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卡比咪嗪/安慰剂双盲临床研究(作者译)

[Double-blind clinical study of carpipramine/placebo (author's transl)].

作者信息

Eckmann F

出版信息

Arzneimittelforschung. 1976;26(12):2224-6.

PMID:14651
Abstract

A statistically planned double blind cross-over test with the substances 1-[3-(10,11-dihydro-5H-dibenz[b;f]-azepin-5-yl)-propyl]-4-piperidino-piperidine-4-carboxamide dihydrochloride-monohydrate (carpipramine, BAY b 4343 b) and placebo (BAY b 4343 a) was carried out on 30 long-term hospitalized schizophrenic patients. The study was evaluated by means of the kappa2-test and yielded the following results: 1. It could be statistically proved that carpipramine has a positive effect on psycho-pathological disorders in the behaviour of long-term hospitalized schizophrenic patients (kappa2 = 9.224; FG = 1; p greater than 0.05). 2. As regards the favourable influence of carpipramine on "productive" versus "non-productive" form of schizophrenia there were no differences. 3. Side effects or complications of a psychic, autonomic and/or motoric manner could not be seen. The usual laboratory tests showed no deviation from normal.

摘要

对30名长期住院的精神分裂症患者进行了一项统计设计的双盲交叉试验,使用的药物为1-[3-(10,11-二氢-5H-二苯并[b;f]氮杂卓-5-基)-丙基]-4-哌啶基-哌啶-4-甲酰胺二盐酸盐-一水合物(卡比咪嗪,BAY b 4343 b)和安慰剂(BAY b 4343 a)。该研究通过kappa2检验进行评估,结果如下:1. 统计学上可以证明,卡比咪嗪对长期住院精神分裂症患者的行为心理病理障碍有积极作用(kappa2 = 9.224;自由度 = 1;p大于0.05)。2. 卡比咪嗪对精神分裂症“阳性”与“阴性”形式的有利影响没有差异。3. 未观察到精神、自主神经和/或运动方面的副作用或并发症。常规实验室检查未显示与正常情况有偏差。

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