Jamison R N, Raymond S A, Slawsby E A, Nedeljkovic S S, Katz N P
Department of Anesthesia, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Spine (Phila Pa 1976). 1998 Dec 1;23(23):2591-600. doi: 10.1097/00007632-199812010-00014.
A randomized, open, long-term, repeated-dose comparison of an anti-inflammatory drug and two opioid regimens in 36 patients with back pain.
To examine the long-term safety and efficacy of chronic opioid therapy in a randomized trial of patients with back pain.
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 was monitored carefully for signs of abuse and noncompliance.
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 posttreatment phone-interview and questionnaire variables. No adverse events occurred, and only one participant showed signs of abuse behavior.
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.
一项针对36名背痛患者的抗炎药物与两种阿片类药物治疗方案的随机、开放、长期、重复剂量比较研究。
在一项针对背痛患者的随机试验中，研究慢性阿片类药物治疗的长期安全性和有效性。
所有参与者在接受为期4周的无阿片类药物洗脱期后，被随机分配至三种治疗方案之一，为期16周：1）仅服用萘普生；2）固定剂量的羟考酮；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至滴定剂量的阿片类药物治疗16周，随后在12周内逐渐减少用药剂量。最后，对所有参与者进行为期1个月的治疗后洗脱期监测。每周给每位患者打电话一次，了解其疼痛、活动、情绪、用药、清醒时长及不良反应情况，并密切监测其滥用药物和不依从的迹象。
实验阶段的每周报告显示，滴定剂量组的疼痛程度（P < 0.001）和情绪困扰程度（P < 0.001）均低于其他两组。两个阿片类药物组与仅服用萘普生的组均存在显著差异。在滴定阶段，患者报告的疼痛也显著减轻，情绪有所改善。在活动或睡眠时间方面，以及治疗前和治疗后平均电话访谈及问卷变量之间，几乎没有发现差异。未发生不良事件，只有一名参与者出现滥用药物行为的迹象。
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。慢性背痛的阿片类药物治疗未出现显著的滥用风险。然而，逐渐减少阿片类药物治疗只是姑息性的，并无长期益处。
