Messa G L, Franchi M, Auteri A, Di Perri T
Department of Internal Medicine, University of Siena, Italy.
Int J Clin Pharmacol Res. 1993;13(5):263-73.
The efficacy and safety of Triflusal capsules given to patients at thrombogenetic risk because of platelet hyperaggregation were investigated in a controlled study involving 15 patients (9 males and 6 females, mean age 65.7 years) who were given 300 mg/day of Triflusal during the first 5 days and 600 mg/day during the following 5 days. Subsequently, after 7 days of wash-out all these patients received placebo for 10 days, one capsule for the first 5 days and 2 capsules for the following 5 days. The platelet antiaggregant activity of the drug was evaluated by means of Born's platelet activation test. Specific tests were also made to assess the effect of this substance on platelet release and the coagulation system. The safety was evaluated by measuring the most important clinical chemistry and clinical haematology indexes of haematopoietic, hepatic, renal and metabolic functions. Arterial blood pressure and heart rate values were also recorded. All the 15 patients completed the study. It was found that the Triflusal treatment led to a significant mean reduction of the indexes chosen as markers of thrombophilia or platelet hyperaggregation in vivo. It did not affect the normal haemostatic-coagulation process and was well tolerated by the patients. The subsequent placebo treatment did not induce any platelet antiaggregant effects.
在一项对照研究中，对15名因血小板高聚集而有血栓形成风险的患者给予曲氟尿苷胶囊，研究其疗效和安全性。这15名患者（9名男性和6名女性，平均年龄65.7岁），在最初5天给予每日300毫克曲氟尿苷，随后5天给予每日600毫克。之后，经过7天的洗脱期，所有这些患者接受10天的安慰剂治疗，前5天每天1粒胶囊，后5天每天2粒胶囊。通过博恩血小板活化试验评估该药物的血小板抗聚集活性。还进行了特定测试，以评估该物质对血小板释放和凝血系统的影响。通过测量造血、肝脏、肾脏和代谢功能的最重要临床化学和临床血液学指标来评估安全性。还记录动脉血压和心率值。所有15名患者均完成了研究。结果发现，曲氟尿苷治疗导致体内所选作为血栓形成倾向或血小板高聚集标志物的指标平均显著降低。它不影响正常的止血凝血过程，且患者耐受性良好。随后的安慰剂治疗未产生任何血小板抗聚集作用。
