利培酮合并氯硝西泮治疗精神分裂症急性兴奋的研究

目的 与氯氮平和氟哌啶醇相对照,观察利培酮合并氯硝西泮治疗精神分裂症急性兴奋的疗效及不良反应特点。方法 254例精神分裂症急性期中度兴奋患者,随机分为口服利培酮合并肌内注射氯硝西泮组(88例,以下简称利培酮组)、口服氯氮平组(84例,氯氮平组)和肌内注射氟哌啶醇组(82例,氟哌啶醇组)治疗,疗程均为7 d。治疗期间每日评估阳性和阴性症状量表(PANSS)兴奋因子(PANSS-EC)和治疗中需处理的不良反应量表。结果 利培酮组的疗效与氯氮平组、氟哌啶醇组比较,经重复测量分析显示PANSS-EC分,差异无显著性(F=1.65,P=0.194)。3组精神分裂症患者的急性兴奋症状均获明显改善(各组组内治疗前后比较,F=415.35,P<0.01)。氟哌啶醇组锥体外系副反应发生率高于利培酮组和氯氮平组(P<0.01);氯氮平组嗜睡、便秘、流涎和心动过速的发生率高于利培酮组和氟哌啶醇组(P<0.05-0.01)。结论 利培酮合并氯硝西泮可有效治疗精神分裂症急性期中度兴奋患者,疗效与氯氮平和氟哌啶醇的疗效相当;安全性优于氯氮平和氟哌啶醇。

A multicenter study of risperidone treatment for acute agitation in patients with schizophrenia

Objective This study was to investigate the efficacy and adverse effect profiles of risperidone combined with clonazepam versus clozapine and haloperidol for treatment of acute agitation in schizophrenia. Methods A total of 254 schizophrenics with moderate acute agitation was randomized to receive risperidone combined with clonazepam, clozapine. and intramuscular haloperidol treatment for 7 days. The patients were simultaneously assessed with the Positive and Negative Syndrome Scale Excited Components (PANSS-EC) and Treatment Emergent Signs and Symptoms (TESS) every day. Results The efficacy of risperidone combined with clonazepam was comparable to clozapine and intramuscular haloperidol ( F = 1. 65 , P > 0. 05). Acute agitation in schizophrenia was significantly improved within each group ( F = 415.35, P < 0. 01 ). There was a significantly greater incidence of extrapyramidal side-effects with haloperidol than those with risperidone and clozapine, while clozapine significantly induced more drowsiness, constipation, salivation and tachycardia than other groups (P<0. 05 -0.01). Conclusions Risperidone combined with clonazepam is efficacious for acute agitation in schizophrenia, with superior safety profile over clozapine and intramuscular haloperidol.