慢性非癌性疼痛患者长期阿片类药物治疗的逐渐减量：一项随机临床试验。

Tapering off long-term opioid therapy in chronic non-cancer pain patients: A randomized clinical trial.

作者信息

Kurita G P, Højsted J, Sjøgren P

机构信息

Palliative Research Group, Department of Oncology, Rigshospitalet - Copenhagen University Hospital, Denmark.

Multidisciplinary Pain Centre, Department of Neuroanaesthesiology, Rigshospitalet - Copenhagen University Hospital, Denmark.

出版信息

Eur J Pain. 2018 May 13. doi: 10.1002/ejp.1241.

DOI:10.1002/ejp.1241

PMID:29754428

Abstract

BACKGROUND

The indications for initiating long-term opioid treatment (L-TOT) for chronic non-cancer pain (CNCP) are often unclear and associated with problematic use. This study aimed at evaluating the efficacy of stabilizing opioid therapy followed by a sequential opioid tapering off program in CNCP patients.

METHODS

A randomized clinical trial with a medications stabilization period (Phase 1) was followed by an opioid tapering off program (Phase 2). In Phase 2, patients were randomized to Control Group (stable treatment) or Taper off Group (sequential opioid dose reduction) and assessed at baseline, after stabilization and up to 6 months. Primary outcomes: measures of cognitive function; secondary outcomes: pain, sleep, rest, quality of life, depression, anxiety, opioid misuse and opioid withdrawal symptoms.

RESULTS

In all, 274 patients were screened; 75 were included, out of which 40 dropped out before Phase 2. Those who succeeded Phase 1 (n = 35) had weak/moderate improvements of psychomotor function (p = 0.020), sleeping hours (p = 0.031), opioid withdrawal symptoms (p = 0.019), measures of quality of life (p ≤ 0.043) and opioid misuse scores (p = 0.003). In Phase 2, patients in Taper off Group (n = 15) experienced stable pain intensity and felt significantly more rested at third assessment than the Control Group (n = 20).

CONCLUSIONS

The opioid tapering off program was not successful due to the vast number of dropouts. Phase 1 was associated with weak to moderate improvements on psychomotor function, sleeping, opioid withdrawal symptoms, quality of life and reduced risk of opioid misuse. In the intervention group of Phase 2, pain intensity was stable and patients felt more rested.

SIGNIFICANCE

This trial showed that sequential tapering off L-TOT in CNCP patients may be an unfeasible approach. However, improvements after opioid treatment stabilization were achieved and stable pain intensity in those tapered off may encourage the development of more refined programs.

摘要

背景

对于慢性非癌性疼痛（CNCP）启动长期阿片类药物治疗（L-TOT）的指征通常不明确，且与药物滥用问题相关。本研究旨在评估在CNCP患者中先稳定阿片类药物治疗，然后进行序贯阿片类药物减量方案的疗效。

方法

进行一项随机临床试验，先有一个药物稳定期（第1阶段），随后是阿片类药物减量方案（第2阶段）。在第2阶段，患者被随机分为对照组（稳定治疗）或减量组（序贯减少阿片类药物剂量），并在基线、稳定期后及长达6个月时进行评估。主要结局：认知功能指标；次要结局：疼痛、睡眠、休息、生活质量、抑郁、焦虑、阿片类药物滥用及阿片类药物戒断症状。

结果

共筛查了274例患者；纳入75例，其中40例在第2阶段前退出。成功完成第1阶段的患者（n = 35）在精神运动功能（p = 0.020）、睡眠时间（p = 0.031）、阿片类药物戒断症状（p = 0.019）、生活质量指标（p≤0.043）和阿片类药物滥用评分（p = 0.003）方面有轻度至中度改善。在第2阶段，减量组（n = 15）的患者疼痛强度稳定，且在第三次评估时比对照组（n = 20）感觉休息得明显更好。