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口服吗啡治疗慢性非癌性疼痛的随机试验。

Randomised trial of oral morphine for chronic non-cancer pain.

作者信息

Moulin D E, Iezzi A, Amireh R, Sharpe W K, Boyd D, Merskey H

机构信息

Department of Clinical Neurological Sciences, University of Western Ontario, London, Canada.

出版信息

Lancet. 1996 Jan 20;347(8995):143-7. doi: 10.1016/s0140-6736(96)90339-6.

Abstract

BACKGROUND

The use of opioid analgesics for chronic non-cancer pain is controversial. Some surveys report good pain relief and improvement in performance while others suggest a poor outcome with a propensity to psychological dependence or addiction.

METHODS

We undertook a randomised double-blind crossover study to test the hypothesis that oral morphine relieves pain and improves the quality of life in patients with chronic regional pain of soft tissue or musculoskeletal origin who have not responded to codeine, anti-inflammatory agents, and antidepressants. Morphine was administered as a sustained-release preparation in doses up to 60 mg twice daily and compared with benztropine (active placebo) in doses up to 1 mg twice daily over three-week titration, six-week evaluation, and two-week washout phases. Pain intensity, pain relief, and drug liking were rated weekly and psychological features, functional status, and cognition were assessed at baseline and at the end of each evaluation phase.

FINDINGS

After dose titration in the 46 patients who completed the study, the mean daily doses of drugs were morphine 83.5 mg and benztropine 1.7 mg. On visual analogue scales, the morphine group showed a reduction in pain intensity relative to placebo in period I (p = 0.01) and this group also fared better in a crossover analysis of the sum of pain intensity differences from baseline (p = 0.02). No other significant differences were detected.

INTERPRETATION

In patients with treatment-resistant chronic regional pain of soft-tissue or musculoskeletal origin, nine weeks of oral morphine in doses up to 120 mg daily may confer analgesic benefit with a low risk of addiction but is unlikely to yield psychological or functional improvement.

摘要

背景

阿片类镇痛药用于慢性非癌性疼痛存在争议。一些调查显示疼痛缓解良好且功能有所改善,而另一些调查则表明效果不佳,且有产生心理依赖或成瘾的倾向。

方法

我们进行了一项随机双盲交叉研究,以检验以下假设:对于软组织或肌肉骨骼源性慢性局部疼痛且对可待因、抗炎药和抗抑郁药无反应的患者,口服吗啡可缓解疼痛并改善生活质量。吗啡以缓释制剂给药,剂量高达每日两次60毫克,并在为期三周的滴定期、六周的评估期和两周的洗脱期内,与剂量高达每日两次1毫克的苯海索(活性安慰剂)进行比较。每周对疼痛强度、疼痛缓解情况和药物喜好程度进行评分,并在基线以及每个评估阶段结束时评估心理特征、功能状态和认知情况。

研究结果

在完成研究的46名患者中进行剂量滴定后,药物的平均日剂量分别为吗啡83.5毫克和苯海索1.7毫克。在视觉模拟量表上,吗啡组在第一阶段相对于安慰剂显示疼痛强度有所降低(p = 0.01),并且在从基线开始的疼痛强度差异总和的交叉分析中,该组表现也更好(p = 0.02)。未检测到其他显著差异。

解读

对于软组织或肌肉骨骼源性难治性慢性局部疼痛患者,每日口服剂量高达120毫克的吗啡持续九周可能具有镇痛效果且成瘾风险较低,但不太可能带来心理或功能改善。

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