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Pregabalin and Radicular Pain Study (PARPS) for Cervical Spondylosis in a Multiracial Asian Population

机译:普瑞巴林和根源性疼痛研究(PARPS)用于亚洲多种族人群的颈椎病

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Background: Pain from cervical spondylosis (CS) may result from degenerative spinal canal stenosis (cervical spondylotic myelopathy (CSM)) or lateral recesses compromise, leading to nerve root compression (cervical spondylotic radiculopathy (CSR)). Pregabalin was shown to be effective in randomized, placebo-controlled trials for post-herpetic neuralgia and diabetic neuropathy. We evaluate its efficacy in CS with underlying CSR or CSM in a prospective study comprising Asian patients for the first time. Methods: Patients with CS and CSR or CSM (clinical, MRI, or electrophysiological evidence) presenting with neuropathic pain were recruited. We excluded patients with diabetes, underlying neurological disease or who were previously on antiepileptics. Pregabalin 75 mg bd was administered for 4 weeks, after which dosage was increased to 150 mg bd for another 4 weeks if the visual analog scale (VAS) was not reduced by 50%. In addition, we monitored the short form McGill pain questionnaire (SFMPQ) at baseline, 4 weeks and 8 weeks. Mood changes were monitored using the hospital anxiety and depression score (HADS) with an identical timeline. Results: We recruited 50 patients, of which 23 completed the trial. Of the 27 who withdrew, 12 (44%) were for somnolence. Thirteen patients’ (54%) dosages remained at 75 mg and 11 patients’ (46%) dosages were escalated to 150 mg bd. There were significantly reducing trends from baseline for VAS (ANOVA, F(1, 21) = 25.4, P < 0.0005), SFMPQ (sensory) (F(1, 22) = 11.2, P = 0.003), and SFMPQ (affective) (F(1, 21) = 10.9, P = 0.008). For VAS, there was significant reduction at 4 weeks (P = 0.001) and 8 weeks (P < 0.0005) compared to baseline. For SFMPQ (sensory), there was significant reduction at 4 weeks (P = 0.01) and 8 weeks (P = 0.006) in scores compared to baselines. For SFMPQ (affective), there was significant reduction at 4 weeks (P = 0.04) and 8 weeks (P = 0.008) in scores compared to baseline. No significant anxiety (F(1, 4) = 1.3, P = 0.32) or depression (F(1, 4) = 0.06, P = 0.82) changes were observed in the HADS. Conclusion: Pregabalin is efficacious in alleviation of pain symptoms related to CSR as a first-line single agent, evaluated by quantitative severity and other experiential scales. No significant mood changes reported in other studies were demonstrated. Somnolence was commonest adverse effect leading to high dropout rates, occurring early even at the lowest dose. The findings suggest the need for further studies of efficacy at lower dosages, particularly in the Asian population.J Clin Med Res. 2014;6(1):66-71doi: http://dx.doi.org/10.4021/jocmr879w
机译:背景:颈椎病(CS)引起的疼痛可能是由退行性椎管狭窄症(颈椎病性脊髓病(CSM))或侧凹损害所致,导致神经根受压(颈椎病性神经根病(CSR))。普瑞巴林在疱疹后神经痛和糖尿病性神经病的随机,安慰剂对照试验中显示有效。我们首次在包括亚洲患者在内的前瞻性研究中评估了其在具有潜在CSR或CSM的CS中的疗效。方法:招募患有CS,CSR或CSM(临床,MRI或电生理证据)并伴有神经性疼痛的患者。我们排除了患有糖尿病,潜在神经系统疾病或以前使用抗癫痫药的患者。服用普瑞巴林75 mg bd持续4周,此后如果视觉模拟量表(VAS)没有减少50%,则剂量增加至150 mg bd持续4周。此外,我们在基线,第4周和第8周监测了简短的麦吉尔疼痛问卷(SFMPQ)。使用医院焦虑和抑郁评分(HADS)在相同的时间轴上监控情绪变化。结果:我们招募了50位患者,其中23位完成了试验。在退出的27名成员中,有12名(44%)是因为失眠。十三名患者(54%)的剂量仍为75毫克,而十一名患者(46%)的剂量已升至每日150毫克。 VAS(ANOVA,F(1,21)= 25.4,P <0.0005),SFMPQ(感官)(F(1,22)= 11.2,P = 0.003)和SFMPQ(情感)与基线相比有显着降低的趋势(F(1,21)= 10.9,P = 0.008)。对于VAS,与基线相比,第4周(P = 0.001)和第8周(P <0.0005)显着降低。对于SFMPQ(感觉),与基线相比,评分在第4周(P = 0.01)和第8周(P = 0.006)有显着降低。对于SFMPQ(情感),与基线相比,评分在第4周(P = 0.04)和在第8周(P = 0.008)显着降低。在HADS中未观察到明显的焦虑(F(1,4)= 1.3,P = 0.32)或抑郁(F(1,4)= 0.06,P = 0.82)变化。结论:普瑞巴林作为一线单一药物可有效缓解与CSR相关的疼痛症状,并通过定量严重程度和其他经验标准进行评估。在其他研究中没有发现明显的情绪变化。嗜睡是最常见的不良反应,导致辍学率高,甚至在最低剂量下也很早就发生。这些发现表明需要对低剂量的疗效进行进一步研究,尤其是在亚洲人群中。 2014; 6(1):66-71doi:http://dx.doi.org/10.4021/jocmr879w

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