Tramadol Hydrochloride Extended-Release Once-Daily in the Treatment of Osteoarthritis of the Knee and/or Hip: A Double-Blind, Randomized, Dose-Ranging Trial
Tramadol Hydrochloride Extended-Release Once-Daily in the Treatment of Osteoarthritis of the Knee and/or Hip: A Double-Blind, Randomized, Dose-Ranging Trial
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DOI：
10.1097/mjt.0b013e3181cec307
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发表时间：
2011-05-01
影响因子：
4.2
通讯作者：
Fleming, R. Rosanna B.
中科院分区：
文献类型：
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作者：
DeLemos, Byron P.;Xiang, Jim;Fleming, R. Rosanna B.
这项为期 12 周的多中心、随机、双盲、安慰剂对照、剂量范围试验评估了曲马多 ER（缓释曲马多）治疗骨关节炎疼痛的效果。患有膝关节和/或髋关节骨关节炎且基线疼痛强度在 100 毫米视觉模拟量表上≥ 40（0 = 无疼痛，100 = 极度疼痛）的成人接受每日一次的曲马多缓释片 100 mg (n = 201)、200 mg (n = 199) 或 300 mg (n = 199)，塞来昔布 200 mg (n = 202；测试模型敏感性）或安慰剂（n = 200）。共同主要疗效变量是西安大略大学和麦克马斯特大学骨关节炎指数 (WOMAC) 疼痛分量表、WOMAC 身体功能分量表和患者疾病活动的总体评估。与安慰剂相比，曲马多缓释片 300 mg 显着改善患者总体评估评分（P
This 12-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial evaluated tramadol ER (extended-release tramadol) in the management of osteoarthritis pain. Adults with knee and/or hip osteoarthritis and baseline pain intensity of >= 40 on a 100-mm visual analog scale (0 = no pain, 100 = extreme pain) received once-daily tramadol ER 100 mg (n = 201), 200 mg (n = 199), or 300 mg (n = 199), celecoxib 200 mg (n = 202; to test model sensitivity), or placebo (n = 200). Coprimary efficacy variables were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, WOMAC physical function subscale, and patient global assessment of disease activity. Tramadol ER 300 mg significantly improved patient global assessment scores compared with placebo (P