利培酮合并氯硝西泮口服与氟哌啶醇肌注后换利培酮口服治疗精神分裂症兴奋激越症状的随机对照研究

目的比较利培酮口服液合并氯硝西泮片与氟哌啶醇肌注控制精神分裂症兴奋激越症状的疗效和安全性,以及在兴奋激越控制后以利培酮口服液替换氟哌啶醇肌注的疗效及安全性。方法纳入33例兴奋激越的精神分裂症患者：18例随机分入利培酮组,利培酮口服液（2～6ml/d）合并氯硝西泮（4～8mg/d）,第6天起氯硝西泮逐渐减量,共观察47d;15例分入氟哌啶醇组,前5天氟哌啶醇肌注（10～20mg/d）,第6天起逐渐替换为利培酮口服液（2～6ml/d）,共观察47d。以阳性与阴性综合征量表（PANSS）、Barnes静坐不能量表（BAS）,类帕金森综合征量表（SAS）评定疗效和不良反应。结果第5天末利培酮组和氟哌啶醇组PANSS兴奋激越因子分的平均（标准差）减分值分别为6.9（3.8）分,8.2（4.7）分,t=0.85,P=0.403,PANSS总分平均减分值分别为41.1（13.5）分,47.7（14.2）分,t=1.31,P=0.199。第5天末利培酮组的SAS评分低于氟哌啶醇肌注组分别为0（0）分,2（9）分,Z=2.72,P=0.006]。结论利培酮口服液合并氯硝西泮片剂可有效安全地治疗精神分裂症急性兴奋激越。用氟哌啶醇肌注控制兴奋激越后直接换利培酮口服液,也能保持疗效。

Randomized controlled study of psychotic agitation in schizophrenic patients comparing combination treatment with oral risperidone and clonazepam versus initial treatment with intramuscular haloperidol followed by oral risperidone

Background：Psychotic agitation in schizophrenia is an emergency but available treatments are not optimal. Methods： 33 schizophrenic patients with acute psychotic agitation were randomly assigned to two groups. The 18 subjects in the first group were given 5 days of combined treatment with risperidone oral concentrate （2-6 mg/d） and clonazepam （4-6 mg/d） after which the clonazepam was gradually withdrawn and the risperidone was continued for 42 day. The 15 subjects in the second group were given 5 days of intramuscular haloperidol （10-20 mg/d） followed by 42 days of treatment with risperidone oral concentrate （2-6 mg/d）. Efficacy and adverse effects were assessed using the Positive and Negative Syndrome Scale （PANSS）, Simpson-Angus Scale （SAS）, and Barnes Akathisia Scale （BAS）. Results：At the end of the first 5 days of treatment the mean （sd） change in scores on the Excitement subscale of the PANSS were 6.9 （3.8） in the oral group and 8.2 （4.7） in the haloperidol group （t=0.85, P=0.403）; the mean change scores of the total PANSS were 41.1 （13.5） versus 47.7 （14.2）, respectively （t=1.31, P=0.199）. On the 5th day of treatment the mean SAS score was lower in the resperidone group than in the haloperidol group 0 （0） vs 2 （9）, Z=2.72, P=0.006]. Conclusion：Combined treatment with risperidone oral concentrate and oral clonazepam is as effective as intramuscular haloperidol in the acute management of psychotic agitation in schizophrenic patients and is associated with less severe side effects.