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药物成瘾潜力研究中药物喜好程度的测量:单极与双极视觉模拟量表的比较

Measurement of Drug Liking in Abuse Potential Studies: A Comparison of Unipolar and Bipolar Visual Analog Scales.

作者信息

Setnik Beatrice, Roland Carl L, Pixton Glenn, Webster Lynn

机构信息

Pfizer Inc, Durham, NC, USA.

PRA Health Sciences, Salt Lake City, UT, USA.

出版信息

J Clin Pharmacol. 2017 Feb;57(2):266-274. doi: 10.1002/jcph.801. Epub 2016 Aug 23.

DOI:10.1002/jcph.801
PMID:27444046
Abstract

Abuse liability studies usually measure drug liking using 100-mm visual analog scales (VAS), presented as unipolar (liking measured on entire scale) or bipolar (liking and disliking measured with a neutral midpoint). These 2 types of VAS were compared using drug liking ratings from a randomized double-blind crossover study of immediate-release and controlled-release oxycodone in 2 cohorts of nondependent recreational opioid users. Cohort 1 (n = 19) received intact oxycodone 40 mg, intact OxyContin 40 and 80 mg, crushed OxyContin 40 mg, and placebo, while cohort 2 (n = 16) received intact oxycodone 20, 40, and 80 mg and placebo. In general, bipolar and unipolar ratings were positively correlated (r = 0.72) for all values (n = 2,477). E for both scales generally had higher correlation than individual responses for active drug or placebo. The correlation for individual scores after placebo treatment for the 2 scales was poor in both cohorts (r = -0.11, cohort 1 and r = 0.17, cohort 2). Both scales performed similarly within the context of the study, but bipolar scales can also assess disliking, which may be a consideration depending on anticipated drug effects. Appropriate participant training on the use of these scales is also necessary to reduce variability.

摘要

滥用可能性研究通常使用100毫米视觉模拟量表(VAS)来衡量药物喜好程度,该量表呈现为单极(在整个量表上测量喜好程度)或双极(以中性中点测量喜好和不喜欢程度)。在两项非依赖型娱乐性阿片类药物使用者队列中,通过速释和控释羟考酮的随机双盲交叉研究中的药物喜好评分,对这两种类型的VAS进行了比较。队列1(n = 19)接受完整的40毫克羟考酮、完整的40毫克和80毫克奥施康定、碾碎的40毫克奥施康定以及安慰剂,而队列2(n = 16)接受20毫克、40毫克和80毫克完整的羟考酮以及安慰剂。总体而言,对于所有数值(n = 2477),双极和单极评分呈正相关(r = 0.72)。两种量表的E值通常比活性药物或安慰剂的个体反应具有更高的相关性。在两个队列中,安慰剂治疗后两种量表的个体得分相关性均较差(队列1中r = -0.11,队列2中r = 0.17)。在该研究背景下,两种量表表现相似,但双极量表还可以评估不喜欢程度,这可能是一个需要考虑的因素,具体取决于预期的药物效果。为了减少变异性,对参与者进行这些量表使用的适当培训也是必要的。

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