Division of Pharmacotherapies and Medical Consequences of Drug Abuse, National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.
CNS Neurosci Ther. 2012 May;18(5):414-8. doi: 10.1111/j.1755-5949.2011.00263.x. Epub 2011 Oct 18.
A multisite, double-blind, placebo-controlled trial of bupropion for methamphetamine dependence was reanalyzed using a novel, nonbinary method of evaluating success and failure. The original analysis focused on a group response endpoint (the change in percentage of participants with methamphetamine-free urines each week over the course of the trial) and no significant bupropion effect was observed in the total population of study participants. In this reanalysis, individual participants were regarded as treatment success if they achieved multiple weeks of abstinence lasting through the end of the study, and their degree of success was quantified by calculating the number of beyond-threshold weeks of success (NOBWOS). Thus, setting the threshold at 1 week of end-of-study abstinence (EOSA), treatment successes were assigned NOBWOS values ranging from 1 to 11, with 1 corresponding to 2 weeks EOSA and 11 corresponding to abstinence throughput the entire 12-week trial. Treatment failures were assigned a value of 0. Comparison of NOBWOS values revealed a significant effect of bupropion to facilitate abstinence (P= 0.0176). In the bupropion group, 20% of participants achieved 2 or more weeks EOSA, 14% achieved 6 or more weeks EOSA, and 6% were abstinent throughout the trial; this compares with 7%, 4%, and 1% in the placebo group, respectively. On the basis of the NOBWOS analysis, bupropion seems to effectively facilitate the achievement of abstinence in methamphetamine-dependent individuals.
一项针对安非他命依赖的多中心、双盲、安慰剂对照试验，采用一种新颖的非二进制方法重新分析了成功和失败。最初的分析集中在一个群体反应终点（试验过程中每周尿液中不含安非他命的参与者百分比的变化），在研究参与者的总人群中没有观察到安非他命的显著效果。在本次重新分析中，如果参与者实现了多个持续到研究结束的禁欲周，并且通过计算超过阈值的成功周数（NOBWOS）来量化他们的成功程度，那么每个参与者都被视为治疗成功。因此，将阈值设定为结束研究时的 1 周禁欲（EOSA），治疗成功的参与者被分配的 NOBWOS 值范围从 1 到 11，1 对应于 2 周 EOSA，11 对应于整个 12 周试验期间的禁欲。治疗失败的参与者被分配值 0。NOBWOS 值的比较显示安非他命促进禁欲的效果显著（P=0.0176）。在安非他命组中，20%的参与者实现了 2 周或更长时间的 EOSA，14%的参与者实现了 6 周或更长时间的 EOSA，6%的参与者在整个试验中保持禁欲状态；而在安慰剂组中，分别为 7%、4%和 1%。基于 NOBWOS 分析，安非他命似乎有效地促进了安非他命依赖者的禁欲。
