Adding ultralow-dose naltrexone to oxycodone enhances and prolongs analgesia: A randomized, controlled trial of oxytrex
Adding ultralow-dose naltrexone to oxycodone enhances and prolongs analgesia: A randomized, controlled trial of oxytrex
复制标题
DOI：
10.1016/j.jpain.2005.01.356
复制
发表时间：
2005-06-01
期刊：
影响因子：
4
通讯作者：
Friedmann, N
中科院分区：
文献类型：
--
作者：
Chindalore, VL;Craven, RA;Friedmann, N
Oxytrex是一种新型药物，它将羟考酮与超低剂量的阿片类拮抗剂纳洛酮结合在一起。超低剂量阿片类拮抗剂已被证明可以增强和延长阿片类镇痛作用，减轻啮齿类动物的阿片耐受和戒断。这项为期3周的11期临床试验评估了Oxytrex在骨关节炎中度至重度疼痛患者中的安全性和镇痛疗效。疼痛评分>= 5的患者接受安慰剂、羟考酮每日4次（qid）、Oxytrex每日4次或Oxytrex每日2次（bid）。所有活性治疗组均接受相同的羟考酮每日总剂量和剂量递增，从10 mg/天开始，以40 mg/天结束。重要的是，Oxytrex bid组接受的纳洛酮日剂量低于Oxytrex qid组（0.002 vs 0.004 mg/天）。Oxytrex bid使疼痛强度降低39%，显著高于安慰剂（P
Oxytrex is a novel drug that combines oxycodone with ultralow-dose naltrexone, an opioid antagonist. Ultralow-dose opioid antagonists have been demonstrated to enhance and prolong opiate analgesia and alleviate opioid tolerance and withdrawal in rodents. This 3-week, Phase 11 clinical trial assessed safety and analgesic efficacy of Oxytrex in patients with moderate to severe pain from osteoarthritis. Patients with a pain score >= 5 received placebo, oxycodone 4 times a day (qid), Oxytrex qid, or Oxytrex twice a day (bid). All active treatment groups received the same total daily dose and dose escalation of oxycodone starting at 10 and ending at 40 mg/day. Importantly, the Oxytrex bid group received a lower daily dose of naltrexone than Oxytrex qid (0.002 vs 0.004 mg/day). Oxytrex bid produced a 39% reduction in pain intensity, which was significantly greater than that of placebo (P