The University of Queensland, School of Medicine, Herston, Brisbane 4029, Australia The University of Queensland, School of Pharmacy, Pharmacy Australia Centre of Excellence, Woolloongabba, Brisbane 4102, Australia Professor Tess Cramond Multidisciplinary Pain Centre, Royal Brisbane and Women's Hospital, Herston, Brisbane 4029, Australia Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital, Herston, Brisbane 4029, Australia The University of Queensland, Centre for Integrated Preclinical Drug Development, St Lucia Campus, Brisbane 4072, Australia Preventative Health National Research Flagship, Commonwealth Scientific and Industrial Research Organisation - CSIRO Mathematics, Information and Statistics, Royal Brisbane and Women's Hospital, Herston, Brisbane 4029, Australia.
Pain. 2011 Jun;152(6):1279-1288. doi: 10.1016/j.pain.2011.01.055. Epub 2011 Mar 12.
This randomised, double-blind, placebo-controlled trial assessed the efficacy and tolerability of pregabalin to alleviate the neuropathic component of moderate to severe burn pain. Patients aged 18 to 65 years admitted to a burns unit with a 5% or greater total body surface area burn injury were screened to participate in the trial. Using the Neuropathic Pain Scale (NPS), patients scoring 4 or higher on 'hot' pain or 'sharp' pain were invited to participate. Consenting patients were randomly assigned to receive pregabalin or placebo for 28 days with individual dose titration commencing at 75 mg twice daily to a maximum pregabalin dose of 300 mg twice daily. The primary outcome measure was the patients' daily response to the sharp and hot pain of the NPS. Secondary outcome measures included the remaining elements of the NPS, daily opioid requirement, length of hospital stay, pain at 6 months, and side effects of nausea, vomiting, drowsiness and giddiness. For patients administered pregabalin, the primary outcome measures hot (P = .01) and sharp (P = .04) pain were significantly reduced compared with those in patients administered placebo. Secondary outcome measures of itch, unpleasantness, surface pain, and procedural pain were significantly lower (P < .05) in the pregabalin group. Adverse effects were uncommon, with no difference between the treatment groups. There was no significant difference between the pregabalin and placebo treatment groups with respect to opioid consumption, duration of hospital stay, or pain at 6 months. Pregabalin was efficacious and well tolerated in patients after severe burn injury and whose pain was characterised by features of acute neuropathic pain. In this study, pregabalin was well tolerated and significantly reduced several elements of the neuropathic pain scale including hot pain, unpleasantness of the pain, surface pain, and itch, and also significantly reduced procedural pain.
这项随机、双盲、安慰剂对照试验评估了普瑞巴林缓解中重度烧伤疼痛的神经性成分的疗效和耐受性。年龄在 18 至 65 岁之间、烧伤面积达到或超过 5%的烧伤患者，在烧伤科住院治疗时，将接受筛查以参与本试验。采用神经性疼痛量表（NPS），对“热痛”或“刺痛”评分达到 4 分或以上的患者，邀请他们参与试验。同意参与的患者被随机分配接受普瑞巴林或安慰剂治疗，为期 28 天，起始剂量为每日两次 75mg，最大剂量为每日两次 300mg。主要结局测量指标为患者对 NPS 中的刺痛和热痛的每日反应。次要结局测量指标包括 NPS 的其余组成部分、每日阿片类药物需求、住院时间、6 个月时的疼痛以及恶心、呕吐、嗜睡和头晕等副作用。与接受安慰剂治疗的患者相比，接受普瑞巴林治疗的患者的主要结局测量指标（刺痛和热痛）明显降低（P=0.01 和 P=0.04）。普瑞巴林组的次要结局测量指标（瘙痒、不适、表面疼痛和操作痛）也明显降低（P<0.05）。不良反应并不常见，两组之间没有差异。普瑞巴林组和安慰剂组在阿片类药物消耗、住院时间或 6 个月时的疼痛方面没有显著差异。普瑞巴林对严重烧伤后疼痛特征为急性神经性疼痛的患者有效且耐受性良好。在这项研究中，普瑞巴林耐受性良好，显著降低了神经性疼痛量表的几个组成部分，包括热痛、疼痛不适、表面疼痛和瘙痒，还显著降低了操作痛。
