Lesser H, Sharma U, LaMoreaux L, Poole R M
University of Rochester School of Medicine & Dentistry, Rochester, NY, USA.
Neurology. 2004 Dec 14;63(11):2104-10. doi: 10.1212/01.wnl.0000145767.36287.a1.
Pregabalin, an alpha2-delta ligand with analgesic, anxiolytic, and anticonvulsant activity, has been evaluated for treatment of neuropathic pain. The authors assessed the efficacy and tolerability of pregabalin (75, 300, 600 mg/day) vs placebo in patients with diabetic peripheral neuropathy (DPN).
Patients with a 1- to 5-year history of DPN and average weekly pain score of > or =4 on an 11-point numeric pain-rating scale were enrolled in a 5-week, double-blind, multicenter, placebo-controlled study. Patients (n = 338) were randomized to receive one of three doses of pregabalin or placebo TID. Pregabalin 600 mg/day was titrated over 6 days; lower doses were initiated on day 1.
Patients in the 300- and 600-mg/day pregabalin groups showed improvements in endpoint mean pain score (primary efficacy measure) vs placebo (p = 0.0001). Improvements were also seen in weekly pain score, sleep interference score, patient global impression of change, clinical global impression of change, SF-McGill Pain Questionnaire, and multiple domains of the SF-36 Health Survey. Improvements in pain and sleep were seen as early as week 1 and were sustained throughout the 5 weeks. Responders (patients with > or =50% reduction in pain compared to baseline) were 46% (300 mg/day), 48% (600 mg/day), and 18% (placebo). Pregabalin was well tolerated with a low discontinuation rate. The most common adverse events were dizziness and somnolence.
In patients with diabetic peripheral neuropathy, pregabalin demonstrated early and sustained improvement in pain and a beneficial effect on sleep, which were confirmed by positive patient global impression. Pregabalin was well tolerated at all doses.
普瑞巴林是一种具有镇痛、抗焦虑和抗惊厥活性的α2-δ配体，已被评估用于治疗神经性疼痛。作者评估了普瑞巴林（75、300、600毫克/天）与安慰剂相比治疗糖尿病性周围神经病（DPN）患者的疗效和耐受性。
将患有1至5年DPN病史且在11点数字疼痛评分量表上平均每周疼痛评分≥4的患者纳入一项为期5周的双盲、多中心、安慰剂对照研究。患者（n = 338）被随机分配接受三种剂量的普瑞巴林或安慰剂中的一种，每日三次。600毫克/天的普瑞巴林在6天内滴定；较低剂量在第1天开始使用。
与安慰剂相比，300毫克/天和600毫克/天普瑞巴林组患者的终点平均疼痛评分（主要疗效指标）有所改善（p = 0.0001）。每周疼痛评分、睡眠干扰评分、患者总体变化印象、临床总体变化印象、SF-麦吉尔疼痛问卷以及SF-36健康调查的多个领域也有改善。疼痛和睡眠的改善最早在第1周出现，并在整个5周内持续。反应者（与基线相比疼痛减轻≥50%的患者）分别为46%（300毫克/天）、48%（600毫克/天）和18%（安慰剂）。普瑞巴林耐受性良好，停药率低。最常见的不良事件是头晕和嗜睡。
在糖尿病性周围神经病患者中，普瑞巴林在疼痛方面显示出早期且持续的改善，并对睡眠有有益影响，这得到了患者总体积极印象的证实。所有剂量的普瑞巴林耐受性均良好。
