Richter W, von Arnim B, Giertz H
MMW Munch Med Wochenschr. 1981 Mar 27;123(13):517-20.
A new administration form of tramadol (50 mg) was compared in a multicenter double-blind trial with pentazocine (50 mg) and with placebo in patients with acute pains. Each patient received a test preparation once. The preparations were available in identical capsules. During the five-hour observation period the effect on the intensity of pain was recorded with reference to a scale and the undesirable side effects noted. Tramadol was shown to have an analgesic effect about equal to that of the comparative preparation. Both analgesics were superior in effect to the placebo, as was expected. The incidence of side effects from tramadol was less than that with the comparative substance, even if both analgesics had a higher incidence of side effects than the placebo. The results confirm earlier experience obtained with parenteral application of tramadol.
在一项多中心双盲试验中,对曲马多(50毫克)的一种新剂型与喷他佐辛(50毫克)及安慰剂进行了比较,受试对象为急性疼痛患者。每位患者仅接受一次试验制剂。制剂均制成相同胶囊。在5小时观察期内,参照一个量表记录对疼痛强度的影响,并记录不良副作用。结果表明,曲马多的镇痛效果与对照制剂相当。正如预期的那样,两种镇痛药的效果均优于安慰剂。曲马多的副作用发生率低于对照药物,即便两种镇痛药的副作用发生率均高于安慰剂。这些结果证实了早期经胃肠外应用曲马多所获得的经验。