Pascual Maria Luz G, Fleming Rosa Rosanna B, Gana Theophilus J, Vorsanger Gary J
Clinical Development, Biovail Technologies, Ltd., Bridgewater, NJ, USA.
Curr Med Res Opin. 2007 Oct;23(10):2531-42. doi: 10.1185/030079907X233179.
Tramadol ER* is a once-daily oral analgesic for management of moderate-to-moderately severe chronic pain in adults who require around-the-clock treatment of pain. This study evaluated long-term safety of tramadol ER and effectiveness outcomes in the management of chronic, nonmalignant pain.
Patients enrolled directly for approximately 1 year of open-label tramadol ER treatment if they had chronic, nonmalignant pain (n = 919), or 'rolled over' for 38 weeks of open-label tramadol ER treatment if they completed either of two 12-week, placebo-controlled studies of tramadol ER for low back pain (n = 72) or osteoarthritis (n = 61). Tramadol ER was titrated to a dose of 300 mg once daily (patients >or= 75 years) or 300-400 mg once daily (patients < 75 years).
A total of 257 (24%) patients completed the study. Common adverse events, regardless of treatment relationship, were nausea, dizziness (excluding vertigo), and constipation. Mean scores for current pain intensity (from 0 = no pain to 100 = extreme pain) and least, worst, and average pain intensity over the past week improved at every post-baseline visit. At each post-baseline visit, > 50% of patients provided a global assessment rating of good, very good, or excellent. Study limitations were mandatory titration to 400 mg in some patients, concomitant analgesic therapy as a confounding variable, and lack of a placebo comparator.
Individualized dose titration and limiting once-daily therapy with tramadol ER to the maximum recommended daily dose of 300 mg may balance tolerability and analgesic effects of tramadol ER in patients with chronic, nonmalignant pain.
缓释曲马多*是一种每日一次的口服镇痛药，用于需要全天候治疗疼痛的成人中度至中度重度慢性疼痛的管理。本研究评估了缓释曲马多的长期安全性以及在慢性非恶性疼痛管理中的有效性结果。
患有慢性非恶性疼痛的患者（n = 919）直接入组接受约1年的开放标签缓释曲马多治疗，或者如果他们完成了两项为期12周的曲马多缓释片治疗腰痛（n = 72）或骨关节炎（n = 61）的安慰剂对照研究中的任何一项，则“转入”接受38周的开放标签缓释曲马多治疗。缓释曲马多滴定至每日一次300 mg的剂量（年龄≥75岁的患者）或每日一次300 - 400 mg的剂量（年龄<75岁的患者）。
共有257名（24%）患者完成了研究。无论与治疗的关系如何，常见的不良事件为恶心、头晕（不包括眩晕）和便秘。在每次基线后访视时，当前疼痛强度（从0 = 无疼痛到100 = 极度疼痛）以及过去一周的最小、最严重和平均疼痛强度的平均评分均有所改善。在每次基线后访视时，超过50%的患者给出了良好、非常好或优秀的总体评估评分。研究的局限性在于一些患者必须滴定至400 mg、作为混杂变量的联合镇痛治疗以及缺乏安慰剂对照。
个体化剂量滴定以及将缓释曲马多的每日一次治疗限制在最大推荐日剂量300 mg，可能会平衡缓释曲马多在慢性非恶性疼痛患者中的耐受性和镇痛效果。
