Boureau Francois, Legallicier Pascale, Kabir-Ahmadi Marmar
Centre d'Evaluation et de Traitement de la Douleur, CHU Saint-Antoine, 184 rue du Fg Saint Antoine, 75571 Paris, France.
Pain. 2003 Jul;104(1-2):323-31. doi: 10.1016/s0304-3959(03)00020-4.
The efficacy and safety of sustained-release tramadol compared to placebo in the treatment of post-herpetic neuralgia were evaluated in a multicenter, randomized, double-blind, parallel-group study in 127 outpatients. Treatment was administrated for 6 weeks. The dose of tramadol could be increased from 100 mg/day to 400 mg/day (300 mg/day in patients more than 75 years old). Groups were compared on changes in pain intensity on a Visual Analogue Scale (VAS) between inclusion and the 6th week of treatment (covariance analysis as main analysis and repeated measures analysis as complementary analysis) in the per protocol (PP) population. The randomized population comprised 127 patients aged 35-85 years, mostly females (72.4%). Groups were comparable at inclusion both in the intent to treat (ITT) population (63 patients in the tramadol group and 62 patients in the placebo group) and in the PP population (53 patients in the tramadol group and 55 patients in the placebo group). Mean pain intensity on day 43 adjusted on day 1 (covariance analysis) was significantly lower in the tramadol group than in the placebo group in both the PP (P=0.0499), and the ITT (P=0.031) populations. The two groups significantly differed on change in pain intensity over time (repeated measures analysis) in the ITT population (P=0.012). The percentage of pain relief over the 6th week was significantly higher in the tramadol group than in the placebo group (P=0.017). During the 6th week, patients in the tramadol group required less rescue medication than patients in the placebo group (P=0.022). No significant difference was found between groups either in pain intensity on a 5-point Verbal Scale (VRS) or in quality of life measurements. Tramadol was administered at an average dosage of 275.5 (89.7) mg/day after a 1-week dose-adaptation period. Tramadol was well tolerated. No notable difference appeared between groups either in the percentage of patients with treatment-associated adverse events (TAAE) (29.7% in the tramadol group and 31.8% in the placebo group) or in the total number of TAAE (31 in the tramadol group and 28 in the placebo group).
在一项针对127名门诊患者的多中心、随机、双盲、平行组研究中，评估了缓释曲马多与安慰剂相比治疗带状疱疹后神经痛的疗效和安全性。治疗为期6周。曲马多剂量可从100毫克/天增至400毫克/天（75岁以上患者为300毫克/天）。在符合方案（PP）人群中，比较两组在纳入时和治疗第6周之间视觉模拟量表（VAS）上疼痛强度的变化（以协方差分析作为主要分析，重复测量分析作为补充分析）。随机分组人群包括127名年龄在35 - 85岁的患者，多数为女性（72.4%）。在意向性治疗（ITT）人群（曲马多组63例患者，安慰剂组62例患者）和PP人群（曲马多组53例患者，安慰剂组55例患者）中，两组在纳入时具有可比性。在PP人群（P = 0.0499）和ITT人群（P = 0.031）中，第43天经第1天调整后的平均疼痛强度（协方差分析），曲马多组显著低于安慰剂组。在ITT人群中，两组在疼痛强度随时间的变化（重复测量分析）上有显著差异（P = 0.012）。曲马多组在第6周的疼痛缓解百分比显著高于安慰剂组（P = 0.017）。在第6周期间，曲马多组患者比安慰剂组患者需要更少的急救药物（P = 0.022）。两组在5分言语量表（VRS）上的疼痛强度或生活质量测量方面均未发现显著差异。经过1周的剂量适应期后，曲马多的平均给药剂量为275.5（89.7）毫克/天。曲马多耐受性良好。在治疗相关不良事件（TAAE）患者百分比（曲马多组为29.7%，安慰剂组为31.8%）或TAAE总数（曲马多组为31起，安慰剂组为28起）方面，两组均未出现显著差异。
