Health outcomes after stopping conjugated equine estrogens among postmenopausal women with prior hysterectomy: a randomized controlled trial.

Health outcomes after stopping conjugated equine estrogens among postmenopausal women with prior hysterectomy: a randomized controlled trial.
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DOI:
10.1001/jama.2011.382
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发表时间:
2011-04-06
影响因子:
120.7
通讯作者:
Wactawski-Wende, Jean
Wactawski-Wende, Jean
中科院分区:
医学1区
文献类型:
--
作者:
LaCroix, Andrea Z.;Chlebowski, Rowan T.;Manson, JoAnn E.;Aragaki, Aaron K.;Johnson, Karen C.;Martin, Lisa;Margolis, Karen L.;Stefanick, Marcia L.;Brzyski, Robert;Curb, J. David;Howard, Barbara V.;Lewis, Cora E.;Wactawski-Wende, Jean

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妇女健康倡议单用雌激素试验在7.1年(平均)随访后提前停止。干预后的健康结果尚未报告。研究2009年8月前子宫切除术后10.7(平均)年随访后,与随机化至结合马雌激素(CEE)治疗相关的健康结局。干预阶段是一项在10,739名年龄在50-79岁的美国绝经后妇女中进行的CEE(0.625 mg/天)或安慰剂的双盲、安慰剂对照、随机试验,既往行子宫切除术。在计划的试验完成日期后,对7645名(78%)提供书面同意的存活受试者继续进行随访。主要结局为CHD和浸润性乳腺癌。风险和获益的全球指数包括这2个终点加上卒中、肺栓塞、结直肠癌、髋部骨折和死亡。分配至CEE组与安慰剂组的女性的干预后风险与CHD的干预期相似(CEE组的年发生率为0.64%,安慰剂组为0.67%;风险比(HR)=0.97,95% CI 0.75-1.25),乳腺癌(0.26% vs. 0.34%; HR=0.75,0.51-1.09)和总死亡率(1.47% vs. 1.48%; HR=1.00,CI 0.84-1.18)。卒中(0.36% vs. 0.41%; HR=0.89,0.64-1.24)、深静脉血栓形成(0.17% vs. 0.27%; HR=0.63,0.41-0.98)和髋部骨折(0.36% vs. 0.28%; HR=1.27,0.88-1.82)的干预后风险发生变化。在整个随访期间,CEE组的乳腺癌发病率持续较低(0.27% vs. 0.35%; HR=0.77,0.62-0.95)。与老年女性相比,年轻女性在CHD(年龄相互作用p =0.049)、总MI(p-相互作用p =0.007)、结直肠癌(p-相互作用p =0.04)、总死亡率(p-相互作用p =0.04)和总体指数(p-相互作用p =0.009)方面的健康结局更有利。在绝经后子宫切除术后随访10.7年的妇女中,CEE使用中位数为5.9年与CHD、深静脉血栓形成、卒中、髋部骨折、结直肠癌或总死亡率的风险增加或减少无关。乳腺癌的风险持续下降。
The Women’s Health Initiative Estrogen-alone Trial was stopped early after 7.1 years (mean) follow-up. Postintervention health outcomes have not been reported. To examine health outcomes associated with randomization to conjugated equine estrogen (CEE) treatment in women with prior hysterectomy after 10.7 (mean) years follow-up through August 2009. The intervention phase was a double-blind, placebo-controlled, randomized trial of CEE, 0.625 mg/day or placebo in 10,739 US postmenopausal women aged 50–79 years with prior hysterectomy. Follow-up continued after the planned trial completion date among 7645 (78%) surviving participants who provided written consent. The primary outcomes were CHD and invasive breast cancer. A global index of risks and benefits included these 2 endpoints plus stroke, pulmonary embolism, colorectal cancer, hip fracture, and death. Postintervention risks for women assigned to CEE vs. placebo were similar to the intervention period for CHD (annualized rates 0.64% in CEE vs. 0.67% in placebo; hazard ratio (HR)=0.97, 95% CI 0.75–1.25), breast cancer (0.26% vs. 0.34%; HR=0.75, 0.51–1.09), and total mortality (1.47% vs. 1.48%; HR=1.00, CI 0.84–1.18). Postintervention risks changed for stroke (0.36% vs. 0.41%; HR=0.89, 0.64–1.24), deep vein thrombosis (0.17% vs. 0.27%; HR=0.63, 0.41–0.98), and hip fracture (0.36% vs. 0.28%; HR=1.27, 0.88–1.82). Over the entire follow-up, lower breast cancer incidence in the CEE group persisted (0.27% vs. 0.35%; HR=0.77, 0.62–0.95). Health outcomes were more favorable for younger compared to older women for CHD (p for age-interaction=0.049), total MI (p-interaction=0.007), colorectal cancer (p-interaction=0.04), total mortality (p-interaction =0.04), and global index (p-interaction=0.009). Among postmenopausal women with prior hysterectomy followed for 10.7 years, CEE use for a median of 5.9 years was not associated with an increased or decreased risk of CHD, deep vein thrombosis, stroke, hip fracture, colorectal cancer, or total mortality. A decreased risk of breast cancer persisted.
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