美国学者的一项研究表明，普瑞巴林可有效治疗脊髓损伤所致神经性疼痛，并且耐受性良好。论文于2013年1月23日在线发表于《神经病学》（Neurology）。
此项研究共纳入220例脊髓损伤所致慢性神经性疼痛患者，并随机给予为期17周的普瑞巴林（108例）或安慰剂（112例）治疗。依据损伤神经平面相关性对疼痛加以分类。主要转归指标为持续时间校正的疼痛平均改变。关键性次要转归指标包括基线至终点平均疼痛评分变化、终点时平均疼痛评分降低≥30%的患者百分比、终点时患者全面印象变化评分以及疼痛相关性睡眠干扰平均评分变化。
结果显示，与安慰剂相比，普瑞巴林治疗可显著改善所有主要转归指标和关键性次要转归标准。显著疼痛改善早在治疗1周时即可出现，并且持续至整个治疗期间。不良事件与普瑞巴林已知安全性特征相一致，并且大部分为轻中度。嗜睡和眩晕为最常见不良反应。
A randomized trial of pregabalin in patients with neuropathic pain due to spinal cord injury
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 were mostly mild to moderate 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).
来源：CMT 高晓方 编译
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