Transdermal buprenorphine plus oral paracetamol vs an oral codeine-paracetamol combination for osteoarthritis of hip and/or knee: a randomised trial
Transdermal buprenorphine plus oral paracetamol vs an oral codeine-paracetamol combination for osteoarthritis of hip and/or knee: a randomised trial
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DOI：
10.1016/j.joca.2011.03.011
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发表时间：
2011-08-01
影响因子：
7
通讯作者：
Schofield, J. P.
中科院分区：
文献类型：
--
作者：
Conaghan, P. G.;O'Brien, C. M.;Schofield, J. P.
目的：小剂量经皮阿片类药物为骨关节炎（OA）提供了一种新的治疗选择。本研究比较了丁丙诺啡贴片加口服扑热息痛与口服可待因-扑热息痛联合片（co-codamol）对老年OA患者的症状缓解效果。方法：220例OA髋部和/或膝关节疼痛患者（年龄60岁）随机分组，接受7天丁丙诺啡贴片加口服扑热息痛（5-25 μ g/h丁丙诺啡贴片加口服扑热息痛1000 mg，每日4次）治疗；N = 110)或co-codamol片（2片8/500,2片30/500 mg，每日一次；N = 110）。他们进入了长达10周的滴定期，在此期间，他们的研究药物剂量被调整，直到他们达到最佳的疼痛控制。达到最佳疼痛控制的患者进入为期12周的评估期。主要终点是使用box scale-11 （BS-11）疼痛量表记录的平均每日疼痛评分。结果：两种治疗方法均显著降低了患者疼痛评分。每个方案（PP）人群的估计治疗差异[95%置信区间（Cl）]为-0.02（-0.64,0.60）。整个分析人群的结果是相似的。服用7天丁丙诺啡贴片加口服扑热息痛的患者比服用co-codamol片的患者需要更少的逃避药物（布洛芬）（P=0.002: PP人群）。在7天丁丙诺啡贴片加口服扑热息痛组中，不到10%的患者在研究结束时接受了最高剂量水平，而co-codamol组为34%。两组患者的停药率均较高。不良事件发生率（ae）在两组间具有可比性（7天丁丙诺啡贴片加口服扑热息痛组为86.4%，复方可达莫组为81.7%）。7天丁丙诺啡贴片加口服扑热息痛组3例（2.7%）发生严重不良反应，co-codamol组1例（0.9%）发生严重不良反应。结论：7天丁丙诺啡贴片加口服扑热息痛对老年OA髋/膝关节疼痛的镇痛效果不逊色于co-codamol片。Clintrials.gov号码：NO-00324038。(C) 2011国际骨关节炎研究学会。Elsevier Ltd.出版。版权所有，
Objective: Low-dose transdermal opioids offer a new therapeutic option for osteoarthritis (OA). This study compared symptom relief obtained with buprenorphine patches plus oral paracetamol with that obtained with an oral codeine-paracetamol combination tablet (co-codamol) in older adults with OA.Method: Two hundred and twenty people (aged >= 60 years) with OA hip and/or knee pain were randomised to treatment with 7-day buprenorphine patches plus oral paracetamol (5-25 mu g/h buprenorphine patches plus 1000 mg oral paracetamol q.i.d. (4 times daily); n = 110) or co-codamol tablets (two 8/500 two 30/500 mg tablets q.i.d.; n = 110). They entered a titration period of up to 10 weeks, during which their dose of study medication was adjusted until they reached optimum pain control. Patients who achieved optimum pain control entered a 12-week assessment period. The primary outcome was average daily pain scores recorded using the box scale-11 (BS-11) pain scale.Results: Both treatments significantly reduced patient pain scores. The estimated treatment difference [95% confidence interval (Cl)] was -0.02 (-0.64, 0.60) for the per protocol (PP) population. The results were similar for the full analysis population. Patients receiving 7-day buprenorphine patches plus oral paracetamol needed significantly less escape medication (ibuprofen) than those receiving co-codamol tablets (P=0.002: PP population). Less than 10% of patients in the 7-day buprenorphine patches plus oral paracetamol group were receiving the highest dose level at the end of the study, compared with 34% in the co-codamol group. Withdrawal rates were high in both groups. The incidence of adverse events (AEs) was comparable between the groups (86.4% of patients in the 7-day buprenorphine patches plus oral paracetamol group; 81.7% in the co-codamol group). Six serious AEs were reported in three patients (2.7%) in the 7-day buprenorphine patches plus oral paracetamol group and one (0.9%) in the co-codamol group.Conclusions: 7-day buprenorphine patches plus oral paracetamol were non-inferior to co-codamol tablets with respect to analgesic efficacy in older adults with OA pain in the hip/knee. Clintrials.gov number: NO-00324038. (C) 2011 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved,