Pregabalin for relief of neuropathic pain associated with diabetic neuropathy:: A randomized, double-blind study
Pregabalin for relief of neuropathic pain associated with diabetic neuropathy:: A randomized, double-blind study
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DOI：
10.1016/j.ejpain.2007.05.003
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发表时间：
2008-02-01
影响因子：
3.6
通讯作者：
Young, James P., Jr.
中科院分区：
文献类型：
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作者：
Toelle, Thomas;Freynhagen, Rainer;Young, James P., Jr.
已发表的七项随机、安慰剂对照的普瑞巴林临床试验显示，普瑞巴林在缓解DPN和PHN的神经病理性疼痛方面具有强大的疗效。在一项为期12周的双盲安慰剂对照试验中，一项关于每日两次普瑞巴林的有效性和安全性的调查纳入了395名患有疼痛DPN的成年人，为期一年。患者被随机分为安慰剂、150、300或600毫克/天的普瑞巴林(n=96、99、99和101)。主要疗效衡量标准是患者每日疼痛日记中终点平均疼痛评分较基线的变化。次要疗效测量包括与疼痛相关的睡眠干扰评分、患者和临床总体变化印象(PGIC，CGIC)和EuroQol健康实用指数(EQ-5D)。每天服用600毫克普瑞巴林的患者疼痛显著减轻，每天服用600毫克普瑞巴林的患者中有46%的人报告说，平均疼痛评分较基线改善了50%(与安慰剂患者的30%相比，p=0.036)。达到这种反应所需的治疗人数为6.3人。普瑞巴林600 mg/天在改善疼痛相关睡眠干扰评分(p=0.003)、改善睡眠抑制指数(p=0.021)和改善睡眠抑制指数(p=0.009)方面明显优于安慰剂。(在这些措施上，每天150或300毫克的普瑞巴林都没有与安慰剂分开，很大程度上是因为在一个国家，代表42%的患者的安慰剂反应非常大。)在改善EQ-5D效用得分方面，所有普瑞巴林剂量均优于安慰剂(所有普瑞巴林剂量与安慰剂相比均为0.0263)。普瑞巴林在所有剂量下耐受性良好；不良反应一般为轻度至中度。普瑞巴林600毫克/天需要伤害(因不良事件而停药)为10.3。(C)2007年欧洲国际疼痛研究协会分会联合会。爱思唯尔有限公司出版。保留所有权利。
Seven published, randomized, placebo-controlled clinical trials with pregabalin have shown robust efficacy for relief of neuropathic pain from DPN and PHN. An investigation of the efficacy and safety of twice daily pregabalin enrolled 395 adults with painful DPN for >= 1 year in a 12-week, double-blind, placebo-con trolled trial. Patients were randomized to placebo, 150, 300, or 600 mg/day pregabalin (n = 96, 99, 99, and 101). Primary efficacy measure was change from baseline in endpoint mean pain score from patients' daily pain diaries. Secondary efficacy measures included pain-related sleep-interference scores, Patient and Clinical Global Impressions of Change (PGIC, CGIC), and the EuroQOL Health Utilities Index (EQ-5D). Statistically significant reduction in pain was observed in patients receiving pregabalin 600 mg/day, and 46%, of patients treated with 600 mg/day pregabalin reported >= 50% improvement in mean pain scores from baseline (vs 30% of placebo patients, p = 0.036). Number needed to treat to achieve Such response was 6.3. Pregabalin 600 mg/day was significantly superior to placebo in improving pain-related sleep-interference scores (p = 0.003), PGIC (p = 0.021), and CGIC (p = 0.009). (Neither pregabalin 150 nor 300 mg/day separated from placebo on these measures, largely because of an atypically large placebo response in one country representing 42% of patients.) All pregabalin dosages were Superior to placebo in improving EQ-5D utility scores (all p >= 0.0263 vs placebo). Pregabalin was well tolerated at all dosages; adverse events were generally mild to moderate. Number needed to harm (discontinuation because of adverse events) was 10.3 for pregabalin 600 mg/day. (c) 2007 European Federation of Chapters of the International Association for the Study of Pain. Published by Elsevier Ltd. All rights reserved.