Opioid therapy for chronic noncancer back pain - A randomized prospective study
Opioid therapy for chronic noncancer back pain - A randomized prospective study
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DOI：
10.1097/00007632-199812010-00014
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发表时间：
1998-12-01
期刊：
影响因子：
3
通讯作者：
Katz, NP
中科院分区：
文献类型：
--
作者：
Jamison, RN;Raymond, SA;Katz, NP
研究设计.一项随机、开放、长期、重复剂量的抗炎药和两种阿片类药物治疗36例背痛患者的比较研究。在背痛患者的随机试验中检查长期阿片类药物治疗的安全性和有效性。所有参与者都经历了为期4周的无阿片类药物的洗脱期，然后随机分配到三种治疗方案之一，为期16周：1）仅使用萘普生，2）设定剂量的羟考酮，或3）滴定剂量的羟考酮和缓释硫酸吗啡。然后，所有患者被分配到滴定剂量的阿片类药物16周，然后逐渐减少药物12周。最后，对所有参与者进行为期1个月的治疗后洗脱期监测。每周给每位患者打一次电话，报告疼痛、活动、情绪、药物、清醒时间和不良反应，并仔细监测滥用和不依从的迹象。实验阶段的每周报告显示，滴定剂量组比其他两组疼痛更少（P < 0.001），情绪困扰更少（P < 0.001）。两个阿片类药物组与仅萘普生组有显著差异。在滴定阶段，患者还报告疼痛明显减轻，情绪改善。在活动或睡眠时间，或平均治疗前和治疗后的电话采访和问卷变量之间几乎没有差异。没有不良事件发生，只有一个参与者表现出滥用行为的迹象。结果表明，阿片类药物治疗对疼痛和情绪有积极影响，但对活动和睡眠影响不大。使用阿片类药物治疗慢性背痛，没有明显的滥用风险。然而，逐渐减少的阿片类药物治疗是姑息性的，没有长期益处。
Study Design. A randomized, open, long-term, repeated-dose comparison of an anti-inflammatory drug and two opioid regimens in 36 patients with back pain.Objectives. To examine the long-term safety and efficacy of chronic opioid therapy in a randomized trial of patients with back pain.Methods. All participants underwent a 4-week washout period of no opioid medication before being randomly assigned to one of three treatment regimens for 16 weeks: 1) naproxen only, 2) set-dose oxycodone, or 3) titrated-dose oxycodone and sustained-release morphine sulfate. All patients then were assigned to a titrated dose of opioids for 16 weeks and then gradually tapered off their medication for 12 weeks. Finally, all participants were monitored for a 1-month posttreatment washout period. Each patient was called once a week for a report on pain, activity, mood, medication, hours awake, and adverse effects and as monitored carefully for signs of abuse and noncompliance.Results. Weekly reports during the experimental phase showed the titrated-dose group to have less pain (P < 0.001) and less emotional distress (P < 0.001) than the other two groups. Both opioid groups were significantly different from the naproxen-only group. During the titration phase, patients also reported significantly less pain and improved mood. Few differences were found in activity or hours asleep, or between average pretreatment and post-treatment phone-interview and questionnaire variables. No adverse events occurred, and only one participant showed signs of abuse behavior.Conclusions. The results suggest that opioid therapy has a positive effect on pain and mood but little effect on activity and sleep. Opioid therapy for chronic back pain was used without significant risk of abuse. However, tapered-off opioid treatment is palliative and without long-term benefit.