A Canadian multicenter placebo-controlled study of fixed doses of risperidone and haloperidol in the treatment of chronic schizophrenic patients.
A Canadian multicenter placebo-controlled study of fixed doses of risperidone and haloperidol in the treatment of chronic schizophrenic patients.
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加拿大的一项多中心安慰剂对照研究，研究固定剂量的利培酮和氟哌啶醇治疗慢性精神分裂症患者。
DOI：
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发表时间：
1993
影响因子：
2.9
通讯作者：
W. Arnott
中科院分区：
文献类型：
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作者：
G. Chouinard;B. Jones;G. Remington;D. Bloom;D. Addington;G. Macewan;A. Labelle;L. Beauclair;W. Arnott
在一项双盲研究中，135名诊断为慢性精神分裂症的住院患者被随机分配到6种平行治疗之一的8周治疗组：利培酮（一种新的中枢5-羟色胺2和多巴胺D2拮抗剂），2，6，10，16 mg/天;氟哌啶醇，20 mg/天;或安慰剂，在单盲安慰剂洗脱期后。剂量以固定增量增加，直至1周后达到固定维持剂量。在临床疗效总评量表-疾病严重程度和改善方面，除利培酮（2 mg）外，所有活性药物在临床疗效总评量表-改善方面均上级安慰剂。在阳性和阴性症状量表（PANSS）总分和阳性子量表方面，除氟哌啶醇和利培酮（2 mg）外，所有治疗组均观察到优于安慰剂，氟哌啶醇和利培酮（2 mg）在总PANSS和阳性子量表方面分别上级安慰剂。在PANSS阴性子量表上，仅利培酮（6 mg/天）显著优于安慰剂。在总PANSS、一般精神病理学和简明精神病评定量表子量表方面，利培酮（6 mg）上级优于氟哌啶醇。虽然帕金森症随利培酮剂量增加呈线性增加，但利培酮（2、6和16 mg/天）与安慰剂之间无统计学显著差异。在6至16 mg剂量下，与安慰剂相比，利培酮显示出显著的抗运动障碍作用。这种效果在严重运动障碍的患者中更为明显。相比之下，氟哌啶醇比安慰剂和利培酮（2，6和16 mg）产生更多的帕金森症，对迟发性运动障碍没有影响。这些数据表明，利培酮，在最佳治疗剂量为6毫克/天，产生了显着改善阳性和阴性症状，而不增加药物诱导的帕金森症状，并与迟发性运动障碍具有显着的有益效果。
In a double-blind study, 135 inpatients with a diagnosis of chronic schizophrenia were randomly assigned to 8 weeks of treatment with one of six parallel treatments: risperidone (a new central 5-hydroxytryptamine2 and dopamine D2 antagonist), 2, 6, 10, 16 mg/day; haloperidol, 20 mg/day; or placebo, after a single-blind placebo washout period. Doses were increased in fixed increments up to a fixed maintenance dose reached after 1 week. On the Clinical Global Impression-Severity of Illness and Improvement, all active medications were superior to placebo except for risperidone (2 mg) on the Clinical Global Impression-Improvement. On the total Positive and Negative Syndrome Scale (PANSS) score and positive subscale, superiority to placebo was observed for all treatment groups except for haloperidol and risperidone (2 mg), which tended to be superior to placebo on total PANSS and the positive subscale, respectively. On the PANSS negative subscale, only risperidone (6 mg/day) was significantly better than placebo. Risperidone (6 mg) was superior to haloperidol on the total PANSS, General Psychopathology, and Brief Psychiatric Rating Scale subscales. Although there was a linear increase in parkinsonism with increasing risperidone dosage, there were no statistically significant differences between risperidone (2, 6, and 16 mg/day) and placebo. At doses of 6 to 16 mg, risperidone displayed a marked antidyskinetic effect compared with placebo. This effect was more pronounced in patients with severe dyskinesia. By contrast, haloperidol produced significantly more parkinsonism than placebo and risperidone (2, 6 and 16 mg), with no effect on tardive dyskinesia. These data suggest that risperidone, at the optimal therapeutic dose of 6 mg/day, produced significant improvement in both positive and negative symptoms without an increase in drug-induced parkinsonian symptoms and with a significant beneficial effect on tardive dyskinesia.