利培酮口服液合并氯硝西泮与氟哌啶醇肌注后换用利培酮口服液临床对照研究

Randomized Controlled Study on Combination Treatment with Oral Risperidone and Clonazepam versus Initial Treatment with Intramuscular Haloperidol Followed by Oral Risperidone

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65例兴奋激越的精神分裂症患者:33例随机分入研究组,利培酮口服液(2～6m/d)合并氯硝西泮(2～4mg/d),第8天起氯硝西泮逐渐减量,共观察49d;32例分入对照组,前7天氟哌啶醇肌注(10～20mg/d),第8天起逐渐替换为利培酮口服液(2～6ml/d),共观察49d。以阳性与阴性症状量表(PANSS)及兴奋激越项目(PANSS-EC)和治疗中出现的症状量表(TESS)评定疗效和不良反应,分别在入组时及治疗第7天、第14天、第49天各评定1次。结果两组有效率比较无显著性差异(χ2=0.14,P>0.05)。治疗前后比较,两组PANSS总分从治疗第7天起下降有显著性差异(t=2.27,2.39;P均<0.05),从治疗第14天起下降有非常显著性差异(t=3.40,4.30;P均<0.01);两组PANSS-EC评分从治疗第7天起下降并有非常显著性差异(t=7.01,8.44;P均<0.01);两组治疗同期PANSS总分、PANSS-EC评分比较无显著性差异(t=0.49～1.82;P均>0.05)。研究组肌强直、震颤、静坐不能的发生率均明显低于对照组(χ2=5.63～10.46;P均<0.05)。结论利培酮口服液合并氯硝西泮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用利培酮口服液,也能保持疗效。

Objective To explore the efficacy and safety of psychotic agitation in schizophrenic patients comparing combination treatment with oral risperidone and clonazepam versus initial treatment with intramuscular haloperidol followed by oral risperidone.Methods A total of 63 schizophrenic patients with acute psychotic agitation were randomly assigned to two groups.The 33 subjects in the study group were given 7 days of combined treatment with oral risperidone（2～6mg/d）and clonazepam（2～4mg/d）after which the clonazepam was gradually with drawn and the risperidone was continued for 42 days.The 32 subjects in control group were given 7 days of intramuscular haloperidol（10～20mg/d）followed by 42 days of treatment with oral risperidone（2～6mg/d）.Efficacy and adverse effects were assessed using the Positive and Negative Syndrome Scale（PANSS）,PANSS-EC,Treatment Emergent Symptoms Scale（TESS）before treatment and at the end of 7 th,14th,49th day after treatment.Results There were no significant diferences in the efficacy between two groups（χ2=0.14,P0.05）.The two groups showed significant decreases on PANSS at the end of 7th day after treatment（t=2.27,2.39;P0.05）.The two groups showed very significant decreases on PANSS at the end of 14th day after treatment（t=3.40,4.30;P0.01）.The two groups showed very significant decreases on PANSS-EC at the end of 7th day after treatment（t=7.01,8.44;P0.01）.and no significant differences were found between two groups（t=0.49～1.82;P0.05）.They were different in the side effects such as extrapyramidal reactions（χ2=5.63～10.46;P0.05）.Conclusion Combined treatment with oral risperidone and 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.