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开放试验和双盲试验的临床经验。

Clinical experiences in an open and a double-blind trial.

作者信息

Pöldinger W

出版信息

Acta Psychiatr Belg. 1978 Jan-Feb;78(1):96-101.

PMID:347884
Abstract

A total of sixty patients were trated with bromperidol first in open conditions (20 patients), then on a double blind basis (40 patients) with haloperidol as the reference substance. The open study lasted for four weeks; the drug was administrated in the form of 1 mg tablets. The daily dose (initial dose: 1 mg; mean dose at the end of the trial: 4.47 mg) was always administered in one single dose. Nineteen patients finished the trial, and in 18 cases the therapeutic result was considered very good to good. These results were confirmed by statistical analysis. Nine patients exhibited mild to moderate extrapyramidal concomitant symptoms; no other side effects were observed. The results of detailed laboratory tests and evaluations of various quantitative and qualitative tolerability parameters were not indicative of toxic effects. In the double blind study with haloperidol, both substances were found to be highly effective in the treatment of psychotic syndromes belonging predominantly to the schizophrenia group. Certain clues, including the onset of action, seem to be indicative of the superiority of bromperidol. No differences were observed with respect to side effects and general tolerability.

摘要

共有60名患者首先在开放条件下接受溴哌利多治疗(20名患者),然后以氟哌啶醇作为对照物质,在双盲基础上接受治疗(40名患者)。开放研究持续了四周;药物以1毫克片剂的形式给药。每日剂量(初始剂量:1毫克;试验结束时的平均剂量:4.47毫克)总是单次给药。19名患者完成了试验,18例的治疗结果被认为非常好或良好。这些结果通过统计分析得到证实。9名患者出现轻度至中度锥体外系伴随症状;未观察到其他副作用。详细的实验室检查结果以及对各种定量和定性耐受性参数的评估未显示出毒性作用。在与氟哌啶醇的双盲研究中,发现两种物质在治疗主要属于精神分裂症组的精神综合征方面都非常有效。某些线索,包括起效时间,似乎表明溴哌利多更具优势。在副作用和总体耐受性方面未观察到差异。

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