Heikkilä L, Eliander H, Vartiainen H, Turunen M, Pedersen V
Uusikaupunki Hospital, Finland.
Curr Med Res Opin. 1992;12(9):594-603. doi: 10.1185/03007999209111526.
A double-blind, multi-centre study was carried out in 49 hospitalized patients with an acute psychosis or an exacerbation of a chronic psychosis to compare the wanted and unwanted effects of the neuroleptics, zuclopenthixol and haloperidol. Patients were allocated at random to receive treatment with one or other of the trial drugs for 8 weeks or until discharge. Five patients on zuclopenthixol and 6 on haloperidol were excluded from the efficacy analyses because they did not complete a minimum of 4-weeks' treatment. Dosage was chosen and adjusted to the individual patient's condition and response. The average daily doses in Week 4 were 33.5 mg and 10.3 mg, respectively. Clinical assessments, including CGI, BPRS and the UKU side-effect scale, were done at baseline, and after 1, 2, 4, 6 and 8 weeks of treatment or at discharge if the patient was discharged earlier than Week 8. Both treatments caused a significant reduction in scores with no between-group differences. More patients in the zuclopenthixol group were discharged early indicating slightly more rapid onset of action. Zuclopenthixol caused a significantly greater improvement in 'anxious-depression' factor score than haloperidol. The most frequent unwanted effects were extrapyramidal symptoms and there were no significant differences between the groups. The extrapyramidal symptoms tended to be transient in the zuclopenthixol group, but not in the haloperidol group. The study confirmed that both zuclopenthixol and haloperidol were effective drugs in the treatment of acute, psychotic patients. There was a trend towards a slightly more rapid onset of effect and a somewhat stronger anxiolytic-antidepressant effect by zuclopenthixol compared to haloperidol.
对49例急性精神病患者或慢性精神病急性发作的住院患者进行了一项双盲、多中心研究，以比较神经阻滞剂珠氯噻醇和氟哌啶醇的疗效和不良反应。患者被随机分配接受其中一种试验药物治疗8周或直至出院。5例接受珠氯噻醇治疗的患者和6例接受氟哌啶醇治疗的患者被排除在疗效分析之外，因为他们未完成至少4周的治疗。根据个体患者的病情和反应选择并调整剂量。第4周的平均日剂量分别为33.5毫克和10.3毫克。在基线时以及治疗1、2、4、6和8周后或如果患者在第8周之前出院，则在出院时进行临床评估，包括临床总体印象量表（CGI）、简明精神病评定量表（BPRS）和UKU副作用量表。两种治疗均使评分显著降低，组间无差异。珠氯噻醇组更多患者提前出院，表明起效略快。珠氯噻醇在“焦虑抑郁”因子评分方面的改善明显大于氟哌啶醇。最常见的不良反应是锥体外系症状，两组之间无显著差异。锥体外系症状在珠氯噻醇组往往是短暂的，但在氟哌啶醇组不是。该研究证实，珠氯噻醇和氟哌啶醇都是治疗急性精神病患者的有效药物。与氟哌啶醇相比，珠氯噻醇有起效略快和抗焦虑-抗抑郁作用略强的趋势。
