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描述口服丙氧芬对非药物滥用志愿者的主观、精神运动及生理效应。

Characterizing the subjective, psychomotor, and physiological effects of oral propoxyphene in non-drug-abusing volunteers.

作者信息

Zacny James P, Goldman Rebecca Erin

机构信息

Department of Anesthesia and Critical Care, The Pritzker School of Medicine, The University of Chicago, 5841 South Maryland Avenue, Chicago, IL 60637, USA.

出版信息

Drug Alcohol Depend. 2004 Feb 7;73(2):133-40. doi: 10.1016/j.drugalcdep.2003.09.007.

Abstract

BACKGROUND

The subjective, psychomotor, and physiological effects of a widely prescribed prescription opioid, propoxyphene, have not been studied in a population of non-drug-abusing people. The drug also has potential for abuse and it was of interest in the present study to determine if the drug had any abuse liability-related subjective effects in this population.

METHODS

Eighteen volunteers participated in a crossover, randomized, double-blind study in which they received, all p.o., placebo; 50 mg propoxyphene napsylate; 100 mg propoxyphene napsylate; 200 mg propoxyphene napsylate; 40 mg morphine sulfate; and 2 mg lorazepam. Measures were assessed before and for 300 min after drug administration.

RESULTS

Both morphine and lorazepam produced subjective effects. There were no statistically significant subjective effects obtained with any dose of propoxyphene in the group as a whole, but approximately 30-50% of the subjects did appear to experience subjective effects from the drug. Drug liking was not consistently observed in this subset. Propoxyphene, unlike lorazepam, did not impair psychomotor or cognitive performance. Both propoxyphene and morphine produced miosis.

CONCLUSIONS

There was a lack of statistically significant subjective effects of propoxyphene in the group as a whole, including a propoxyphene dose that was twice as high as the typical clinically-prescribed dose of 100 mg. However, there were some subjects who did report effects, consistent with the notion that patients differ in their sensitivity to opioid effects.

摘要

背景

一种广泛使用的处方类阿片药物——丙氧芬,其主观、精神运动及生理效应尚未在非药物滥用人群中进行研究。该药物也存在滥用的可能性,本研究旨在确定该药物在这一人群中是否具有与滥用倾向相关的主观效应。

方法

18名志愿者参与了一项交叉、随机、双盲研究,他们口服接受安慰剂、50毫克萘磺酸丙氧芬、100毫克萘磺酸丙氧芬、200毫克萘磺酸丙氧芬、40毫克硫酸吗啡及2毫克劳拉西泮。在给药前及给药后300分钟对各项指标进行评估。

结果

吗啡和劳拉西泮均产生了主观效应。总体而言,任何剂量的丙氧芬均未产生具有统计学意义的主观效应,但约30 - 50%的受试者似乎确实体验到了该药物的主观效应。在这一亚组中未始终观察到对药物的喜好。与劳拉西泮不同,丙氧芬未损害精神运动或认知表现。丙氧芬和吗啡均导致瞳孔缩小。

结论

总体而言,丙氧芬未产生具有统计学意义的主观效应,包括剂量高达典型临床处方剂量100毫克两倍的丙氧芬。然而,有一些受试者确实报告了相关效应,这与患者对阿片类药物效应的敏感性存在差异这一观点相符。

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