Buprenorphine-naloxone treatment of prescription opioid abuse: does past performance predict future results?
Buprenorphine-naloxone treatment of prescription opioid abuse: does past performance predict future results?
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DOI：
10.4088/jcp.14com09617
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发表时间：
2015-02
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通讯作者：
D. Langleben
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作者：
D. Langleben
临床精神病学杂志2015; 76（2）：195 - 197（doi：10.4088/JCP.14com09617）。©版权所有2015 Physicians Postgraduate Press，Inc.处方阿片类药物滥用是一个全国性的公共卫生问题：在美国，根据2012年全国药物使用和健康调查，450万或1.7%的1,2岁或以上的人报告目前非医疗使用止痛药，335，000人报告目前使用海洛因。自2002年以来，海洛因的使用增加了一倍多。（即吸食）处方阿片类药物吸食或吸烟（即吸入烟雾）海洛因已变得更加普遍，并受到纯度提高和成本降低的推动。5使处方阿片类药物滥用成为艾滋病毒和丙型肝炎的风险因素。6使问题进一步复杂化的是，注射处方阿片类药物的流行率可能正在增加。6然而，与海洛因相比，处方阿片类药物成瘾的文献基础有限。在本月的“关注成瘾”部分中，McDermott等人7研究了丁丙诺啡纳洛酮复方片剂治疗的第一个月和第三个月（最后一个月）戒断非法阿片类药物之间的关系。8他们发现，在前2周未戒断非法阿片类药物的参与者在试验的第9周至第12周不太可能实现戒断。除了对实践的潜在影响外，McDermott等人的文章还强调了2个一般性问题：（1）针对海洛因依赖制定的方案在多大程度上适用于处方阿片类药物？以及（2）阿片类药物使用障碍治疗反应预测的最新进展如何？McDermott及其同事报告的数据摘自36周处方阿片类药物成瘾治疗研究（POATS）的第12周至第24周。9作为次要分析，McDermott在POATS的背景下得到最好的理解，因为它已在之前的几篇论文中报道。9 - 16简而言之，POATS包括2个阶段："简短"的第1阶段，需要4周的丁丙诺啡-纳洛酮"稳定"和逐渐减少以及8周的随访。在进入第1阶段的653名参与者中，只有43名（7%）在第12周时大部分或完全禁欲。在第1阶段失败的610名患者中，360名参加了"扩展"第2阶段，持续12周，随后是4周的丁丙诺啡-纳洛酮减量和8周的随访。因此，可以描述POATS治疗的2个"初始"反应，每个阶段1个。McDermott et al发现，在2周时间点戒烟的患者中，56%在丁丙诺啡-纳洛酮治疗的最后3周内戒烟。相反，在前2周继续使用的人中，只有6%在3个月的时间点戒烟。总之，这些结果转化为94%的预测值缺乏禁欲在第9至12周，而早期禁欲的预测值低于60%。McDermott等人在其阳性和阴性预测值的分配中将"缺乏禁欲"定义为阳性试验。这有点违反直觉，因为阳性和阴性预测值通常用于描述诊断测试，在这种情况下，尿液毒理学。从临床医生的角度重新表述McDermott及其同事的发现，治疗前2周的阿片类药物阳性尿液毒理学对最后3周的阿片类药物阳性尿液毒理学具有高阳性和低阴性预测值。早期阳性尿液毒理学的预测价值与其他物质使用障碍的结果一致。然而，早期戒断的低预测值与可卡因17的类似研究形成对比，并表明需要考虑其他变量。另一个暗示未知变量的线索是POATS第一阶段的糟糕结果。与其他研究的直接比较因设计和结局指标的差异而变得复杂;然而，Sigmon等人18报告称，处方阿片类药物滥用者在2 - 4周丁丙诺啡-纳洛酮减量后改善29%-63%，而在第1阶段结束时仅7%的POATS参与者戒烟。与之前的文献一致，19在McDermott等人所涵盖的时期结束时，近一半的POATS参与者戒断或减少使用，但大多数（> 90%）在丁丙诺啡纳洛酮逐渐减量后8周内复发。9因此，McDermott等人的数据可以被认为是预测中间结局。了解这些数据对8周后患者状态的影响将是有趣的。McDermott及其同事的文章中更直接的结论是，12周的丁丙诺啡-纳洛酮治疗不足以在POATS队列中实现持续缓解。然而，目前尚不清楚McDermott等人的样本在多大程度上代表处方阿片类药物滥用人口统计学。超过40%的POATS患者报告了慢性疼痛，约30%的患者报告了海洛因或酒精滥用和抑郁症的终生患病率。所有这些因素都可能影响处方阿片类药物依赖的预后，20 - 24疼痛20，21发挥着特别大和复杂的作用。24看看这些变量如何改变McDermott等人的结果将是有趣的。参见McDermott等人的文章，第189页
J Clin Psychiatry 2015;76(2):195–197 (doi:10.4088/JCP.14com09617). © Copyright 2015 Physicians Postgraduate Press, Inc. M isuse of prescription opioids is a national public health problem: In the United States, according to the 2012 National Survey on Drug Use and Health, 4.5 million, or 1.7%, of persons aged 12 or older reported current nonmedical use of pain relievers, and 335,000 reported currently using heroin.1,2 This is an upward trend, as heroin use has more than doubled since 2002.2 Transition from ingesting or insufflating (ie, snorting) prescription opioids to snorting or smoking (ie, inhaling the fumes) heroin has become more common and is driven by the increasing purity and lower cost.3 Significant numbers of heroin users progress to intravenous use,4,5 making prescription opioid abuse a risk factor for HIV and hepatitis C.6 To further complicate the matter, the prevalence of injecting prescription opioids may be increasing.6 However, compared to heroin, prescription opioid addiction has a limited literature base. In this month’s Focus on Addiction section, McDermott et al7 examine the relationship between abstinence from illicit opioids in the first and third (last) months of treatment with buprenorphinenaloxone combination tablets.8 They found that participants not abstinent from illicit opioids in the first 2 weeks were very unlikely to achieve abstinence in weeks 9 through 12 of the trial. In addition to the potential implications for practice, the McDermott et al article highlights 2 general questions: (1) To what extent do protocols developed for heroin dependence apply to prescription opioids? and (2) What is the state of the art in the prediction of treatment response in opioid use disorders? Data reported by McDermott and colleagues are extracted from weeks 12 to 24 of the 36-week Prescription Opioid Addiction Treatment Study (POATS).9 As a secondary analysis, McDermott is best understood in the context of POATS as it has been reported in several prior papers.9–16 Briefly, POATS consisted of 2 phases: a “brief ” phase 1 that entailed a 4-week buprenorphine-naloxone “stabilization” and taper and an 8-week follow-up. Of the 653 participants who entered phase 1, only 43 (7%) were either mostly or completely abstinent at week 12. Of the 610 patients who failed phase 1, 360 enrolled in the “extended” phase 2, which lasted 12 weeks and was followed by a 4-week taper of buprenorphine-naloxone and an 8-week follow-up. Therefore, one could describe 2 “initial” responses to treatment in POATS, 1 for each phase. McDermott et al found that 56% of patients who were abstinent at the 2-week timepoint were abstinent in the last 3 weeks of buprenorphine-naloxone treatment. Conversely, only 6% of those who continued using during the first 2 weeks were abstinent at the 3-month time point. Together, these results translate to a predictive value of 94% for the lack of abstinence at weeks 9 through 12, while the predictive value of early abstinence was below 60%. McDermott et al defined “lack of abstinence” as a positive test in their assigning of positive and negative predictive values. This is somewhat counterintuitive, since positive and negative predictive values are commonly used to describe a diagnostic test, in this case, urine toxicology. To rephrase McDermott and colleagues’ findings from a clinician’s perspective, opioid-positive urine toxicology in the first 2 weeks of treatment had a high positive and low negative predictive value for opioid-positive urine toxicology in the last 3 weeks. The predictive value of the early positive urine toxicology is in line with findings in other substance use disorders. However, the low predictive value of early abstinence contrasts similar studies in cocaine17 and suggests that additional variables need to be considered. Another clue that suggests unaccounted-for variables is the poor outcome of phase 1 of the POATS. A direct comparison with other studies is complicated by differences in design and outcome measures; however, Sigmon et al18 reported between 29% and 63% improvement after a 2to 4-week buprenorphine-naloxone taper in prescription opioid abusers, while only 7% of POATS participants were abstinent at the end of phase 1. Consistent with prior literature,19 nearly half of POATS participants were abstinent or reduced their use at the end of the period covered by McDermott et al, but most (> 90%) relapsed within 8 weeks after buprenorphinenaloxone was tapered off.9 Therefore, the McDermott et al data can be thought of as predicting an intermediate outcome. It would be interesting to know what bearing these data have on the patient status 8 weeks later. A more immediate conclusion from McDermott and colleagues’ article is that 12 weeks of buprenorphine-naloxone treatment was insufficient to achieve a sustained remission in the POATS cohort. However, it is unclear to what extent the McDermott et al sample was representative of the prescription opioid abuse demographic. More than 40% of POATS patients reported chronic pain, and approximately 30% reported lifetime prevalence of heroin or alcohol abuse and depression. All of these factors are likely to influence the prognosis of prescription opioid dependence,20–24 with pain20,21 playing a particularly large and complex role.24 It would be interesting to see how these variables might have changed the McDermott et al results. See article by McDermott et al p189