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目的 :评价曲马多作为一种辅助治疗用于因患骨关节炎而骨骼肌肉疼痛 ,并在服用非甾体类抗炎药时产生突破性疼痛的患者时的有效性。方法 :选取在服用非甾体类抗炎药时产生突破性疼痛的成年关节炎患者进行单中心 ,平行 ,对照使用安慰剂的 2相实验。在 2 4小时的开放标记相中 ,患者除日常非甾体抗炎药外先服用 1 0 0mg曲马多 ,而后每 6小时服用 5 0mg曲马多 ,禁止用其他镇痛药。符合试验标准并愿意继续治疗者随机分到曲马多组或安慰剂组 ,进行为期 1 3天的双盲试验。非甾体抗炎药可以继续使用。主要有效终止点为由于治疗失败而退出试验的时间 (即不能充分缓解疼痛 ,或不能进行日常活动 )。结果 :曲马多组 (2 5 0mg/天 )由于不能充分缓解疼痛而退出试验的时间比安慰剂组时间长 (P =0 .0 6 6 )。在双盲相试验结束后 ,曲马多治疗组患者在静息时的疼痛明显减轻 (P =0 .0 46 ) ,另外 ,曲马多治疗组患者在活动时的疼痛也明显减轻 (P =0 .0 5 9)。曲马多组和安慰剂组在疼痛程度和日常活动能力上没有显著差别。曲马多组患者对治疗的整体评价 (P =0 .0 2 2 )和调查者对情况改善的整体评分 (P =0 0 0 4)明显优于安慰剂组。结论 :曲马多作为一种辅助手段在治疗因骨关节炎所致肌肉骨骼疼痛而服用非甾体抗炎药的患者的突
PURPOSE: To evaluate the effectiveness of tramadol as an adjuvant therapy for patients with osteoarthritis and skeletal muscle pain and developing breakthrough pain when taking non-steroidal anti-inflammatory drugs. METHODS: Single-center, parallel, and placebo-controlled 2-phase experiments were selected for adult arthritis patients who developed breakthrough pain when taking NSAIDs. In a 24-hour open-label phase, patients received 100 mg of tramadol daily except for NSAIDs and 50 mg of tramadol every 6 hours. No other analgesics were prescribed. Patients who met the test criteria and were willing to continue treatment were randomized to either tramadol or placebo for a 13-day double-blind trial. Non-steroidal anti-inflammatory drugs can continue to use. The primary effective termination point is the time (ie failure to adequately relieve pain, or inability to perform daily activities) to withdraw from the trial due to treatment failure. RESULTS: Tramadol (250 mg daily) withdrawn from the trial longer than placebo for inadequate pain relief (P = .06 6). At the end of the double-blind phase, tramadol-treated patients had significantly reduced pain at rest (P = .046), and pain during activity in the tramadol-treated patients was also significantly reduced (P = 0 .0 5 9). There was no significant difference in the level of pain and daily activity between the tramadol and placebo groups. The overall assessment of treatment (p = .022) in the tramadol group and the overall improvement in the investigators’ condition (p = 0 0 0 4) were significantly better than those in the placebo group. CONCLUSIONS: Tramadol, as an adjunct to the treatment of patients with non-steroidal anti-inflammatory drugs due to osteoarthritis-induced musculoskeletal pain