利培酮口服液合并氯硝西泮治疗精神分裂症兴奋激越症状的随机对照研究

Randomized Controlled Study on Psychotic Agitation in Schizophrenic Patients Comparing Combination Treatment with Risperidone Oral Solution and Clonazepam

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。方法将65例兴奋激越的精神分裂症患者随机分为利培酮口服液合并氯硝西泮片组（研究组）33例和肌肉注射氟哌啶醇组（对照组）32例治疗,研究组给予利培酮口服液治疗（4~6 mg/d）,同时给予氯硝西泮口服（2~4 mg/d）,对照组给予氟哌啶醇针剂肌肉注射（10~20 mg/d）,疗程7d。以阳性与阴性症状量表（PANSS）及兴奋激越项目（PANSS-EC）和副反应量表（TESS）评定疗效和不良反应。结果两组有效率比较无显著性差异（χ2=0.60,P〉0.05）。两组治疗前后比较,研究组PANSS总分下降有显著性差异（t=2.27,P〈0.05）,PANSS-EC评分下降有非常显著性差异（t=7.01,P〈0.01）;对照组PANSS总分下降有显著性差异（t=2.39,P〈0.05）,PANSS-EC评分下降有非常显著性差异（t=8.44,P〈0.01）。治疗后第7天两组PANSS总分（t=0.63,P〉0.05）和PANSS-EC评分（t=1.62,P〉0.05）比较均无显著性差异。研究组肌强直、震颤、静坐不能的发生率均明显低于对照组（P〈0.05）。结论利培酮口服液合并氯硝西泮治疗精神分裂症兴奋激越症状的疗效肯定,不良反应较轻,值得临床推广应用。

Objective To compare curative effect and safety of combination treatment with risperidone oral solution and clonazepam to combination treatment with haloperidol.Methods A total of 65 schizophrenic patients with acute psychotic agitation were randomly assigned to two groups.The 33 subjects in the study group were given risperidone oral solution（4～6mg/d）and clonazepam（2～4mg/d）,the control group were given haloperidol.The course of treatments were 7 days.Efficacy and adverse effects were assessed using the Positive and Negative Syndrome Scale（PANSS）,PANSS-EC,and treatment emergent symptom scale（TESS）.Results There was no significant difference between two groups in effectiveness rate（χ2=0.60,P〉0.05）.The PANSS total score of study group decreased significantly after the treatment（t=2.27,P〈0.05）,the PANSS-EC scores decreased significantly（t=7.01,P〈0.01）.The PANSS total score of the control group decreased significantly after the treatment（t=2.39,P〈0.05）,the PANSS-EC scores decreased significantly（t=8.44,P〈0.01）,and no significant difference was found between two groups in The PANSS total score（t=0.63,P〉0.05）and the PANSS-EC score（t=1.62,P〉0.05）.the incidence rate of myotonia,chatter and cathisophobia in study group were significantly lower than those in control group（P〈0.05）.Conclusion Combined treatment with risperidone oral solution 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.It can be spread in clinic.