Richter W, Barth H, Flohé L, Giertz H
Arzneimittelforschung. 1985;35(11):1742-4.
In a multicenter study 153 in- and outpatients suffering from severe pain were treated for three weeks with capsules containing 50 mg 1-(m-methoxyphenyl)-2-(dimethylaminomethyl)-cyclohexan-1-ol (tramadol, Tramal). The daily dosage was limited to 400 mg. At the end of the third week the patients received in a randomized double-blind manner 1.6 mg naloxone or saline (both i.m.) to evaluate the risk of developing dependence during the 3-week tramadol treatment (precipitation test). A total of 109 patients completed the trial. Development of tolerance was not observed as was evident from a constant daily tramadol dose associated with constant analgesia. The median net withdrawal scores for the naloxone treated group (mean = 0, Xmin = 0, Xmax = 13) and for the saline treated group (mean = 0, Xmin = 0, Xmax = 5) indicate absence of dependence. The outcome of the study thus suggests that tramadol under the conditions described does not induce dependence.
在一项多中心研究中，153名患有重度疼痛的门诊和住院患者接受了为期三周的治疗，治疗药物为含有50毫克1-（间甲氧基苯基）-2-（二甲基氨基甲基）-环己醇（曲马多，奇曼丁）的胶囊。每日剂量限制在400毫克。在第三周结束时，患者以随机双盲方式接受1.6毫克纳洛酮或生理盐水（均为肌肉注射），以评估在为期3周的曲马多治疗期间产生依赖性的风险（激发试验）。共有109名患者完成了试验。未观察到耐受性的发展，这从与持续镇痛相关的恒定每日曲马多剂量中可以明显看出。纳洛酮治疗组（均值=0，最小值=0，最大值=13）和生理盐水治疗组（均值=0，最小值=0，最大值=5）的中位净戒断评分表明不存在依赖性。因此，该研究结果表明，在所描述的条件下曲马多不会诱发依赖性。
