Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial
Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial
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DOI：
10.1016/j.pain.2004.05.001
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发表时间：
2004-08-01
期刊：
影响因子：
7.4
通讯作者：
Sharma, U
中科院分区：
文献类型：
--
作者：
Rosenstock, J;Michael, TB;Sharma, U
一项随机、双盲、安慰剂对照、平行组、多中心、为期8周的试验（随后为开放标签期）评价了普瑞巴林缓解糖尿病周围神经病变（DPN）相关疼痛的有效性。对于入组，患者必须在基线时有：1- 5年的DPN疼痛史;疼痛评分：40 mm（简明麦吉尔疼痛问卷[SF-MPQ]视觉模拟量表）;平均每日疼痛评分大于或等于4（11分数字疼痛评定量表[0 =无疼痛，10最严重的可能疼痛]）。146例患者随机接受安慰剂（n = 70）或普瑞巴林300 mg/天（n = 76）。主要疗效指标为患者每日日记的终点平均疼痛评分（11分数值疼痛评定量表）。次要指标包括SF-MPQ评分;睡眠干扰评分;患者和临床总体印象变化（PGIC和CGIC）;简明健康调查表-36（SF-36）评分;以及情绪状态概况（POMS）评分。安全性评估包括不良事件的发生率和强度、体格和神经系统检查以及实验室评价。与安慰剂相比，普瑞巴林显著改善了平均疼痛评分（P < 0.0001）;平均睡眠干扰评分（P < 0.0001）; SF-MPQ总评分（P < 0.01）; SF-36躯体疼痛子量表（P < 0.03）; PGIC（P = 0.001）;以及POMS的总情绪障碍和紧张焦虑成分（P < 0.03）。疼痛缓解和睡眠改善在第一周开始，并在整个研究中保持显著性（P < 0.01）。普瑞巴林的耐受性良好，尽管头晕和嗜睡的发生率高于安慰剂。大多数不良事件为轻度至中度，未导致退出。普瑞巴林在减轻DPN相关疼痛方面是安全有效的，也能改善情绪、睡眠障碍和生活质量。(C)2004年国际疼痛研究协会。Elsevier B. V.出版，保留所有权利。
A randomized, double-blind, placebo-controlled, parallel-group, multicenter, 8-week trial (with subsequent open-label phase) evaluated the effectiveness of pregabalin in alleviating pain associated with diabetic peripheral neuropathy (DPN). For enrollment, patients must have had at baseline: 1- to 5-year history of DPN pain; pain score : 40 mm (Short-Form McGill Pain Questionnaire [SF-MPQ] visual analogue scale); average daily pain score of greater than or equal to 4 (11-point numerical pain rating scale [0 = no pain, 10 worst possible pain]). One hundred forty-six (146) patients were randomized to receive placebo (n = 70) or pregabalin 300 mg/day (n 76). Primary efficacy measure was endpoint mean pain score from daily patient diaries (11-point numerical pain rating scale). Secondary measures included SF-MPQ scores; sleep interference scores; Patient and Clinical Global Impression of Change (PGIC and CGIC); Short Form-36 (SF-36) Health Survey scores; and Profile of Mood States (POMS) scores. Safety assessment included incidence and intensity of adverse events, physical and neurological examinations, and laboratory evaluations. Pregabalin produced significant improvements versus placebo for mean pain scores (P < 0.0001); mean sleep interference scores (P < 0.0001); total SF-MPQ score (P < 0.01); SF-36 Bodily Pain subscale (P < 0.03); PGIC (P = 0.001); and Total Mood Disturbance and Tension-Anxiety components of POMS (P < 0.03). Pain relief and improved sleep began during week I and remained significant throughout the study (P < 0.01). Pregabalin was well tolerated despite a greater incidence of dizziness and somnolence than placebo. Most adverse events were mild to moderate and did not result in withdrawal. Pregabalin was safe and effective in decreasing pain associated with DPN, and also improved mood, sleep disturbance, and quality of life. (C) 2004 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.