Setnik Beatrice, Roland Carl L, Pixton Glenn, Webster Lynn
Pfizer Inc, Durham, NC, USA.
PRA Health Sciences, Salt Lake City, UT, USA.
J Clin Pharmacol. 2017 Feb;57(2):266-274. doi: 10.1002/jcph.801. Epub 2016 Aug 23.
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.
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。