Arfken Cynthia L, Schuster Charles R, Johanson Chris-Ellyn
Department of Psychiatry and Behavioral Neurosciences, Addiction Research Institute, Wayne State University, 2761 E Jefferson, Detroit, MI 48207, USA.
Drug Alcohol Depend. 2003 Mar 1;69(2):169-73. doi: 10.1016/s0376-8716(02)00311-3.
The abuse liability of medications is a growing concern as the number of newly approved psychoactive medications increases. Postmarketing surveillance can assist in determining abuse liability, but strategies are not well-defined for medications believed to be at low abuse risk. Using a newly approved medication (sibutramine--an anorectic drug), a novel approach to postmarketing abuse surveillance was introduced. A one-page anonymous questionnaire covering sibutramine, a scheduled anorectic drug (phentermine), and a fabricated name was added to the intake process of 58 treatment programs. From the 8780 completed questionnaires, 8.8% had heard of sibutramine and phentermine. For continued use to get high (a proxy for abuse), the rate for sibutramine was lower than for phentermine (0.6 vs. 2.2%, McNemar's chi(2) = 110.45, P < 0.001) but was higher than for the fabricated name (0.6 vs. 0.3%, McNemar's chi(2) = 11.86, P < 0.001). These results suggest the risk of abuse associated with sibutramine was lower than that associated with a known abused drug, one that itself is considered low risk despite decades of population exposure. The relatively high rate of hearing of sibutramine may be due to the direct-to-consumer advertisement. This approach is only one indicator in a surveillance framework but appears promising and validates findings from laboratory-based abuse liability studies that also indicate low abuse liability for sibutramine.
随着新批准的精神活性药物数量增加，药物的滥用倾向问题日益受到关注。上市后监测有助于确定药物的滥用倾向，但对于被认为滥用风险较低的药物，相关策略尚不明确。利用一种新批准的药物（西布曲明——一种食欲抑制剂），引入了一种新的上市后滥用监测方法。在58个治疗项目的接诊过程中加入了一份单页匿名问卷，内容涵盖西布曲明、一种列入管制的食欲抑制剂（苯丁胺）以及一个虚构的名称。在8780份已完成的问卷中，8.8%的人听说过西布曲明和苯丁胺。就持续使用以寻求快感（滥用的一种替代指标）而言，西布曲明的比例低于苯丁胺（0.6%对2.2%，McNemar卡方检验χ² = 110.45，P < 0.001），但高于虚构名称（0.6%对0.3%，McNemar卡方检验χ² = 11.86，P < 0.001）。这些结果表明，与西布曲明相关的滥用风险低于与一种已知滥用药物相关的风险，尽管该已知滥用药物经过数十年的人群接触，但本身被认为风险较低。西布曲明相对较高的知晓率可能归因于面向消费者的广告宣传。这种方法只是监测框架中的一个指标，但看起来很有前景，并验证了基于实验室的滥用倾向研究结果，这些结果也表明西布曲明的滥用倾向较低。
