The effect of tibolone and continuous combined conjugated equine oestrogens plus medroxyprogesterone acetate on progression of carotid intima-media thickness: the Osteoporosis Prevention and Arterial effects of tiboLone (OPAL) study.
替勃龙和连续联合结合马雌激素加醋酸甲羟孕酮对颈动脉内膜中层厚度进展的影响: 替勃龙 (OPAL) 研究的骨质疏松症预防和动脉效应。

摘要

AIMS:At the time of the design of the Osteoporosis Prevention and Arterial effects of tiboLone (OPAL) study in 1996, oral hormone therapy (HT) was assumed to reduce cardiovascular risk. The evidence mainly came from the effects of combined conjugated equine oestrogens plus medroxyprogesterone acetate (CEE/MPA) therapy. Other HT regimes had not been studied widely. Tibolone, a selective tissue oestrogenic activity regulator, has several effects on cardiovascular risk factors, one of which is HDL lowering. Because the overall effect of tibolone on cardiovascular risk was unknown, the OPAL study was designed.
METHODS AND RESULTS:The OPAL study was a three-arm, randomized, placebo-controlled, double-blind study to determine the effect of tibolone (2.5 mg daily) and of CEE/MPA (0.625/2.5 mg daily) over 3 years on progression of carotid intima-media thickness (CIMT) in 866 healthy post-menopausal women. The women were recruited from six US and five European centres. The primary outcome was change in mean common CIMT. Annual common CIMT progression rates in the tibolone and CEE/MPA groups were higher than in the placebo group: 0.0077 mm [95% confidence interval (CI) 0.0051-0.0103] in the tibolone group, 0.0074 mm (0.0048-0.0099) in the CEE/MPA group, and 0.0035 mm (0.009-0.0061) in the placebo group. The differences with placebo (0.0042 mm/year for tibolone and 0.0039 mm/year for CEE/MPA) were statistically significant. HDL cholesterol increased in CEE/MPA group and was lowered in the tibolone group.
CONCLUSION:Both tibolone and CEE/MPA showed increased progression of common CIMT. Translation of the increased common CIMT progression of the CEE/MPA group into cardiovascular disease risk could not fully explain the observed increased cardiovascular risk as observed in the Women's Health Initiative study. This suggests that the net effect of tibolone and CEE/MPA on cardiovascular events may depend on the combined effects on the arterial wall, clotting factors, and possibly inflammation.

译文

目的: 在 1996年替勃龙 (OPAL) 骨质疏松症预防和动脉效应研究的设计中,口服激素疗法 (HT) 被认为可以降低心血管风险。证据主要来自结合马雌激素加醋酸甲羟孕酮 (CEE/MPA) 治疗的效果。其他 HT 制度尚未得到广泛研究。替勃龙是一种选择性的组织雌激素活性调节剂,对心血管危险因素有多种作用,其中之一是降低高密度脂蛋白。因为替勃龙对心血管风险的总体影响未知,所以设计了蛋白石研究。
方法和结果: 澳普研究是一项三臂、随机、安慰剂对照、双盲研究,以确定替勃龙的效果 (每天 2.5 毫克) 和 CEE/MPA (每天 0.625 毫克/2.5 毫克) 对 866 名绝经后健康妇女颈动脉内膜中层厚度 (CIMT) 进展的影响。这些妇女是从六个美国和五个欧洲中心招募的。主要结果是平均普通 CIMT 的变化。替勃龙组和 CEE/MPA 组的年常见 CIMT 进展率高于安慰剂组: 0.0077毫米 [95% 置信区间 (CI) 0.0051-0.0103] 在替勃龙组, CEE/MPA 组为 0.0074毫米 (0.0048-0.0099),安慰剂组为 0.0035毫米 (0.009-0.0061)。安慰剂组 (替勃龙为 0.0042毫米/年,CEE/MPA 为 0.0039毫米/年) 的差异具有统计学意义。CEE/MPA 组高密度脂蛋白胆固醇升高,替勃龙组降低。
结论: 替勃龙和 CEE/MPA 均显示普通 CIMT 进展增加。将 CEE/MPA 组增加的常见 CIMT 进展转化为心血管疾病风险不能完全解释在妇女健康倡议研究中观察到的心血管风险增加。这表明替勃龙和 CEE/MPA 对心血管事件的净影响可能取决于对动脉壁、凝血因子以及可能的炎症的综合影响。

tibolone

妇产 绝经后疾病 药物
概述  :  

替勃龙(商品名利维爱)是荷兰欧加农(Organon)公司在上世纪60年代研究生产的药物,最早用于治疗骨质疏松症。因其临床作用很快被批准作为激素替代治疗(HRT)药物,用于缓解妇女绝经后更年期症状,可以有效防止骨质丢失,不引起子宫内膜增生,且不刺激乳房组织生长,不增加冠心病的危险。现已在80多个国家上市。替勃龙可产生三种代谢产物,在体内不同部位产生不同激素效果。目前已经了解激素对绝经后妇女心血管系统、骨骼、乳房、子宫内膜、中枢神经系统(CNS)、绝经症状和性生活质量等方面的作用。 药

tibolone  英 [tɪbəʊ'ləʊn] 美 [tɪboʊ'loʊn]

释    义   n. 替勃龙;甲异炔诺酮;利维爱

例    句   Tibolone, a synthetic selective tissue estrogenic activity regulator ( STEAR), has estrogenic, progestogenic, and androgenic effects, the authors write.  替勃龙,是一种合成的选择性组织雌激素活性调节因子(简称STEAR),具有雌激素,促黄体素和雄激素的作用。


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