Claus A, Bollen J, De Cuyper H, Eneman M, Malfroid M, Peuskens J, Heylen S
University Psychiatric Hospital St. Kamillus, Bierbeek, Belgium.
Acta Psychiatr Scand. 1992 Apr;85(4):295-305. doi: 10.1111/j.1600-0447.1992.tb01473.x.
Forty-four chronic schizophrenic inpatients participated in this multicentre 12-week parallel-group double-blind trial. After a run-in period of 2 weeks and a single-blind placebo wash-out of 1 week, they were randomly assigned to treatment with either the serotonin2 and dopamine-D2 antagonist risperidone or haloperidol. Two patients were excluded from the efficacy analysis. Five patients dropped out in the haloperidol group and 1 in the risperidone group. At the end of the trial, the mean daily dose was 12 mg for risperidone and 10 mg for haloperidol. The risperidone group showed greater improvement on the Positive and Negative Syndrome Scale for Schizophrenia, the Schedule for Affective Disorders and Schizophrenia-change version, and the Nurses' Observation Scale for Inpatient Evaluation. The improvement of negative symptoms was more pronounced in the risperidone group until week 8 of double-blind treatment. The consumption of antiparkinsonian medication was 10 times lower with risperidone. Both drugs were well tolerated and the laboratory, endocrinological and cardiovascular safety parameters were comparable. This study suggests that risperidone is comparable to haloperidol as an antipsychotic, but that it has a safer EPS profile.
44名慢性精神分裂症住院患者参与了这项多中心、为期12周的平行组双盲试验。经过2周的导入期和1周的单盲安慰剂洗脱期后，他们被随机分配接受5-羟色胺2和多巴胺-D2拮抗剂利培酮或氟哌啶醇治疗。两名患者被排除在疗效分析之外。氟哌啶醇组有5名患者退出，利培酮组有1名患者退出。试验结束时，利培酮的平均日剂量为12毫克，氟哌啶醇为10毫克。利培酮组在精神分裂症阳性和阴性症状量表、情感障碍和精神分裂症变化版日程表以及护士住院患者评估观察量表上显示出更大的改善。在双盲治疗的第8周之前，利培酮组阴性症状的改善更为明显。使用利培酮时，抗帕金森药物的消耗量低10倍。两种药物耐受性良好，实验室、内分泌和心血管安全参数相当。这项研究表明，利培酮作为一种抗精神病药物与氟哌啶醇相当，但它的锥体外系反应谱更安全。
