Veteran's Affairs Greater Los Angeles Health Care System, Los Angeles, California 90073, USA.
J Pain. 2011 Feb;12(2):288-96. doi: 10.1016/j.jpain.2010.09.003. Epub 2010 Nov 26.
The use of opioid medications for treating chronic noncancer pain is growing; however, there is a lack of good evidence regarding their long-term effectiveness, association with substance abuse, and proper prescribing guidelines. The current study directly compares for the first time in a randomized trial the effectiveness of a conservative, hold the line (Stable Dose) prescribing strategy for opioid medications with a more liberal dose escalation (Escalating Dose) approach. This 2-arm, parallel, randomized pragmatic clinical trial followed 135 patients referred to a specialty pain clinic at a Veterans Affairs Hospital for 12 months (94% male and 74% with musculoskeletal pain). Primary outcomes included monthly or quarterly evaluations of pain severity, pain relief from medications, pain-related functional disability, and opioid misuse behaviors. All subjects received identical pain treatment except for the application of treatment group specific strategies for opioid prescriptions. No group differences were found for primary outcomes of usual pain or functional disability although the Escalating Dose group did show a small but significantly larger increase in self-rated pain relief from medications. About 27% of patients were discharged over the course of the study due to opioid misuse/noncompliance, but there were no group differences in rate of opioid misuse.
The results of this study demonstrate that even in carefully selected patients there is a significant risk of problematic opioid misuse. Although in general there were no statistically significant differences in the primary outcomes between groups, the escalating dose strategy did lead to small improvements in self-reported acute relief from medications without an increase in opioid misuse, compared to the stable dose strategy.
阿片类药物用于治疗慢性非癌性疼痛的使用正在增加；然而，关于其长期疗效、与物质滥用的关联以及适当的处方指南，证据并不充分。本研究首次在一项随机试验中直接比较了保守的、坚持原剂量（稳定剂量）阿片类药物处方策略与更宽松的剂量递增（递增剂量）方法的有效性。这项 2 臂、平行、随机实用临床试验对 135 名在退伍军人事务医院的专科疼痛诊所就诊的患者进行了为期 12 个月的随访（94%为男性，74%为肌肉骨骼疼痛）。主要结局包括每月或每季度评估疼痛严重程度、药物缓解疼痛、与疼痛相关的功能障碍和阿片类药物滥用行为。所有患者接受相同的疼痛治疗，除了应用特定于治疗组的阿片类药物处方策略。虽然递增剂量组在自我报告的药物缓解疼痛方面确实有较小但显著更大的增加，但在常规疼痛或功能障碍的主要结局方面，两组之间没有差异。在研究过程中，约 27%的患者因阿片类药物滥用/不遵守规定而出院，但两组在阿片类药物滥用率方面没有差异。
本研究结果表明，即使在精心挑选的患者中，也存在阿片类药物滥用的严重风险。尽管总体而言，两组之间在主要结局方面没有统计学上的显著差异，但与稳定剂量策略相比，递增剂量策略确实导致自我报告的药物急性缓解略有改善，而没有增加阿片类药物滥用。
