Postmenopausal hormone therapy increases risk for venous thromboembolic disease - The heart and estrogen/progestin replacement study
Postmenopausal hormone therapy increases risk for venous thromboembolic disease - The heart and estrogen/progestin replacement study
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DOI：
10.7326/0003-4819-132-9-200005020-00002
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发表时间：
2000-05-02
影响因子：
39.2
通讯作者：
Hulley, S
中科院分区：
文献类型：
--
作者：
Grady, D;Wenger, NK;Hulley, S
背景：使用口服避孕药会增加静脉血栓栓塞的风险，但有关绝经后激素治疗效果的数据有限。目的：确定雌激素加孕激素治疗对绝经后妇女静脉血栓栓塞事件风险的影响。设计：随机、双盲、安慰剂对照试验。地点：美国 20 个临床中心。参与者：2763 名年龄小于 80 岁（平均年龄 67 岁）的绝经后妇女，患有冠心病，但既往没有静脉血栓栓塞症，也没有做过子宫切除术。 干预：结合马雌激素 0.625 毫克，加醋酸甲羟孕酮 2.5 毫克，一片片剂 (n = 1380) 或外观相同的安慰剂 (n = 1383）。测量：记录深静脉血栓或肺栓塞。结果：在平均 4.1 年的随访期间，激素治疗组中的 34 名女性和安慰剂组中的 13 名女性经历了静脉血栓栓塞事件（相对风险，2.7 [95% CI，1.4 至 5.0] [P = 0.003]；超额风险，每 1000 人中有 3.9 人发生女性年 [CI，每 1000 名女性年 1.4 至 6.4]；需要治疗伤害的人数，256 [CI，157 至 692]）。在多变量分析中，患有下肢骨折（相对风险，18.1 [CI，5.4至60.4]）或癌症（相对风险，3.9 [Cl，1.6至9.4]）以及住院手术后90天（相对风险，4.9 [CI，2.4至9.8]）或癌症（相对风险，4.9 [CI，2.4至9.8]）的女性，静脉血栓栓塞的风险增加。非手术住院（相对危险，5.7 [Ct，3.0 至 10.8]）。使用阿司匹林（相对风险，0.5 [CI，0.2至0.8]）或使用他汀类药物（相对风险，0.5 [CI，0.2至0.9]）可降低风险。结论：雌激素加孕激素绝经后治疗会增加患有冠心病的女性发生静脉血栓栓塞的风险。当权衡治疗的风险和益处时，应考虑这种风险。
Background: Oral contraceptive use increases risk for venous thromboembolism, but data on the effect of postmenopausal hormone therapy are limited.Objective: To determine the effect of therapy with estrogen plus progestin on risk for venous thromboembolic events in postmenopausal women.Design: Randomized, double-blind, placebo-controlled trial.Setting: 20 clinical centers in the United States.Participants: 2763 postmenopausal women younger than 80 years of age (mean age, 67 years) who had coronary heart disease but no previous Venous thromboembolism and had not had a hysterectomy.Intervention: Conjugated equine estrogens, 0.625 mg, plus medroxyprogesterone acetate, 2.5 mg, in one tablet (n = 1380) or placebo that was identical in appearance (n = 1383).Measurements: Documented deep venous thrombosis or pulmonary embolism.Results: During an average of 4.1 years of follow-up, 34 women in the hormone therapy group and 13 in the placebo group experienced Venous thromboembolic events (relative hazard, 2.7 [95% CI, 1.4 to 5.0] [P = 0.003]; excess risk, 3.9 per 1000 woman-years [CI, 1.4 to 6.4 per 1000 woman-years]; number needed to treat for harm, 256 [CI, 157 to 692]). In multivariate analysis, the risk for venous thromboembolism was increased among women who had lower-extremity fractures (relative hazard, 18.1 [CI, 5.4 to 60.4]) or cancer (relative hazard, 3.9 [Cl, 1.6 to 9.4]) and for 90 days after inpatient surgery (relative hazard, 4.9 [CI, 2.4 to 9.8]) or nonsurgical hospitalization (relative hazard, 5.7 [Ct, 3.0 to 10.8]). Risk was decreased with aspirin (relative hazard, 0.5 [CI, 0.2 to 0.8]) or statin use (relative hazard, 0.5 [CI, 0.2 to 0.9]).Conclusions: Postmenopausal therapy with estrogen plus progestin increases risk for venous thromboembolism in women with coronary heart disease. This risk should be considered when the risks and benefits of therapy are being weighed.