Long-term Opioid Management of Chronic Pain: Trends and Risks

描述（由申请人提供）：数百万美国人接受长期阿片类药物治疗慢性非恶性疼痛。关于这种治疗方案的决定因素和风险知之甚少。这项研究的重点是背部疼痛作为示踪条件。卫生服务研究和流行病学方法将用于了解谁接受长期阿片类药物治疗，并评估相关风险，包括阿片类药物滥用和死亡率的发生。这项研究将在两个大型非营利健康计划中进行，为超过1%的美国人口提供服务。研究目标-我们的目标是推进有关慢性疼痛患者长期阿片类药物治疗的决定因素和风险的知识。目标1-审查趋势：我们将描述1995-2006年参与健康计划的长期阿片类药物治疗的使用趋势，并确定表明临床复杂性和既往药物滥用的患者特征如何与长期阿片类药物使用趋势相关。目标2-评估阿片类药物滥用的风险：我们将评估接受长期阿片类药物治疗的人中阿片类药物滥用的风险因素。主要假设是：1）在接受长期阿片类药物治疗背痛的人群中，相对于长期使用短效阿片类药物，使用长效阿片类药物与阿片类药物滥用和误用的风险降低相关。2)既往药物滥用史将增加接受长期阿片类药物治疗背痛的患者滥用和误用阿片类药物的风险。这些假设将通过一项比较近期发病病例与对照组的病例对照研究（N=600）进行检验。目的3-评估死亡率和其他不良事件风险：我们将评估长期阿片类药物治疗是否会增加死亡率和其他不良事件风险。主要假设是：1）长期使用阿片类药物治疗背痛与死亡率增加有关。2)相对于长期使用短效阿片类药物，长期使用长效阿片类药物将增加死亡风险。3)既往药物滥用史将与接受长期阿片类药物治疗者的死亡率增加相关。我们将通过一项病例队列研究（N=1600）来评估这些假设。我们将通过研究长期阿片类药物治疗对其他不良事件的影响来扩展这些分析，这些不良事件包括：全因和阿片类药物相关住院;阿片类药物过量;以及公认的情绪障碍的发作。

DESCRIPTION (provided by applicant): Several million Americans receive long-term opioid therapy for chronic non-malignant pain. Little is known about the determinants and risks of this treatment regimen. This research focuses on back pain as a tracer condition. Health services research and epidemiologic methods will be used to understand who receives long-term opioid therapy and to assess associated risks including onset of opioid abuse and mortality. This research will be conducted in two large, non-profit health plans serving over 1% of the U.S. population. Research goals - Our goals are to advance knowledge concerning determinants and risks of long-term opioid therapy among chronic pain patients. Aim 1-Examine trends: We will describe trends in use of long-term opioid therapy in the participating health plans from 1995-2006 and determine how patient characteristics indicating clinical complexity and prior substance abuse are related to trends in long-term opioid use. Aim 2-Assess risks of opioid abuse: We will assess risk factors for opioid abuse among persons receiving long-term opioid therapy. Primary hypotheses are: 1) Among persons receiving long-term opioid therapy for back pain, use of long-acting opioids is associated with reduced risks of onset of opioid abuse and misuse relative to long-term use of short-acting opioids. 2) A prior history of drug abuse will increase risks of opioid abuse and misuse among those receiving long-term opioid therapy for back pain. These hypotheses will be tested through a case-control study comparing recent onset cases to controls (N=600). Aim 3-Assess mortality and other adverse event risks: We will assess whether mortality and other adverse event risks are increased by long-term opioid therapy. Primary hypotheses are: 1) Long-term use of opioids for back pain will be associated with increased mortality. 2) Long-term use of long-acting opioids will increase mortality risk relative to long-term use of short-acting opioids. 3) A prior history of substance abuse will be associated with increased mortality among persons receiving long-term opioid therapy. We will evaluate these hypotheses through a case-cohort study (N=1600). We will extend these analyses by studying the effects of long-term opioid therapy on other adverse events including: all-cause and opioid-related hospitalization; opioid overdose; and onset of recognized mood disorder.