A randomized trial of pregabalin in patients with neuropathic pain due to spinal cord injury
A randomized trial of pregabalin in patients with neuropathic pain due to spinal cord injury
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DOI：
10.1212/wnl.0b013e318281546b
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发表时间：
2013-02-01
期刊：
影响因子：
9.9
通讯作者：
Knapp, Lloyd E.
中科院分区：
文献类型：
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作者：
Cardenas, Diana D.;Nieshoff, Edward C.;Knapp, Lloyd E.
目的：目的：评价普瑞巴林治疗脊髓损伤（spinal cord injury，SCI）后中枢性神经病理性疼痛的疗效和耐受性。方法：将108例SCI后慢性、低位神经病理性疼痛患者随机分为普瑞巴林组（n = 108）和安慰剂组（n = 112），每组108例。根据损伤的神经水平对疼痛进行分类，定义为感觉和运动功能正常的最尾侧脊髓节段，如高于、处于或低于水平。主要结果指标是疼痛持续时间调整后的平均变化。关键的次要结果指标包括从基线到终点的平均疼痛评分的变化，终点时平均疼痛评分降低>= 30%的患者百分比，终点时患者总体印象变化评分，以及从基线到终点的平均疼痛相关睡眠干扰评分的变化。其他结果的措施，包括医疗成果研究睡眠量表和医院焦虑和抑郁Scale.Results：普瑞巴林治疗导致统计学显着改善安慰剂的所有主要和关键的次要结果的措施。疼痛早在第1周就明显改善，并在整个治疗期间持续改善。不良事件与普瑞巴林已知的安全性特征一致，严重程度大多为轻度至中度。嗜睡和头晕是最常见的报告。结论：这项研究表明，普瑞巴林是有效的和良好的耐受性在神经病理性疼痛患者由于SCI。证据分类：这项研究提供了I类证据，普瑞巴林，150至600 mg/d，在16周内，有效降低SCI患者疼痛持续时间调整后的平均变化（与基线相比）（p = 0.003，95%置信区间=-0.98，-0.20）。神经病学（R）2013;80：533-539
Objective: To assess the efficacy and tolerability of pregabalin for the treatment of central neuropathic pain after spinal cord injury (SCI).Methods: 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.Results: 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 weremostly mild tomoderate in severity. Somnolence and dizziness were most frequently reported.Conclusions: This study demonstrates that pregabalin is effective and well tolerated in patients with neuropathic pain due to SCI.Classification of evidence: 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). Neurology (R) 2013;80:533-539