Harati Y, Gooch C, Swenson M, Edelman S, Greene D, Raskin P, Donofrio P, Cornblath D, Sachdeo R, Siu C O, Kamin M
Baylor College of Medicine and Veterans Affairs Medical Center, Houston, TX 77030, USA.
Neurology. 1998 Jun;50(6):1842-6. doi: 10.1212/wnl.50.6.1842.
The objective of this study was to evaluate the efficacy and safety of tramadol in treating the pain of diabetic neuropathy.
The pain of diabetic neuropathy is a major cause of morbidity among these patients and treatment, as with other small-fiber neuropathies, is often unsatisfactory. Tramadol is a centrally acting analgesic for use in treating moderate to moderately severe pain.
This multicenter, outpatient, randomized, double-blind, placebo-controlled, parallel-group study consisted of a washout/screening phase, during which all analgesics were discontinued, and a 42-day double-blind treatment phase. A total of 131 patients with painful diabetic neuropathy were treated with tramadol (n=65) or placebo (n=66) tramadol, which were administered as identical capsules in divided doses four times daily. The primary efficacy analysis compared the mean pain intensity scores in the tramadol and placebo groups obtained at day 42 of the study or at the time of discontinuation. Secondary efficacy assessments were the pain relief rating scores and a quality of life evaluation based on daily activities and sleep characteristics.
Tramadol, at an average dosage of 210 mg/day, was significantly (p < 0.001) more effective than placebo for treating the pain of diabetic neuropathy. Patients in the tramadol group scored significantly better in physical (p=0.02) and social functioning (p=0.04) ratings than patients in the placebo group. No statistically significant treatment effects on sleep were identified. The most frequently occurring adverse events with tramadol were nausea, constipation, headache, and somnolence.
The results of this placebo-controlled trial showed that tramadol was effective and safe in treating the pain of diabetic neuropathy.
本研究旨在评估曲马多治疗糖尿病性神经病变疼痛的疗效和安全性。
糖尿病性神经病变疼痛是这些患者发病的主要原因，与其他小纤维神经病变一样，治疗往往不尽人意。曲马多是一种中枢性镇痛药，用于治疗中度至中度重度疼痛。
这项多中心、门诊、随机、双盲、安慰剂对照、平行组研究包括一个洗脱/筛查阶段，在此期间停用所有镇痛药，以及一个为期42天的双盲治疗阶段。共有131例糖尿病性神经病变疼痛患者接受曲马多（n = 65）或安慰剂（n = 66）治疗，曲马多以相同胶囊形式分剂量每日四次给药。主要疗效分析比较了研究第42天或停药时曲马多组和安慰剂组的平均疼痛强度评分。次要疗效评估包括疼痛缓解评分以及基于日常活动和睡眠特征的生活质量评估。
曲马多平均剂量为210mg/天，在治疗糖尿病性神经病变疼痛方面比安慰剂显著更有效（p < 0.001）。曲马多组患者在身体功能（p = 0.02）和社会功能（p = 0.04）评分上显著优于安慰剂组患者。未发现对睡眠有统计学显著的治疗效果。曲马多最常出现的不良事件是恶心、便秘、头痛和嗜睡。
这项安慰剂对照试验的结果表明，曲马多治疗糖尿病性神经病变疼痛有效且安全。
