Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials.
Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials.
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DOI：
10.1001/jama.2013.278040
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发表时间：
2013-10-02
影响因子：
120.7
通讯作者：
Wallace, Robert B.
中科院分区：
文献类型：
--
作者：
Manson, JoAnn E.;Chlebowski, Rowan T.;Stefanick, Marcia L.;Aragaki, Aaron K.;Rossouw, Jacques E.;Prentice, Ross L.;Anderson, Garnet;Howard, Barbara V.;Thomson, Cynthia A.;LaCroix, Andrea Z.;Wactawski-Wende, Jean;Jackson, Rebecca D.;Limacher, Marian;Margolis, Karen L.;Wassertheil-Smoller, Sylvia;Beresford, Shirley A.;Cauley, Jane A.;Eaton, Charles B.;Gass, Margery;Hsia, Judith;Johnson, Karen C.;Kooperberg, Charles;Kuller, Lewis H.;Lewis, Cora E.;Liu, Simin;Martin, Lisa W.;Ockene, Judith K.;O'Sullivan, Mary Jo;Powell, Lynda H.;Simon, Michael S.;Van Horn, Linda;Vitolins, Mara Z.;Wallace, Robert B.
绝经期激素治疗继续在临床使用，但问题仍然是关于其风险和效益的慢性疾病预防。提供两项妇女健康倡议（WHI）激素治疗（HT）试验的全面综合概述，并延长干预后随访。27,347名绝经后妇女，年龄50-79岁，在美国40个中心登记。干预措施为子宫完整的女性（N= 16,608）联合马雌激素（CEE， 0.625 mg/天）和醋酸甲羟孕酮（MPA， 2.5 mg/天），子宫切除的女性（N= 10,739）单独使用CEE或安慰剂。干预分别持续5.6年和7.2年（中位数），截至2010年9月30日，累计随访13年。主要疗效和安全性指标分别为冠心病和浸润性乳腺癌。全球指标还包括中风、肺栓塞、结直肠癌、子宫内膜癌、髋部骨折和死亡。次要结果和生活质量也进行了评估。在CEE+MPA的干预阶段，冠心病的风险比（HR）为1.18(95%可信区间[CI] 0.95-1.45)，总体风险大于收益，浸润性乳腺癌、中风、肺栓塞和全球指数增加。其他风险包括增加痴呆（65岁以下女性）、胆囊疾病和尿失禁，而益处包括减少髋部骨折、糖尿病和血管舒缩症状。干预后，大多数风险和益处消失，尽管乳腺癌风险持续升高（累积风险比[HR] =1.28； 95%可信区间，1.11-1.48）。单独对CEE进行干预时，风险和收益更加平衡，冠心病的HR为0.94(0.78-1.14)，卒中和静脉血栓发生率增加，髋部骨折和糖尿病发生率降低，累计随访后，乳腺癌发生率降低（HR=0.79[0.65-0.97]）。两种方案都没有影响全因死亡率。在CEE中，年轻女性（50-59岁）在全因死亡率、心肌梗死和全球指数（按年龄趋势的名义P值<0.05）方面有更有利的结果，但在中风和静脉血栓形成方面则没有。CEE+MPA每年每10,000名妇女的不良事件绝对风险（由全球指数衡量）范围从50-59岁的12例超额到70-79岁的38例，对于CEE，从50-59岁的19例减少到70-79岁的51例超额。两项试验的生活质量结果好坏参半。绝经期激素治疗具有复杂的风险和收益模式。虽然它适用于一些妇女的症状管理，但它用于慢性疾病预防并没有得到世界卫生组织随机试验的支持。临床试验。gov标识符：NCT00000611
Menopausal hormone therapy continues in clinical use but questions remain regarding its risks and benefits for chronic disease prevention. To provide a comprehensive, integrated overview of findings from the two Women’s Health Initiative (WHI) hormone therapy (HT) trials with extended post-intervention follow up. 27,347 postmenopausal women, age 50–79 years, were enrolled at 40 US centers. Interventions were conjugated equine estrogens (CEE, 0.625 mg/day) with medroxyprogesterone acetate (MPA, 2.5 mg/day) for women with an intact uterus (N = 16,608) and CEE alone for women with hysterectomy (N= 10,739), or their placebos. Intervention continued for 5.6 and 7.2 years (median), respectively, with cumulative follow-up of 13 years through September 30, 2010. The primary efficacy and safety outcomes were coronary heart disease (CHD) and invasive breast cancer, respectively. A global index also included stroke, pulmonary embolism, colorectal cancer, endometrial cancer, hip fracture, and deaths. Secondary and quality-of-life outcomes were also assessed. During the intervention phase for CEE+MPA, the hazard ratio (HR) for CHD was 1.18 (95% confidence interval [CI] 0.95–1.45) and overall risks outweighed benefits, with increases in invasive breast cancer, stroke, pulmonary embolism, and the global index. Other risks included increased dementia (in women >65 years), gallbladder disease, and urinary incontinence, while benefits included decreased hip fractures, diabetes, and vasomotor symptoms. Post-intervention, most risks and benefits dissipated, although some elevation in breast cancer risk persisted (cumulative hazard ratio [HR] =1.28; 95% confidence interval, 1.11–1.48). During intervention for CEE alone, risks and benefits were more balanced, with a HR for CHD of 0.94 (0.78–1.14), increased stroke and venous thrombosis, decreased hip fractures and diabetes, and over cumulative follow-up, decreased breast cancer (HR=0.79 [0.65–0.97]). Neither regimen affected all-cause mortality. With CEE, younger women (50–59 years) had more favorable results for all-cause mortality, myocardial infarction, and the global index (nominal P values for trend by age <0.05), but not for stroke and venous thrombosis. Absolute risks of adverse events (measured by the global index) per 10,000 women per year on CEE+MPA ranged from 12 excess cases for age 50–59 to 38 for age 70–79 and, for CEE, from 19 fewer cases for age 50–59 to 51 excess cases for age 70–79. Results for quality of life outcomes in both trials were mixed. Menopausal hormone therapy has a complex pattern of risks and benefits. While appropriate for symptom management in some women, its use for chronic disease prevention is not supported by the WHI randomized trials. clinical trials.gov Identifier: NCT00000611
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共轭性雌激素和乳腺癌的发病率和乳腺癌的死亡率以及子宫切除术后妇女：妇女健康计划的扩展随访随机性安慰剂对照试验。
DOI：
10.1016/s1470-2045(12)70075-x
发表时间：
2012-05
期刊：
The Lancet. Oncology
影响因子：
--
作者：
Anderson GL;Chlebowski RT;Aragaki AK;Kuller LH;Manson JE;Gass M;Bluhm E;Connelly S;Hubbell FA;Lane D;Martin L;Ockene J;Rohan T;Schenken R;Wactawski-Wende J
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Wactawski-Wende J
DOI：
10.1158/1940-6207.capr-11-0185
发表时间：
2011-05
期刊：
Cancer prevention research (Philadelphia, Pa.)
影响因子：
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作者：
Jordan VC;Ford LG
通讯作者：
Ford LG
影响因子：
120.7
作者：
Anderson, GL;Judd, HL;Lopez, AM
通讯作者：
Lopez, AM
影响因子：
158.5
作者：
Chlebowski, RT;Wactawski-Wende, J;Carleton, R
通讯作者：
Carleton, R
DOI：
10.1097/gme.0b013e31819c11e4
发表时间：
2009-07
期刊：
Menopause (New York, N.Y.)
影响因子：
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作者：
Huang AJ;Sawaya GF;Vittinghoff E;Lin F;Grady D
通讯作者：
Grady D