PHARMACODYNAMIC EFFECTS OF SINGLE AND REPEATED DOSES OF ORAL SULODEXIDE IN HEALTHY-VOLUNTEERS - A PLACEBO-CONTROLLED STUDY WITH AN ENTERIC-COATED FORMULATION
PHARMACODYNAMIC EFFECTS OF SINGLE AND REPEATED DOSES OF ORAL SULODEXIDE IN HEALTHY-VOLUNTEERS - A PLACEBO-CONTROLLED STUDY WITH AN ENTERIC-COATED FORMULATION
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DOI：
10.1185/03007999309111537
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发表时间：
1993-01-01
影响因子：
2.3
通讯作者：
MILANI, MR
中科院分区：
文献类型：
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作者：
MAURO, M;PALMIERI, GC;MILANI, MR
8名男性和8名女性健康志愿者（平均年龄32 ± 6岁）进行了一项随机、交叉研究，旨在比较100和200 mg/天舒洛地特口服肠溶片对某些纤溶和凝血参数的活性。每日两次剂量单次和重复（持续7天）给药后，在给药后前6小时内检查纤维板试验、Heptest、纤溶酶原激活物抑制剂试验（关于活性和抗原水平）和活化部分凝血活酶时间。舒洛地特的促纤维蛋白溶解和抗血栓形成活性在两种给药方案中均被证实具有显著性，并通过重复给药而增强。另一方面，对aPTT无任何影响证实了口服给药后药物对凝血内源性途径无干扰。未观察到不良反应或事件
Eight male and 8 female healthy volunteers, aged on average 32 +/- 6 years, underwent a randomized, crossover study, aimed at comparing the activity on some fibrinolysis and coagulation parameters of 100 and 200 mg/day of oral sulodexide, administered as enteric-coated tablets. After the single and the repeated (for 7 days) administration of the two daily dosages, the Fibrin Plates test, the Heptest, the Plasminogen Activator Inhibitor test (as to both activity and antigen level) and the activated Partial Thromboplastin Time were checked during the first 6 hours after administration. The pro-fibrinolytic and antithrombotic activity of sulodexide was confirmed to be significant with both dosage schemes and potentiated by repeated administrations. On the other hand, the absence of any influence on aPTT confirmed the lack of interference of the drug, after oral administration, on the intrinsic pathway of coagulation. No adverse reactions or events were observed