一项关于盐酸羟考酮与丙氧芬/对乙酰氨基酚联合用药治疗腰椎管狭窄症相关神经源性间歇性跛行的随机、双盲、安慰剂对照交叉试验。
A Randomized, Double-blind, Placebo-Controlled Crossover Trial of Oxymorphone Hydrochloride and Propoxyphene/Acetaminophen Combination for the Treatment of Neurogenic Claudication Associated With Lumbar Spinal Stenosis.
作者信息
Markman John D, Gewandter Jennifer S, Frazer Maria E, Murray Nicole M, Rast Shirley A, McDermott Michael P, Chowdhry Amit K, Tomkinson Emilie J, Pilcher Webster H, Walter Kevin A, Dworkin Robert H
机构信息
*Department of Neurosurgery, Translational Pain Research Program, University of Rochester, Rochester, NY †Department of Anesthesiology, University of Rochester School of Medicine & Dentistry, Rochester, NY ‡Surgery-Cancer Control Unit, University of Rochester, Rochester, NY; and Departments of §Biostatistics and Computational Biology and ¶Neurology, University of Rochester School of Medicine & Dentistry, Rochester, NY.
出版信息
Spine (Phila Pa 1976). 2015 May 15;40(10):684-91. doi: 10.1097/BRS.0000000000000837.
STUDY DESIGN
Randomized, double-blind, placebo-controlled, single-dose crossover study.
OBJECTIVE
To test the analgesic efficacy of oxymorphone hydrochloride (OH) and propoxyphene/acetaminophen (PA) for patients with neurogenic claudication associated with lumbar spinal stenosis.
SUMMARY OF BACKGROUND DATA
Although opioids are often prescribed for neurogenic claudication, no randomized controlled studies support their efficacy for this condition. Patients with neurogenic claudication are generally excluded from clinical trials or included with patients who have nonspecific chronic low back pain, yielding a heterogeneous study population with very different pathophysiologies and clinical presentations.
METHODS
Participants received a single dose of each of the 3 treatments in random order. Treatments were separated by at least 3-day washout periods. The primary outcome variable was the time to first treadmill walking-induced moderate pain (≥4 out of 10 on a Numeric Rating Scale) (Tfirst) assessed 90 minutes after treatment administration. Secondary outcome measures included patient global assessment of low back pain, Roland-Morris Disability Questionnaire, Modified Brief Pain Inventory-Short Form, Oswestry Disability Index, and Swiss Spinal Stenosis Questionnaire.
RESULTS
The study was prematurely terminated because of the removal of PA from the US market. Twenty-four patients were randomized; 21 completed all 3 treatment periods. There were no significant differences among the treatment groups with respect to the median Tfirst (OH-placebo: median [98.3% confidence limits]=-0.25 min [-6.54, 5.00]; PA-placebo: 0.02 min [-7.65, 4.90]; OH-PA: -0.27 min [-5.56, 6.66]).
CONCLUSION
This trial failed to demonstrate a benefit of OH or PA in patients experiencing neurogenic claudication. Considering the potential negative side effects of chronic opioid use, additional research is necessary to evaluate the efficacy of sustained opioid treatment specifically for neurogenic claudication.
LEVEL OF EVIDENCE
研究设计
随机、双盲、安慰剂对照、单剂量交叉研究。
目的
测试盐酸羟吗啡酮（OH）和丙氧芬/对乙酰氨基酚（PA）对腰椎管狭窄相关神经源性间歇性跛行患者的镇痛效果。
背景数据总结
尽管阿片类药物常用于治疗神经源性间歇性跛行，但尚无随机对照研究支持其对该病症的疗效。神经源性间歇性跛行患者通常被排除在临床试验之外，或与非特异性慢性下腰痛患者一起纳入研究，导致研究人群异质性，其病理生理学和临床表现差异很大。
方法
参与者按随机顺序接受三种治疗中的每一种单剂量治疗。治疗之间至少间隔3天的洗脱期。主要结局变量是治疗给药90分钟后评估的首次跑步机行走诱发中度疼痛（数字评分量表上≥4分）的时间（Tfirst）。次要结局指标包括患者对下腰痛的整体评估、罗兰-莫里斯残疾问卷、改良简短疼痛量表简表、奥斯威斯残疾指数和瑞士腰椎管狭窄问卷。
结果
由于PA从美国市场撤市，该研究提前终止。24名患者被随机分组；21名患者完成了所有3个治疗期。治疗组之间在Tfirst中位数方面无显著差异（OH-安慰剂：中位数[98.3%置信区间]=-0.25分钟[-6.54,5.00]；PA-安慰剂：0.02分钟[-7.65,4.90]；OH-PA：-0.27分钟[-5.56,6.66]）。
结论
该试验未能证明OH或PA对神经源性间歇性跛行患者有益。考虑到长期使用阿片类药物的潜在负面副作用，有必要进行更多研究以评估持续阿片类药物治疗对神经源性间歇性跛行的疗效。
证据水平
2级。
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