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替氟雷司缓释制剂对人体厌食活性的评估。

An evaluation of the anorectic activity in man of a sustained release formulation of tiflorex.

作者信息

Silverstone T, Fincham J, Plumley J

出版信息

Br J Clin Pharmacol. 1979 Apr;7(4):353-6. doi: 10.1111/j.1365-2125.1979.tb00945.x.

DOI:10.1111/j.1365-2125.1979.tb00945.x
PMID:444355
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1429648/
Abstract

The effects of a slow release form of tiflorex (TFX-SR, formerly known as flutiorex), a new anorectic drug. on subjective measures of hunger, arousal, and mood, and on objective measures of food intake, critical flicker fusion, pupil diameter, pulse rate and blood pressure, were observed in a two-phase placebo-controlled, double-blind trial using six healthy female volunteers. In Phase I of the trial a reduction in hunger after TFX-SR, significant compared with pre-drug values, was observed some five to seven hours after administration; no significant reduction in hunger occurred after placebo. In Phase II, a significant reduction in food intake occurred at a time corresponding to, and slightly later than, the subjective anorectic effect noted in Phase I. TFX-SR produced no effect on pulse rate or blood pressure; it did produce some mydriasis. There was no evidence of CNS stimulation after TFX-SR; the drug had no influence either on critical flicker fusion frequency or psychomotor performance. A reduction in subjective arousal was observed after three hours, but tiflorex caused no other significant change in subjective measures of arousal or mood. Only slight sleep disturbance was reported; subjective reports of headache were more frequent after drug administration than after placebo occurring in seven out of twelve active drug exposures. Side effects were noted on eleven occasions after TFX-SR compared to five occasions after placebo.

摘要

新型食欲抑制剂替氟雷司缓释制剂(TFX-SR,原名氟替雷司)对饥饿、觉醒和情绪主观指标以及食物摄入量、临界闪烁融合频率、瞳孔直径、脉搏率和血压客观指标的影响,在一项使用6名健康女性志愿者的两阶段安慰剂对照双盲试验中进行了观察。在试验的第一阶段,服用TFX-SR后约5至7小时,观察到饥饿感较用药前明显降低;服用安慰剂后饥饿感无明显降低。在第二阶段,食物摄入量在与第一阶段观察到的主观食欲抑制效应相应的时间且稍晚时显著减少。TFX-SR对脉搏率或血压无影响;但确实引起了一些瞳孔散大。服用TFX-SR后没有中枢神经系统刺激的证据;该药物对临界闪烁融合频率或精神运动表现均无影响。3小时后观察到主观觉醒降低,但替氟雷司在觉醒或情绪主观指标方面未引起其他显著变化。仅报告有轻微的睡眠障碍;服药后头痛的主观报告比服用安慰剂后更频繁,在12次活性药物暴露中有7次出现这种情况。服用TFX-SR后有11次出现副作用,而服用安慰剂后有5次出现副作用。

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本文引用的文献

1
Measurement of feelings using visual analogue scales.使用视觉模拟量表测量情感。
Proc R Soc Med. 1969 Oct;62(10):989-93. doi: 10.1177/003591576906201005.
2
Preliminary assessment of flutiorex, a new anorectic drug, in man.新型食欲抑制剂氟替雷司在人体中的初步评估。
Br J Clin Pharmacol. 1976 Feb;3(1):113-21. doi: 10.1111/j.1365-2125.1976.tb00578.x.