Cortes-Prieto J
Maturitas. 1987;Suppl 1:67-72. doi: 10.1016/0378-5122(87)90043-0.
The effects of a new synthetic steroid Org OD 14 on the haemostatic mechanism were investigated in 60 post-menopausal women, randomly allocated to 12 weeks of treatment with either 2.5 mg/day of Org OD 14 or a placebo in a double-blind, group-comparative study. Assessments were made 2 weeks before and just prior to the start of treatment, at weeks 6 and 12 during treatment, and 2 weeks after its cessation. No significant differences between the two groups were found with regard to prothrombin time, kaolin cephalin clotting time (KCCT), clotting factors VII, VIII and X, white blood count (WBC) or transaminases (ASAT, ALAT). The following statistically significant differences were seen in the Org OD 14 group: higher plasminogen, antithrombin III, haemoglobin, haematocrit and platelet count, and increased fibrinolytic activity on fibrin plates, as well as lower fibrinogen and alkaline phosphatase values. These findings indicate that Org OD 14 displays no adverse effects on coagulation, while changes in fibrinolysis seem to be beneficial for post-menopausal women.
在一项双盲、组间对比研究中,对60名绝经后女性进行了研究,以调查一种新型合成类固醇Org OD 14对止血机制的影响。这些女性被随机分配,接受为期12周的治疗,其中一组每天服用2.5毫克Org OD 14,另一组服用安慰剂。在治疗开始前2周和即将开始治疗时、治疗期间的第6周和第12周以及治疗停止后2周进行评估。结果发现,两组在凝血酶原时间、高岭土部分凝血活酶时间(KCCT)、凝血因子VII、VIII和X、白细胞计数(WBC)或转氨酶(谷草转氨酶、谷丙转氨酶)方面均无显著差异。在Org OD 14组中观察到以下具有统计学意义的差异:纤溶酶原、抗凝血酶III、血红蛋白、血细胞比容和血小板计数较高,纤维蛋白平板上的纤溶活性增加,以及纤维蛋白原和碱性磷酸酶值较低。这些发现表明,Org OD 14对凝血没有不良影响,而纤维蛋白溶解的变化似乎对绝经后女性有益。