂症 注射用齐拉西酮 氟哌啶醇注射液 随机对照试验 疗效 安全性 

分 类 号：R749.3[医药卫生—神经病学与精神病学]