Vorsanger Gary J, Farrell Jean, Xiang Jim, Chow Wing, Moskovitz Bruce L, Rosenthal Norman R
Janssen Scientific Affairs, LLC, Raritan, NJ, USA.
Pain Manag. 2013 Mar;3(2):109-18. doi: 10.2217/pmt.13.5.
SUMMARY
Tapentadol is a centrally acting analgesic that combines µ-opioid receptor agonism with norepinephrine reuptake inhibition. This study evaluated the efficacy and safety of tapentadol immediate-release (IR), oxycodone IR or placebo in subjects with acute pain from vertebral compression fracture (VCF) associated with osteoporosis.
PATIENTS & METHODS: Study patients were adults with new onset of pain or acute exacerbation of previous pain from VCF associated with osteoporosis, radiographic confirmation of VCF and back pain intensity of 5 or greater on an 11-point scale from 0 (no pain) to 10 (pain as bad as you can imagine). Patients were randomized to treatment with tapentadol IR (50 mg, then 50 or 75 mg), oxycodone IR (5 mg, then 5 or 10 mg) or placebo every 4-6 h as needed for pain, for up to 10 days. Twice daily, subjects recorded pain intensity on the 11-point scale (numeric rating scale), pain relief on a 5-point scale from 0 (none) to 4 (complete), sleep assessments (morning assessment only) and any episodes of vomiting (evening assessment only).
The study was designed to include 625 subjects, but was stopped after 14 months due to slow enrollment (44 tapentadol IR, 43 oxycodone IR and 21 placebo subjects) and had insufficient statistical power for comparative efficacy analyses. Discontinuation rates in the tapentadol IR, oxycodone IR and placebo groups were 18.2, 27.9 and 9.5%, respectively, often due to adverse events (4.5, 18.6 and 4.8%, respectively). Treatment-emergent adverse-event rates were 63.6, 81.4 and 38.1%, respectively.
In this prematurely terminated study in adults with painful VCF, trends suggested that tapentadol IR was tolerated better than oxycodone IR.
总结
曲马多是一种中枢性镇痛药，它结合了μ-阿片受体激动作用和去甲肾上腺素再摄取抑制作用。本研究评估了速释曲马多、速释羟考酮或安慰剂在患有与骨质疏松症相关的椎体压缩骨折（VCF）急性疼痛患者中的疗效和安全性。
研究患者为患有与骨质疏松症相关的VCF新发疼痛或既往疼痛急性加重的成年人，经影像学证实为VCF，且背痛强度在0（无疼痛）至10（想象中最严重的疼痛）的11分制量表上为5分或更高。患者被随机分配接受速释曲马多（50mg，然后50或75mg）、速释羟考酮（5mg，然后5或10mg）或安慰剂治疗，根据疼痛情况每4 - 6小时按需给药，最长给药10天。受试者每天记录两次11分制量表上的疼痛强度（数字评分量表）、0（无缓解）至4（完全缓解）的5分制量表上的疼痛缓解情况、睡眠评估（仅早晨评估）以及任何呕吐发作情况（仅晚上评估）。
该研究计划纳入625名受试者，但由于入组缓慢（44名曲马多速释组、43名羟考酮速释组和21名安慰剂组受试者），在14个月后停止，且没有足够的统计效力进行比较疗效分析。曲马多速释组、羟考酮速释组和安慰剂组的停药率分别为18.2%、27.9%和9.5%，通常是由于不良事件（分别为4.5%、18.6%和4.8%）。治疗中出现的不良事件发生率分别为63.6%、81.4%和38.1%。
在这项针对患有疼痛性VCF的成年人的提前终止的研究中趋势表明，速释曲马多比速释羟考酮耐受性更好。
