Department of Rehabilitation Medicine, The Leonard M. Miller School of Medicine, University of Miami, FL, USA.
Neurology. 2013 Feb 5;80(6):533-9. doi: 10.1212/WNL.0b013e318281546b. Epub 2013 Jan 23.
To assess the efficacy and tolerability of pregabalin for the treatment of central neuropathic pain after spinal cord injury (SCI).
Patients with chronic, below-level, neuropathic pain due to SCI were randomized to receive 150 to 600 mg/d pregabalin (n = 108) or matching placebo (n = 112) for 17 weeks. Pain was classified in relation to the neurologic level of injury, defined as the most caudal spinal cord segment with normal sensory and motor function, as above, at, or below level. The primary outcome measure was duration-adjusted average change in pain. Key secondary outcome measures included the change in mean pain score from baseline to end point, the percentage of patients with ≥30% reduction in mean pain score at end point, patient global impression of change scores at end point, and the change in mean pain-related sleep interference score from baseline to end point. Additional outcome measures included the medical outcomes study-sleep scale and the Hospital anxiety and depression scale.
Pregabalin treatment resulted in statistically significant improvements over placebo for all primary and key secondary outcome measures. Significant pain improvement was evident as early as week 1 and was sustained throughout the treatment period. Adverse events were consistent with the known safety profile of pregabalin and were mostly mild to moderate in severity. Somnolence and dizziness were most frequently reported.
This study demonstrates that pregabalin is effective and well tolerated in patients with neuropathic pain due to SCI.
This study provides class I evidence that pregabalin, 150 to 600 mg/d, is effective in reducing duration-adjusted average change in pain compared with baseline in patients with SCI over a 16-week period (p = 0.003, 95% confidence interval = -0.98, -0.20).
评估普瑞巴林治疗脊髓损伤（SCI）后中枢性神经性疼痛的疗效和耐受性。
将患有慢性、低位、神经性疼痛的 SCI 患者随机分为接受 150 至 600mg/d 普瑞巴林（n = 108）或匹配安慰剂（n = 112）治疗 17 周。疼痛根据损伤的神经水平进行分类，定义为感觉和运动功能正常的最尾端脊髓节段，分为高于、等于或低于损伤水平。主要结局测量是疼痛持续时间调整后的平均变化。主要次要结局测量包括从基线到终点的平均疼痛评分变化、终点时平均疼痛评分降低≥30%的患者比例、终点时患者整体变化印象评分以及从基线到终点的平均与疼痛相关的睡眠干扰评分变化。其他结局测量包括医疗结局研究-睡眠量表和医院焦虑和抑郁量表。
普瑞巴林治疗在所有主要和关键次要结局测量上均显著优于安慰剂。在治疗的早期（第 1 周）就出现了明显的疼痛改善，并持续整个治疗期间。不良反应与普瑞巴林已知的安全性特征一致，大多数为轻度至中度。最常报告的是嗜睡和头晕。
这项研究表明普瑞巴林治疗 SCI 引起的神经性疼痛有效且耐受性良好。
这项研究提供了 I 级证据，表明与基线相比，在 16 周的时间内，150 至 600mg/d 的普瑞巴林可有效减少 SCI 患者疼痛持续时间调整后的平均变化（p = 0.003，95%置信区间 = -0.98，-0.20）。
