Efficacy and safety of pregabalin for treating neuropathic pain associated with diabetic peripheral neuropathy: a 14 week, randomized, double-blind, placebo-controlled trial
Efficacy and safety of pregabalin for treating neuropathic pain associated with diabetic peripheral neuropathy: a 14 week, randomized, double-blind, placebo-controlled trial
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DOI：
10.1111/j.1464-5491.2010.03152.x
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发表时间：
2011-01-01
影响因子：
3.5
通讯作者：
Shoji, S.
中科院分区：
文献类型：
--
作者：
Satoh, J.;Yagihashi, S.;Shoji, S.
目的评价普瑞巴林治疗日本糖尿病周围神经病变所致神经病理性疼痛的疗效、安全性和药代动力学。方法采用随机、双盲、安慰剂对照、多中心14周临床试验。日本糖尿病周围神经病变患者(n=317)随机接受安慰剂或普瑞巴林治疗，剂量分别为300或600毫克/天。主要的疗效测量是患者从基线到终点的平均疼痛评分的变化。结果与安慰剂相比，接受300和600 mg/天普瑞巴林治疗的患者疼痛显著减轻(P<；0.05)。每周疼痛评分的改善早在第1周就被观察到，并持续到整个研究期间(在研究结束时，与安慰剂相比，300和600毫克/天的差异分别为-0.63和-0.74)。普瑞巴林在每周睡眠干扰评分、短式麦吉尔疼痛问卷、医疗结果研究-睡眠量表、36项短式健康调查量表以及患者和临床总体印象变化方面都有显著改善。患者对麻木、疼痛和感觉异常的印象也得到了显著改善。关于治疗应答者，每天分别服用300毫克和600毫克的患者中，29.1%和35.6%的患者报告平均疼痛评分改善了50%(安慰剂为21.5%)。普瑞巴林耐受性良好；嗜睡(26%)、头晕(24%)、周围水肿(13%)和体重增加(11%)是最常见的不良事件，一般报道为轻至中度。结论普瑞巴林能有效减轻疼痛并改善因疼痛引起的睡眠障碍，对日本疼痛的DPN患者具有良好的耐受性。
P>AimsTo evaluate the efficacy, safety and pharmacokinetics of pregabalin in treating neuropathic pain associated with diabetic peripheral neuropathy in Japanese patients.MethodsA randomized, double-blind, placebo-controlled, multicentre 14 week clinical trial was conducted. Japanese patients with diabetic peripheral neuropathy (n = 317) were randomized to receive placebo or pregabalin at 300 or 600 mg/day. The primary efficacy measure was a change of mean pain score from baseline to end-point from patients' daily pain diaries.ResultsSignificant reductions in pain were observed in patients treated with pregabalin at 300 and 600 mg/day vs. placebo (P < 0.05). Improvements in weekly pain scores were observed as early as week 1 and were sustained throughout the study period (300 and 600 mg/day difference from placebo at study end-point, -0.63 and -0.74, respectively). Pregabalin produced significant improvements in weekly sleep interference scores, the short-form McGill Pain Questionnaire, the Medical Outcomes Study-Sleep Scale, the 36-item Short-Form Health Survey scale, and the Patient and Clinical Global Impression of Change. Patient impressions of numbness, pain and paraesthesia were also significantly improved. Regarding treatment responders, 29.1 and 35.6% of patients treated with 300 and 600 mg/day, respectively, reported >= 50% improvement in mean pain scores (vs. 21.5% for placebo). Pregabalin was well tolerated; somnolence (26%), dizziness (24%), peripheral oedema (13%) and weight gain (11%) were the most common adverse events and generally were reported as mild to moderate.ConclusionsPregabalin was effective in reducing pain and improving sleep disturbances due to pain, and was well tolerated in Japanese patients with painful DPN.