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非典型抗精神病药物治疗急性精神分裂症:瑞莫必利与氟哌啶醇的双盲对照研究

Atypical neuroleptics in acute schizophrenia: a double-blind comparative study of remoxipride and haloperidol.

作者信息

den Boer J A, Westenberg H G

机构信息

University Hospital, Department of Biological Psychiatry, Utrecht, The Netherlands.

出版信息

Psychopharmacol Bull. 1990;26(1):99-107.

PMID:1973547
Abstract

In the present double-blind study comprising 6 weeks, remoxipride was compared with haloperidol in acute schizophrenic patients (DSM-III). Symptoms assessment was performed using the Brief Psychiatric Rating Scale (BPRS), the Clinical Global Impressions (CGI) and the Present State Examination (PSE). Extrapyramidal Symptoms (EPS) were assessed using the Simpson and Angus scale. Side effects were also recorded both by spontaneous reports and by active questioning. Seventy-one patients entered the study, 36 in the remoxipride group and 35 in the haloperidol group. There were 10 dropouts, 4 in the remoxipride group and 6 patients in the haloperidol group. The PSE profile revealed a similar reduction in the symptom clusters of psychosis in both treatment groups. Forty-seven percent of the patients in the remoxipride group and 34 percent of the patients in the haloperidol group showed clinically relevant improvement (reduction of total BPRS score by 50% or more). Similar results were obtained with the CGI. All EPS except "glabella tap" occurred significantly less frequently in the remoxipride group compared to the haloperidol group. Substantially lower incidence of EPS was found by active questioning in the remoxipride group compared to the haloperidol group. Also, considerably lower incidences of drowsiness/somnolence, tiredness/fatigue, and concentrating difficulty were observed in the remoxipride group. At the end of treatment, 66 percent of the patients in the haloperidol group and 22 percent in the remoxipride group were using anticholinergics. This study indicates that the newly developed neuroleptic remoxlpride is an effective, clinically safe, and well tolerated antipsychotic compound. In particular, few EPS were induced by remoxipride, as compared to haloperidol.

摘要

在这项为期6周的双盲研究中,将瑞莫必利与氟哌啶醇用于急性精神分裂症患者(DSM-III)进行比较。使用简明精神病评定量表(BPRS)、临床总体印象量表(CGI)和现状检查(PSE)进行症状评估。使用辛普森和安格斯量表评估锥体外系症状(EPS)。还通过自发报告和主动询问记录副作用。71名患者进入研究,瑞莫必利组36名,氟哌啶醇组35名。有10名退出者,瑞莫必利组4名,氟哌啶醇组6名。PSE分析显示,两个治疗组的精神病症状群均有类似程度的减轻。瑞莫必利组47%的患者和氟哌啶醇组34%的患者显示出临床相关改善(BPRS总分降低50%或更多)。CGI也得到了类似结果。与氟哌啶醇组相比,瑞莫必利组除“眉间轻叩”外的所有EPS发生频率均显著较低。通过主动询问发现,瑞莫必利组的EPS发生率明显低于氟哌啶醇组。此外,瑞莫必利组嗜睡/昏睡、疲倦/疲劳和注意力集中困难的发生率也显著较低。治疗结束时,氟哌啶醇组66%的患者和瑞莫必利组22%的患者正在使用抗胆碱能药物。这项研究表明,新开发的抗精神病药物瑞莫必利是一种有效、临床安全且耐受性良好的抗精神病化合物。特别是,与氟哌啶醇相比,瑞莫必利引起的EPS较少。

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