Richards J Scott, Bombardier Charles H, Wilson Catherine S, Chiodo Anthony E, Brooks Larry, Tate Denise G, Temkin Nancy R, Barber Jason K, Heinemann Allen W, McCullumsmith Cheryl, Fann Jesse R
Department of Physical Medicine and Rehabilitation, University of Alabama at Birmingham, Birmingham, AL.
Department of Rehabilitation Medicine, University of Washington, Seattle, WA.
Arch Phys Med Rehabil. 2015 Apr;96(4):680-9. doi: 10.1016/j.apmr.2014.11.024. Epub 2014 Dec 17.
To (1) determine the efficacy of venlafaxine XR for the treatment of pain (secondary aim) in individuals with spinal cord injury (SCI) enrolled in a randomized controlled trial (RCT) on the efficacy of venlafaxine XR for major depressive disorder (MDD) (primary aim); and (2) test the hypothesis that venlafaxine XR would be effective for both neuropathic and nociceptive pain.
Multisite, double-blind, randomized (1:1) controlled trial with subjects block randomized and stratified by site, lifetime history of substance abuse, and prior history of MDD.
Six Departments of Physical Medicine and Rehabilitation in university-based medical schools.
Individuals (N=123) with SCI and major depression between 18 and 64 years of age, at least 1 month post-SCI who also reported pain.
Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule.
A 0-to-10 numeric rating scale for pain, pain interference items of the Brief Pain Inventory; 30% and 50% responders.
The effect of venlafaxine XR on neuropathic pain was similar to that of placebo. However venlafaxine XR resulted in statistically significant and clinically meaningful reductions in nociceptive pain site intensity and interference even after controlling for anxiety, depression, and multiple pain sites within the same individual. For those who achieved a minimally effective dose of venlafaxine XR, some additional evidence of effectiveness was noted for those with mixed (both neuropathic and nociceptive) pain sites.
Venlafaxine XR could complement current medications and procedures for treating pain after SCI and MDD that has nociceptive features. Its usefulness for treating central neuropathic pain is likely to be limited. Research is needed to replicate these findings and determine whether the antinociceptive effect of venlafaxine XR generalizes to persons with SCI pain without MDD.
（1）在一项关于文拉法辛缓释片治疗重度抑郁症（MDD）疗效的随机对照试验（RCT）中，确定文拉法辛缓释片对脊髓损伤（SCI）患者疼痛（次要目标）的治疗效果（主要目标）；（2）检验文拉法辛缓释片对神经性疼痛和伤害性疼痛均有效的假设。
多中心、双盲、随机（1:1）对照试验，受试者按部位、药物滥用终生史和MDD既往史进行区组随机化和分层。
大学医学院的六个物理医学与康复科。
123名年龄在18至64岁之间、SCI后至少1个月且伴有重度抑郁症且报告有疼痛的个体。
采用灵活滴定方案，对文拉法辛缓释片与安慰剂进行为期12周的试验。
0至10的疼痛数字评分量表、简明疼痛问卷中的疼痛干扰项目；30%和50%的有效应答者。
文拉法辛缓释片对神经性疼痛的效果与安慰剂相似。然而，即使在控制了焦虑、抑郁和同一个体内的多个疼痛部位后，文拉法辛缓释片在伤害性疼痛部位强度和干扰方面仍导致了具有统计学意义和临床意义的降低。对于达到文拉法辛缓释片最低有效剂量的患者，在有混合性（神经性和伤害性）疼痛部位的患者中发现了一些额外的有效性证据。
文拉法辛缓释片可补充目前用于治疗SCI和具有伤害性特征的MDD后疼痛的药物和程序。其治疗中枢神经性疼痛的效用可能有限。需要进行研究以重复这些发现，并确定文拉法辛缓释片的抗伤害感受作用是否适用于没有MDD的SCI疼痛患者。
