Gelders Y G, Heylen S L, Vanden Bussche G, Reyntjens A J, Janssen P A
Department of Clinical Research and Development, Janssen Research Foundation, Beerse, Belgium.
Pharmacopsychiatry. 1990 Sep;23(5):206-11. doi: 10.1055/s-2007-1014509.
Sixty-one adult psychotic patients were treated for four weeks in an open dose-finding study with the new combined serotonin-dopamine antagonist risperidone (R 64 766). Risperidone had a rapid onset of action; a highly significant decrease in the total score on the Brief Psychiatric Rating Scale (BPRS) was already noticed after the first week of treatment. There was also a significant decrease in score for individual BPRS items related to positive, negative, and affective symptoms. In spite of the withdrawal of antiparkinson medication at selection, a significant decrease in extra-pyramidal symptoms (EPS) was observed, as assessed on the Simpson and Angus Scale. The Clinical Global Impression of therapeutic effect was consistent with the BPRS scores, showing a constant improvement throughout the study. The mean daily dose of risperidone at the end of the study was 3.7 mg. Tolerance was excellent and only mild side-effects were reported. Vital signs, ECG-parameters, and laboratory values remained within normal limits. This study demonstrates that risperidone has great potential as an effective and well-tolerated alternative for the treatment of chronically psychotic patients. It has potent antipsychotic effects, a low EPS-inducing profile, and, at the same time, it improves the negative and affective symptoms of schizophrenia.
在一项开放性剂量探索研究中，61名成年精神病患者接受了新型5-羟色胺-多巴胺复合拮抗剂利培酮（R 64 766）为期四周的治疗。利培酮起效迅速；在治疗第一周后，简明精神病评定量表（BPRS）总分就已出现极显著下降。与阳性、阴性及情感症状相关的各个BPRS项目得分也显著下降。尽管在入选时停用了抗帕金森药物，但根据辛普森和安格斯量表评估，锥体外系症状（EPS）仍显著减少。治疗效果的临床总体印象与BPRS评分一致，在整个研究过程中持续改善。研究结束时利培酮的日均剂量为3.7毫克。耐受性良好，仅报告了轻微的副作用。生命体征、心电图参数及实验室值均保持在正常范围内。这项研究表明，利培酮作为治疗慢性精神病患者的一种有效且耐受性良好的替代药物具有巨大潜力。它具有强效的抗精神病作用，诱发EPS的可能性低，同时还能改善精神分裂症的阴性及情感症状。
