Pedersen Line, Borchgrevink Petter Christian, Breivik Harald Petter, Fredheim Olav Magnus Søndenå
National Competence Centre for Complex Symptom Disorders, Trondheim, Norway Department of Circulation and Medical Imaging, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway Department of Internal Medicine, Sørlandet Hospital HF, Kristiansand, Norway Department of Pain and Complex Symptom Disorders, St. Olav's University Hospital, Trondheim, Norway Department of Pain Management and Research, Oslo University Hospital, University of Oslo, Oslo, Norway Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.
Pain. 2014 May;155(5):881-888. doi: 10.1016/j.pain.2013.12.016. Epub 2013 Dec 15.
Guidelines for opioid treatment of chronic non-malignant pain recommend long-acting over short-acting opioid formulations. The evidence for this recommendation is weak. This study is a randomized, double-blind, double-dummy, 8-week comparison of long-acting dihydrocodeine tablets (DHC-Continus) with short-acting dihydrocodeine tablets in 60 patients with chronic non-malignant pain who were referred to a multidisciplinary pain clinic. All patients used codeine-paracetamol tablets before the trial, and paracetamol was added in both groups during the trial. The primary outcome was stability in pain intensity, measured as the difference between the highest and least pain intensity reported on an 11-point numerical rating scale in a 7-day diary. The secondary outcomes were differences in quality of life, quality of sleep, depression, and episodes of breakthrough pain between the 2 formulations. Spontaneously reported adverse events were recorded. In all, 38 patients completed the trial, and 22 withdrew before the end. The reasons for withdrawal were adverse events, lack of efficacy, or both, and were similar between the groups. There were no significant differences in stability of pain intensity between groups. There were no significant differences between groups in quality of sleep, depression, health-related quality of life, or adverse events. Breakthrough pain was experienced in both groups during the trial. Long-acting dihydrocodeine was not observed to be superior for any of the outcomes in this trial. The results of this study do not support current guidelines recommending long-acting opioids.
慢性非恶性疼痛的阿片类药物治疗指南推荐使用长效而非短效阿片类制剂。这一推荐的证据并不充分。本研究是一项随机、双盲、双模拟试验，对60例转诊至多学科疼痛诊所的慢性非恶性疼痛患者，比较长效双氢可待因片（DHC-Continus）与短效双氢可待因片，为期8周。所有患者在试验前均使用可待因-对乙酰氨基酚片，试验期间两组均加用对乙酰氨基酚。主要结局是疼痛强度的稳定性，通过7天日记中11点数字评分量表上报告的最高和最低疼痛强度之差来衡量。次要结局是两种制剂在生活质量、睡眠质量、抑郁及爆发性疼痛发作方面的差异。记录自发报告的不良事件。共有38例患者完成试验，22例在试验结束前退出。退出原因是不良事件、缺乏疗效或两者皆有，两组之间相似。两组在疼痛强度稳定性方面无显著差异。两组在睡眠质量、抑郁、健康相关生活质量或不良事件方面无显著差异。试验期间两组均出现爆发性疼痛。在本试验中，未观察到长效双氢可待因在任何结局方面更具优势。本研究结果不支持目前推荐使用长效阿片类药物的指南。
