Fragen R J, Kouzmanoff C, Caldwell N J
J Clin Pharmacol. 1983 May-Jun;23(5-6):219-26. doi: 10.1002/j.1552-4604.1983.tb02728.x.
Efficacy and safety of the analgesic ciramadol in the management of postoperative pain was evaluated in 139 healthy patients given single, double-blind, intramuscular injections of either 30 mg ciramadol, 60 mg ciramadol, 10 mg morphine or 0.9% saline on the first or second postoperative day. Differences in pain intensity and relief of pain, changes from baseline on a pain analog scale, percentage of patients with moderate or greater pain relief, and cumulative treatment failures were measured for 6 hours after injection. Morphine proved to be superior to all other treatments. Neither dose of ciramadol could be statistically differentiated from placebo. During the first hour after administration, some measurements showed that 30 mg ciramadol was superior to 60 mg ciramadol. Patients experienced little or no drowsiness in any of the four groups, and other side effects were transient and required no specific therapy. Some patients experienced an acute increase in pain intensity after administration of 60 mg ciramadol; this possibly represents antagonism of the residual effect of the previous narcotic. This study must be interpreted with the knowledge that ciramadol, an agonist-antagonist analgesic, was administered to patients who had been receiving narcotic analgesics before entering the study. Future studies of ciramadol given as the sole analgesic may more clearly define its efficacy in the management of postoperative pain.
在139例健康患者中评估了镇痛药环拉马多治疗术后疼痛的疗效和安全性，这些患者在术后第1天或第2天接受单剂量、双盲、肌内注射30mg环拉马多、60mg环拉马多、10mg吗啡或0.9%生理盐水。在注射后6小时测量疼痛强度和疼痛缓解程度的差异、疼痛模拟量表相对于基线的变化、中度或更大程度疼痛缓解的患者百分比以及累积治疗失败情况。结果显示吗啡优于所有其他治疗。两种剂量的环拉马多在统计学上均与安慰剂无差异。在给药后的第1小时内，一些测量结果表明30mg环拉马多优于60mg环拉马多。四组患者中几乎没有或没有出现嗜睡情况，其他副作用是短暂的，无需特殊治疗。一些患者在给予60mg环拉马多后疼痛强度急性增加；这可能代表对先前使用的麻醉药残留效应的拮抗作用。由于本研究是在进入研究前一直接受麻醉性镇痛药治疗的患者中给予环拉马多（一种激动 - 拮抗型镇痛药），所以对本研究结果的解读必须考虑到这一点。未来将环拉马多作为唯一镇痛药的研究可能会更清楚地界定其在治疗术后疼痛方面的疗效。
