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在私人诊所使用催眠药物进行双盲多中心研究时存在的问题。

Problems in performing a double-blind multicenter study using a hypnotic in private practice.

作者信息

Fischer W, Haase W, Rüther E, Clarenbach P, Hajak G

机构信息

Rhône-Poulenc Rorer GmbH, Cologne, Germany.

出版信息

Int J Clin Pharmacol Ther Toxicol. 1992 Nov;30(11):474.

PMID:1490788
Abstract
  1. The procedure described--the immediate data transfer and entry system (ITES)--is suitable to improve the quality of data collected in multicentre studies in private practice. 2. The results of the study show that regarding influence on sleep quality and daytime well-being the non-benzodiazepine Z is significantly superior to placebo and slightly superior to the benzodiazepines F and T. 3. The advantage of Z treatment is the better daytime well-being after taking the hypnotic for sleep induction the night before. 4. This study shows that a quality standard equal to that in clinical practice may be achieved in private practice.
摘要
  1. 所描述的程序——即时数据传输与录入系统(ITES)——适用于提高私人诊所多中心研究中所收集数据的质量。2. 研究结果表明,就对睡眠质量和日间幸福感的影响而言,非苯二氮䓬类药物Z显著优于安慰剂,略优于苯二氮䓬类药物F和T。3. Z治疗的优势在于,在前一晚服用催眠药诱导睡眠后,日间幸福感更佳。4. 这项研究表明,私人诊所可以实现与临床实践相当的质量标准。

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