Trajectory of Adverse events and Analgesia with Opioids in older adults - TAANGO

老年人阿片类药物不良事件和镇痛的轨迹 - TAANGO

• 批准号: 8354635
• 负责人: RICHARD A DEYO
• 金额: $ 23.1万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-15 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8354635
• 关键词: Absence of pain sensation; Acute Pain; Adult; Adverse effects; Adverse event; Age; Agreement; Analgesics; Anti-Inflammatory Agents; Anti-inflammatory; Anxiety; Caring; Chronic; Chronic Disease; Cigarette; Cognition; Cohort Studies; Communities; Comorbidity; Consensus; Data; Dependence; Development; Dose; Dropout; Drug Addiction; Drug Tolerance; Effectiveness; Elderly; Enrollment; Ethics; Event; Exclusion; Fatigue; Fecal Impaction; Fracture; Goals; Guidelines; Hypogonadism; Impaired cognition; Incidence; Measures; Mental Depression; Mental Health; Mood Disorders; Musculoskeletal Pain; Observational Study; Opioid; Oregon; Overdose; Pain; Pain Measurement; Pain management; Palliative Care; Patients; Pattern; Pharmaceutical Preparations; Pharmacotherapy; Physical Function; Pilot Projects; Preclinical Drug Evaluation; Prevalence; Procedures; Prospective Studies; Reporting; Research; Risk; Role; Rural; Safety; Severities; Sex Functioning; Sexual Dysfunction; Sleep disturbances; Smoking; Substance abuse problem; Target Populations; Terminal Disease; Time; Urine; addiction; aged; base; cancer pain; central sensitization; chronic pain; clinically relevant; depressive symptoms; experience; falls; follow-up; neuropsychological; non-cancer pain; older patient; prescription opioid; psychosocial; response; rural area; therapy duration; time interval; urban area

DESCRIPTION (provided by applicant): Pharmacotherapy for pain in older adults often includes opioids, which are recommended in recent expert guidelines. Opioids are effective in managing acute pain and may have been underused for terminal illness and palliative care. However, the optimal approach to therapy for chronic non-cancer pain remains controversial because of sparse data on the trajectory of analgesia or adverse effects with long-term opioid use. Recent studies highlight several long-term adverse events, including overdose risk, hypogonadism, falls and fractures, and neuropsychological effects such as cognitive impairment, depression, sleep disturbance, and sexual dysfunction. For most of these, the prevalence, time course, and causal role of opioids (as opposed to chronic pain or comorbidity) remain unclear. Our ultimate goal is a prospective study of opioid prescribing patterns, analgesic effects, and adverse effects in rural Oregon, enrolling patients with chronic pain prior to opioid initiation. Before embarking on such a cohort study, we propose a pilot to establish the feasibility of research procedures, estimate the incidence of long-term opioid initiation, and estimate the incidence of selected drug effects.The pilot study will be conducted in the Oregon Rural Practice Research Network. The target population is adults over age 55 with chronic musculoskeletal pain. The Specific Aims are: (1) To demonstrate that we can enroll adequate numbers of target patients from rural practices and obtain high rates of follow up on study measures; (2) To estimate rates of initiating opioid therapy in our target population, and tentative predictors of long term use (such as pain severity, comorbidity, prior opioid therapy, use of other controlled substances, smoking, and mood disorders); and (3) To determine the trajectory of analgesia and neuropsychological adverse effects (depression, applied cognition, fatigue, sleep disturbance, sexual dysfunction) beginning prior to opioid therapy and during the year following initiation of long-term opioid therapy. We hypothesize that there is initial analgesc benefit that wanes as drug tolerance occurs, but resumes with dose increases. We also hypothesize that opioids will be associated with new or exacerbated neuropsychological events that increase with duration of therapy. PUBLIC HEALTH RELEVANCE: Chronic pain and painkiller use are common in older adults. Differences between young and old regarding physical and psychosocial responses to pain and opioid therapy require specific study in the elderly. Optimal care remains controversial, as efficacy of opioids for chonic pain remains uncertain, and side effects are increasingly recognized. New evidence will help doctors and patients to make better treatment choices.

描述（由申请人提供）：老年人疼痛的药物治疗通常包括阿片类药物，这是最近的专家指南中推荐的。阿片类药物可有效治疗急性疼痛，但可能未充分用于晚期疾病和姑息治疗。然而，治疗慢性非癌症疼痛的最佳方法仍然存在争议，因为长期使用阿片类药物的镇痛或不良反应的轨迹数据稀少。最近的研究强调了几种长期不良事件，包括过量风险、性腺功能减退、福尔斯和骨折，以及神经心理学影响，如认知障碍、抑郁、睡眠障碍和性功能障碍。对于其中大多数，阿片类药物（相对于慢性疼痛或合并症）的患病率，时间进程和因果关系仍不清楚。我们的最终目标是在俄勒冈州农村进行一项关于阿片类药物处方模式、镇痛作用和不良反应的前瞻性研究，招募阿片类药物治疗前患有慢性疼痛的患者。在进行这样的队列研究之前，我们建议进行一项试点研究，以确定研究程序的可行性，估计长期阿片类药物启动的发生率，并估计选定药物作用的发生率。试点研究将在俄勒冈州农村实践研究网络进行。目标人群是55岁以上患有慢性肌肉骨骼疼痛的成年人。具体目标是：（1）证明我们可以从农村实践中招募足够数量的目标患者，并获得高的研究措施随访率;（2）估计我们目标人群中开始阿片类药物治疗的比例，以及长期使用的初步预测因素（如疼痛严重程度、合并症、既往阿片类药物治疗、使用其他受控物质、吸烟和情绪障碍）;和（3）确定阿片类药物治疗前和开始长期阿片类药物治疗后一年内镇痛和神经心理学不良反应（抑郁、应用认知、疲劳、睡眠障碍、性功能障碍）的轨迹。我们假设最初的镇痛效果随着药物耐受性的出现而减弱，但随着剂量的增加而恢复。我们还假设阿片类药物将与新的或加重的神经心理事件相关，这些事件随着治疗时间的延长而增加。 公共卫生相关性：慢性疼痛和止痛药的使用在老年人中很常见。年轻人和老年人对疼痛和阿片类药物治疗的生理和心理反应的差异需要在老年人中进行专门研究。最佳护理仍然存在争议，因为阿片类药物对慢性疼痛的疗效仍然不确定，并且副作用越来越多地被认识到。新的证据将帮助医生和患者做出更好的治疗选择。