利培酮口服液合并氯硝西泮片治疗精神分裂症急性激越的对照研究

目的:比较利培酮口服液合并氯硝西泮片与氟哌啶醇肌内注射治疗精神分裂症急性激越症状的疗效及不良反应。方法:60例精神分裂症急性激越症状患者,按1:1比例随机分入利培酮口服液(2～6mg/d)合并氯硝西泮片(2～8mg/d)组(利培酮组)或氟哌啶醇肌注(5～20mg/d)组(氟哌啶醇组)治疗,疗程7d。采用阳性和阴性症状量表(PANSS)、阳性和阴性症状量表兴奋因子(PANSS-EC)、病人合作程度评定表、修改版外显攻击行为量表(MOAS)、临床疗效总体评定量表(CGI)评定疗效,采用治疗中出现的症状量表(TESS)、静坐不能评定量表(BAS)、锥体外系副反应量表(SAS),不良事件和实验室检查评定安全性。结果:在治疗7d后,利培酮组和氟哌啶醇组PANSS-EC评分分别为(11.1,3.6)分和(12.9,5.2)分,较治疗前均明显进步(P<0.01),两组间PANSS-EC和PANSS总分差异无统计学意义(P>0.05);利培酮组在阳性因子分、MOAS、合作程度改善方面均优于氟哌啶醇组(P<0.05);肌强直、静坐不能的发生率显著低于氟哌啶醇肌注组(P<0.01)。结论:利培酮口服液合并氯硝西泮片治疗精神分裂症急性激越症状与氟哌啶醇肌内注射疗效相当,在某些方面优于氟哌啶醇肌内注射。

A controlled study of risperidone oral solution combine with clonazepam tablet in the treatment of acute agitation in patients with schizophrenia

Objective:To compare the efficacy and safety of risperidone oral solution combined with clonazepam tablet versus haloperidol intramuscular treatment in the treatment of acute agitation in patients with schizophrenia.Method:A total of 60 schizophrenic patients with acute agitation were equally randomly assigned to receive either risperidone oral solution(2-6 mg/d) and clonazepam tablets(2-8 mg/d)(RIS) or haloperidol intramuscular injection treatment(10-20 mg/d)(HAL) for 7 days.The efficacy outcome was measured by using the positive and negative syndrome scale(PANSS),the positive and negative syndrome scale excited component(PANSS-EC),the assessment of patients’ cooperation,the modified overt aggression scale(MOAS) and the clinical global impression scale(CGI).Safety was evaluated by using the Simpson-Angus rating scale(SAS),the Barnes Akathisia scale(BAS),the treatment emergent symptom scale(TESS),adverse events and lab tests.Results:At the end of study,the mean scores of PANSS-EC were(11.1,3.6) and(12.9,5.2)respectively in RIS and HAL,with the significant reduction from baseline(P>0.05).There were no differences of the PANSS-EC scores and the total PANSS scores between two groups(P>0.05).The improvements of the PANSS positive scores,the MOAS scores and the assessment of patients’ cooperation scores were significant higher in RIS than in HAL(P<0.05).The rates of myotonia and akathisia in RIS were significantly lower than in HAL(P<0.01).Conclusion:The efficacy of risperidone oral solution combined with clonazepam tablet in the treatment of acute agitation in patients with schizophrenia is comparable to haloperidol intramuscular treatment.Treatment with risperidone oral solution combine with clonazepam tablet does better in controlling positive symptoms,aggressive behavior,compliance and tolerability than haloperidol intramuscular treatment.