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目的:探讨小剂量经皮给药雌激素与组织选择性雌激素活性调节剂联用对冠心病的一级预防作用。方法:围绝经期有冠心病高危因素者65例,随机分为观察组33例,给予妇舒宁25(17β-雌二醇)1/4贴片和利维爱(替勃隆)1/4片口服,二者序贯合用。对照组32例,予相同面积大小卫生胶布和维生素B11/4片。观察两组患者血压、身高、体重、血脂、血糖、血浆胰岛素、C-反应蛋白、一氧化氮、内皮素-1、雌二醇、孕酮、睾酮及乳腺彩超、经阴道子宫内膜彩超变化。历时5年,第0、1、2、3个月每月复查1次,以后每6个月复查1次。结果:观察组治疗后随着雌二醇水平升高,甘油三酯、总胆固醇、低密度脂蛋白胆固醇、载脂蛋白-B、空腹血浆胰岛素、C-反应蛋白、纤维蛋白原、内皮素-1水平显著下降,胰岛素敏感性指数、一氧化氮水平明显上升(P<0.01)。对照组治疗后冠心痛发病率为36.4%,明显高于观察组(P<0.05)。3例失访,无乳腺癌和子宫内膜癌发生。结论:小剂量经皮给药雌激素与组织选择性雌激素活性调节剂联用可用于围绝经期女性冠心病的一级预防,未见明显癌性不良反应发生。
Objective: To investigate the primary preventive effect of low-dose transdermal estrogen and tissue-selective estrogen activity modulating agent on coronary heart disease. Methods: 65 cases of peri-menopausal women with high risk of coronary heart disease were randomly divided into observation group (33 cases), Fusuning 25 (17β-estradiol) 1/4 patch and Levi (Tibilone) 1 / 4 orally, both sequential use. Control group of 32 cases, to the same size and size of health tape and vitamin B11 / 4 tablets. Blood pressure, height, body weight, blood lipid, blood glucose, plasma insulin, C-reactive protein, nitric oxide, endothelin-1, estradiol, progesterone, testosterone and mammography and transvaginal endometrial ultrasonography were observed in two groups . Lasted 5 years, 0,1,2,3 months a month to review once every 6 months after a review. Results: The levels of triglyceride, total cholesterol, low density lipoprotein cholesterol, apolipoprotein B, fasting plasma insulin, C - reactive protein, fibrinogen, endothelin - 1 levels were significantly decreased, insulin sensitivity index, nitric oxide levels increased significantly (P <0.01). The incidence of coronary heart disease in the control group was 36.4%, which was significantly higher than that in the observation group (P <0.05). Three patients were lost, no breast cancer and endometrial cancer. Conclusion: The combination of low-dose transdermal estrogen and tissue-selective estrogen activity regulators can be used in primary prevention of perimenopausal women with coronary heart disease, and no obvious adverse reactions of cancer occur.