Kean Walter F, Bouchard Sylvie, Roderich Gossen E
Department of Rheumatology, Hamilton Health Sciences, McMaster University, Hamilton, Ontario;
Pain Med. 2009 Sep;10(6):1001-11. doi: 10.1111/j.1526-4637.2009.00677.x. Epub 2009 Aug 7.
This analysis assesses the efficacy and safety of treatment with a once-daily oral formulation of tramadol for up to 12 weeks compared with placebo in women with moderate-to-severe pain due to osteoarthritis of the knee.
Two parallel, placebo-controlled phase III clinical trials were analyzed; patients were randomized to a fixed dosage of Tramadol Contramid once a day (OAD) 100, 200, and 300 mg daily, or placebo.
The primary efficacy end points were the percentage difference from baseline of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) subscale scores for pain and physical function, and the patient global rating of pain relief after 12 weeks of maintenance therapy.
The analysis included 405 women receiving tramadol and 280 receiving placebo. At week 12, 179 of 204 women (87.7%) receiving tramadol rated their overall pain relief as effective or very effective compared with 134 of 177 (75.7%) receiving placebo. A time-weighted analysis revealed statistically significant improvements over placebo for all the WOMAC subscale scores across all three dosages. The percentage improvements from baseline of the WOMAC pain scores were significantly better than placebo for the 100-mg (58.8 +/- 37.1%, P = 0.018) and 300-mg (58.9 +/- 38.8%, P = 0.023) treatment arms; however, the 200-mg dosage was not significant (53.0 +/- 38.5%, P = 0.175). The WOMAC physical function scores showed significant improvement for the 100 (56.9 +/- 36.4%, P = 0.009), 200 (54.0 +/- 33.8%, P = 0.034), and 300 mg (53.4 +/- 41.4%, P = 0.043) daily dosages.
For moderate-to-severe pain due to osteoarthritis of the knee, women experience significant analgesia and improvement of physical function over time with treatment with Tramadol Contramid OAD.
本分析评估每日一次口服曲马多制剂治疗长达12周对中度至重度膝骨关节炎疼痛女性患者的疗效和安全性，并与安慰剂进行比较。
分析两项平行、安慰剂对照的III期临床试验；患者被随机分为每日一次固定剂量的曲马多控释片（OAD）100、200和300mg，或安慰剂。
主要疗效终点为维持治疗12周后，西安大略和麦克马斯特大学骨关节炎指数（WOMAC）疼痛和身体功能分量表评分较基线的差异百分比，以及患者对疼痛缓解的总体评价。
分析纳入405例接受曲马多治疗的女性和280例接受安慰剂治疗的女性。在第12周时，204例接受曲马多治疗的女性中有179例（87.7%）将其总体疼痛缓解评为有效或非常有效，而接受安慰剂治疗的177例中有134例（75.7%）。时间加权分析显示，在所有三种剂量下，所有WOMAC分量表评分均较安慰剂有统计学意义的改善。WOMAC疼痛评分较基线的改善百分比在100mg（58.8±37.1%，P = 0.018）和300mg（58.9±38.8%，P = 0.023）治疗组显著优于安慰剂；然而，200mg剂量组无显著差异（53.0±38.5%，P = 0.175）。WOMAC身体功能评分在每日剂量100mg（56.9±36.4%，P = 0.009）、200mg（54.0±33.8%，P = 0.034）和300mg（53.4±41.4%，P = 0.043）时均有显著改善。
对于中度至重度膝骨关节炎疼痛，女性患者使用曲马多控释片OAD治疗后，随着时间推移可获得显著的镇痛效果和身体功能改善。
