Den Boer J A, Ravelli D P, Huisman J, Ohrvik J, Verhoeven W M, Westenberg H G
University Hospital, Department of Biological Psychiatry, Utrecht, The Netherlands.
Psychopharmacology (Berl). 1990;102(1):76-84. doi: 10.1007/BF02245748.
In the present 6-week double-blind, randomised, multicentre study, the atypical neuroleptic remoxipride was compared to haloperidol in acute schizophrenic patients (DSM-III). Seventy-one patients entered the study, 36 in the remoxipride group and 35 in the haloperidol group. There were ten early withdrawals, four in the remoxipride group and six patients in the haloperidol group. The Present State Examination (PSE) profile revealed a similar reduction in the symptom clusters of psychosis in both treatment groups. Forty-seven per cent of the patients in the remoxipride group and 34% of the patients in the haloperidol group showed clinically relevant improvement (reduction of BPRS total score greater than or equal to 50%). All extrapyramidal symptoms except "glabella tap" occurred significantly less frequently in the remoxipride group as compared to the haloperidol group. Substantially lower incidences of EPS were found by active questioning in the remoxipride group compared to the haloperidol group. In addition, considerably lower incidences were observed in the remoxipride group with respect to drowsiness/somnolence, tiredness/fatigue and concentrating difficulty. At the end of treatment 66% of the patients in the haloperidol group and 22% in the remoxipride group were using anticholinergics. No consistent changes were found in the mean plasma HVA level in either treatment group. In responders (reduction of BPRS total score greater than or equal to 50%) lower baseline HVA levels were observed in both treatment groups. This study indicates that the newly developed neuroleptic remoxipride is an effective antipsychotic compound, which is clinically safe and well tolerated. In particular, few EPS were induced by remoxipride, as compared to haloperidol.
在目前这项为期6周的双盲、随机、多中心研究中，将非典型抗精神病药物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。71名患者进入研究，瑞莫必利组36例，氟哌啶醇组35例。有10例提前退出，瑞莫必利组4例，氟哌啶醇组6例。现况检查（PSE）结果显示，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总分降低大于或等于50%）。与氟哌啶醇组相比，瑞莫必利组除“眉间轻叩”外的所有锥体外系症状出现频率均显著较低。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，瑞莫必利组在嗜睡/昏睡、疲倦/疲劳和注意力集中困难方面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%的患者使用抗胆碱能药物。两个治疗组的平均血浆高香草酸（HVA）水平均未发现一致变化。在有反应者（BPRS总分降低大于或等于50%）中，两个治疗组的基线HVA水平均较低。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的抗精神病化合物，临床安全性好且耐受性佳。特别是，与氟哌啶醇相比，瑞莫必利引起的EPS较少。
