Boeijinga J K, van Meegen E, van den Ende R, Schook C E, Cohen A F
Centre for Human Drug Research, Leiden University, The Netherlands.
J Clin Pharmacol. 1998 Oct;38(10):966-70. doi: 10.1002/j.1552-4604.1998.tb04394.x.
The objective of this study was to investigate whether the central analgesic tramadol influences the effects of the coumarin anticoagulant phenprocoumon during multiple-dose administration. Nineteen patients receiving long-term anticoagulant therapy who had been in a stable hypothrombinemic state for at least 3 months completed a double-blind, placebo-controlled, crossover study. Tramadol was administered in the usual therapeutic dose of 50 mg three times daily. The average daily phenprocoumon dose was identical for individual patients in both treatment periods. The equivalence ratio (tramadol/placebo) of the international normalized ratio (INR) values was 0.99 (90% confidence interval 0.89-1.10), thus fulfilling predetermined bioequivalence criteria (0.70-1.43). Therefore, tramadol does not affect INR in patients being treated with phenprocoumon. These data suggest a lack of interaction between tramadol and coumarin anticoagulants.
本研究的目的是调查中枢镇痛药曲马多在多剂量给药期间是否会影响香豆素类抗凝剂苯丙香豆素的效果。19名接受长期抗凝治疗且处于稳定低凝血酶原血症状态至少3个月的患者完成了一项双盲、安慰剂对照、交叉研究。曲马多按每日3次、每次50mg的常用治疗剂量给药。两个治疗期内，各患者的苯丙香豆素平均日剂量相同。国际标准化比值（INR）值的等效比（曲马多/安慰剂）为0.99（90%置信区间0.89 - 1.10），因此符合预定的生物等效性标准（0.70 - 1.43）。所以，曲马多不影响接受苯丙香豆素治疗患者的INR。这些数据表明曲马多与香豆素类抗凝剂之间不存在相互作用。
