Parkin D E, Smith D, Al Azzawi F, Lindsay R, Hart D M
Maturitas. 1987 Apr;9(1):95-101. doi: 10.1016/0378-5122(87)90057-0.
98 post-menopausal women were randomly allocated to either Org OD 14 [(7 alpha, 17 alpha)-17-hydroxy-7-methyl-19-norpregn-5(10)-en-20-yn-3-one] 2.5 mg/day or placebo. Treatment was continued for up to 6 yr. Any thromboembolic episode that occurred was recorded. Prothrombin time (PT), partial thromboplastin time (PTT), factor VII level and factor X level were measured prior to treatment and at yearly intervals. Antithrombin III level was measured in the last two yr of the study. There was one cerebrovascular accident after 3 months of placebo therapy but no other thromboembolic episodes. No significant difference was found between the effects of Org OD 14 and placebo with regard to any clotting factors at any time interval, although factor VII and factor X levels were consistently lower in the OD 14 group than in the placebo group. Antithrombin III levels measured after 5 and 6 yr were significantly higher (P less than 0.01) in the OD 14 group, suggesting a reduced risk of thrombosis in the treatment group.
98名绝经后女性被随机分为两组,分别每日服用2.5毫克的Org OD 14(即[(7α, 17α)-17-羟基-7-甲基-19-去甲孕-5(10)-烯-20-炔-3-酮])或安慰剂。治疗持续长达6年。记录发生的任何血栓栓塞事件。在治疗前及每年测量凝血酶原时间(PT)、部分凝血活酶时间(PTT)、因子VII水平和因子X水平。在研究的最后两年测量抗凝血酶III水平。安慰剂治疗3个月后发生1例脑血管意外,但无其他血栓栓塞事件。在任何时间间隔,Org OD 14和安慰剂对任何凝血因子的影响均未发现显著差异,尽管OD 14组的因子VII和因子X水平始终低于安慰剂组。在第5年和第6年测量时,OD 14组的抗凝血酶III水平显著更高(P<0.01),表明治疗组血栓形成风险降低。