Effects of tibolone and continuous combined hormone replacement therapy on parameters in the clotting cascade: a multicenter, double-blind, randomized study

Effects of tibolone and continuous combined hormone replacement therapy on parameters in the clotting cascade: a multicenter, double-blind, randomized study
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DOI:
10.1016/s0015-0282(00)00587-2
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发表时间:
2000-07-01
影响因子:
6.7
通讯作者:
Bennink, HJTC
Bennink, HJTC
中科院分区:
医学2区
文献类型:
--
作者:
Winkler, UH;Altkemper, R;Bennink, HJTC

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目的:确定替勃龙和连续联合 HRT (ccHRT) 对凝血级联参数的影响。设计:随机、双盲研究。地点:德国一所大学医院诊所的止血科。患者:60 名健康绝经后妇女。干预措施:29 名受试者接受替勃龙(2.5 mg/d)治疗,31 名受试者接受含雌二醇的口服 ccHRT 治疗。 (2 mg/d) + 雌三醇 (1 mg/d) + 醋酸炔诺酮 (1 mg/d)。主要结果指标:对基线时以及治疗 12 周和 24 周后凝血级联参数的影响。结果:替勃龙增加纤溶参数,但不显着改变凝血参数。 ccHRT 治疗对纤维蛋白溶解和凝血参数产生刺激作用。替勃龙表现出更强的 VII 因子活性降低作用; AT-III、蛋白 C 活性和蛋白 S 活性降低较少;活化的部分凝血活酶时间、纤溶酶原和纤溶酶原-抗纤溶酶原复合物更强的增加;并且 D-二聚体的增加比 ccHRT 少。两种制剂均能类似地减少更年期症状,而替勃龙比 ccHRT 表现出更少的乳房症状。 结论:本研究证实,替勃龙和 ccHRT 在较小程度上也能将止血参数改变为更具纤溶特性,这可能会降低静脉血栓形成的风险。 (Fertil Steril(R) 2000;74:10-19。(C) 2000 年,美国生殖医学会)。
Objective: To determine the effects of tibolone and continuous combined HRT (ccHRT) on parameters in the clotting cascade.Design: Randomized, double-blind study.Setting: Hemostasis unit of a university hospital clinic in Germany.Patient(s): Sixty healthy postmenopausal women.Intervention(s): Twenty-nine subjects were treated with tibolone (2.5 mg/d) and 31 with oral ccHRT containing estradiol (2 mg/d) + estriol (1 mg/d) + norethindrone acetate (1 mg/d).Main Outcome Measure(s): Effects on parameters in the clotting cascade at baseline and after 12 and 24 weeks of treatment.Result(s): Tibolone increased fibrinolysis parameters without significantly altering coagulation parameters. Treatment with ccHRT resulted in a stimulating effect on parameters of both fibrinolysis and coagulation. Tibolone showed a stronger reduction of factor VII activity; less reduction of AT-III, protein C activity, and protein S activity; stronger increase of the activated partial thromboplastin time, plasminogen and plasminogen-antiplasminogen complexes; and less increase of D-Dimer than ccHRT. Both preparations similarly reduced climacteric complaints, whereas tibolone showed less breast complaints than ccHRT.Conclusion(s): This study confirms that tibolone, and to a lesser extent also ccHRT, changes hemostasis parameters toward a more fibrinolytic profile, which may diminish the risk of venous thrombosis. (Fertil Steril(R) 2000;74:10-19. (C) 2000 by American Society for Reproductive Medicine).