Nestoros J N, Lehmann H E, Ban T A
Int Pharmacopsychiatry. 1978;13(3):138-50. doi: 10.1159/000468334.
A 16-week, standard-controlled, double-blind study was conducted to compare the efficacy of butaclamol with that of fluphenazine in the treatment of 24 newly admitted schizophrenic patients. Statistically significant improvement occurred in the entire population in the total scores of the BPRS and PAS; in the activation, anergia, thought disturbance and hostile/suspiciousness factor scores of the BPRS; and in the scores of 9 of the 12 factors of the PAS. There were no statistically significant differences between the scores of the two treatment groups on the total or factor scores of either scale during the course of the clinical trial. The most frequently occurring adverse effects in the butaclamol group were rigidity, akathisia and excitement/agitation. The most frequently occurring adverse effects in the fluphenazine group were insomnia, decreased motor activity and tremor. It is concluded that butaclamol exerts potent neuroleptic effects on schizophrenic patients.
开展了一项为期16周的标准对照双盲研究，以比较布他拉莫与氟奋乃静治疗24例新入院精神分裂症患者的疗效。在整个研究人群中，简明精神病评定量表（BPRS）和阳性与阴性症状量表（PAS）的总分有统计学意义的改善；在BPRS的激活、无活力、思维紊乱和敌对/猜疑因子得分方面；以及在PAS的12个因子中的9个因子得分方面。在临床试验过程中，两个治疗组在任一量表的总分或因子得分上均无统计学显著差异。布他拉莫组最常出现的不良反应是强直、静坐不能和兴奋/激越。氟奋乃静组最常出现的不良反应是失眠、运动活动减少和震颤。结论是布他拉莫对精神分裂症患者有显著的抗精神病作用。
