Relief of painful diabetic peripheral neuropathy with pregabalin: A randomized, placebo-controlled trial
Relief of painful diabetic peripheral neuropathy with pregabalin: A randomized, placebo-controlled trial
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DOI：
10.1016/j.jpain.2004.12.007
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发表时间：
2005-04-01
期刊：
影响因子：
4
通讯作者：
Knapp, LE
中科院分区：
文献类型：
--
作者：
Richter, RW;Portenoy, R;Knapp, LE
：这是一项为期 6 周的随机、双盲、多中心研究，评估普瑞巴林治疗疼痛性糖尿病神经病变的疗效。 246 名患有疼痛性糖尿病神经病变的男性和女性接受了普瑞巴林（150 或 600 毫克/天，口服）或安慰剂治疗。主要疗效变量是治疗结束时的平均疼痛评分。功效结果表明，普瑞巴林 600 mg/天可将平均疼痛评分显着降低至 4.3（安慰剂为 5.6，P = 0.0002），并增加了疼痛较基线减轻≥ 50% 的患者比例（安慰剂为 39%，安慰剂为 15%，P = 0.002）。普瑞巴林还显着减少睡眠干扰、过去一周和当前的疼痛强度、感觉和情感疼痛评分以及身体疼痛，并将描述其疼痛为啃咬、恶心、恐惧和惩罚性残忍的患者数量减少≥50%。根据临床和患者总体印象变化量表的评分，接受普瑞巴林 600 mg/天治疗的患者比安慰剂组有更多患者出现改善，分别为 73% vs 45% 和 85% vs 47%。普瑞巴林 150 毫克/天与安慰剂本质上没有什么不同。头晕是最常见的副作用。这些研究结果表明，普瑞巴林 600 毫克/天可安全有效地减轻疼痛和疼痛性糖尿病神经病变的其他相关症状。观点：疼痛性糖尿病周围神经病变是一种具有挑战性的神经性疼痛综合征。这项随机对照试验表明，普瑞巴林是一种与电压门控钙通道的 α(2)-δ 蛋白亚基相互作用的新药，是治疗这种疾病疼痛的有效且安全的方法。 (c) 2005 年，美国疼痛协会。
: This was a 6-week, randomized, double-blind, multicenter study evaluating the efficacy of pregabalin in the treatment of painful diabetic neuropathy. Two hundred forty-six men and women with painful diabetic neuropathy received pregabalin (150 or 600 mg/day by mouth) or placebo. The primary efficacy variable was mean pain score at the end of treatment. Efficacy results indicate that pregabalin 600 mg/day significantly decreased mean pain score to 4.3 (vs 5.6 for placebo, P =.0002) and increased the proportion of patients who had a >= 50% decrease from baseline pain (39% vs 15% for placebo, P =.002). Pregabalin also significantly reduced sleep interference, past week and present pain intensity, sensory and affective pain scores, and bodily pain and decreased by >= 50% the number of patients describing their pain as gnawing, sickening, fearful, and punishing- cruel. More patients receiving pregabalin 600 mg/day than placebo showed improvement, as rated on the Clinical and Patient Global Impression of Change scales, 73% vs 45% and 85% vs 47%, respectively. Pregabalin 150 mg/day was essentially no different from placebo. Dizziness was the most common side effect. These study results show pregabalin 600 mg/day to be safe and effective in reducing the pain and other associated symptoms of painful diabetic neuropathy.Perspective: Painful diabetic peripheral neuropathy is a challenging neuropathic pain syndrome. This randomized controlled trial demonstrates that pregabalin, a new drug that interacts with the alpha(2)-delta protein subunit of the voltage-gated calcium channel, is an efficacious and safe treatment for the pain of this condition. (c) 2005 by the American Pain Society.