风险和收益的健康的绝经后妇女雌激素加黄体酮:主要妇女健康倡议随机对照试验的结果。

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罗索乌我,安德森GL,普伦蒂斯RL LaCroix AZ, Kooperberg C, Stefanick ML,杰克逊RD,贝雷斯福德SA霍华德BV,约翰逊KC,柯秦JM, Ockene J

风险和收益的健康的绝经后妇女雌激素加黄体酮:主要妇女健康倡议随机对照试验的结果。

《美国医学协会杂志》上。2002年7月17日,288(3):321 - 33所示。

PubMed ID
12117397 (在PubMed
]
文摘

背景:尽管几十年积累的观测证据,风险和收益的平衡对健康的绝经后妇女激素使用仍不确定。目的:评估主要的健康益处和风险的最常用的组合激素制剂在美国。设计:雌激素加黄体酮的妇女健康倡议,一级预防的随机对照试验(计划时间,8.5年)的16608名50 - 79岁的绝经后妇女与一个完整的子宫在基线招募了美国40个临床中心1993 - 1998。干预措施:参与者收到马结合雌激素,0.625毫克/天,加醋酸甲羟孕酮,2.5 mg / d, 1片(n = 8506)或安慰剂(n = 8102)。主要结果测量:主要结果是冠心病(CHD)(非致死性心肌梗死和冠心病死亡),与浸润性乳腺癌作为主要的不良结果。全球指数总结风险和收益的平衡包括2主要结果+中风,肺栓塞(PE),子宫内膜癌,大肠癌,髋部骨折,由于其他原因和死亡。结果:5月31日,2002年,平均5.2年的随访后,数据和安全监测委员会建议阻止雌激素加黄体酮对安慰剂的审判,因为浸润性乳腺癌的检验统计量超过了阻止边界的不利影响和全球指数统计支持风险超过收益。这个报告包括主要的临床结果数据通过4月30日,2002年。估计风险比率(小时)(名义95%置信区间(CIs))如下:冠心病,1.29(1.02 - -1.63)286例;乳腺癌,1.26(1.00 - -1.59)290例; stroke, 1.41 (1.07-1.85) with 212 cases; PE, 2.13 (1.39-3.25) with 101 cases; colorectal cancer, 0.63 (0.43-0.92) with 112 cases; endometrial cancer, 0.83 (0.47-1.47) with 47 cases; hip fracture, 0.66 (0.45-0.98) with 106 cases; and death due to other causes, 0.92 (0.74-1.14) with 331 cases. Corresponding HRs (nominal 95% CIs) for composite outcomes were 1.22 (1.09-1.36) for total cardiovascular disease (arterial and venous disease), 1.03 (0.90-1.17) for total cancer, 0.76 (0.69-0.85) for combined fractures, 0.98 (0.82-1.18) for total mortality, and 1.15 (1.03-1.28) for the global index. Absolute excess risks per 10 000 person-years attributable to estrogen plus progestin were 7 more CHD events, 8 more strokes, 8 more PEs, and 8 more invasive breast cancers, while absolute risk reductions per 10 000 person-years were 6 fewer colorectal cancers and 5 fewer hip fractures. The absolute excess risk of events included in the global index was 19 per 10 000 person-years. CONCLUSIONS: Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy postmenopausal US women. All-cause mortality was not affected during the trial. The risk-benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases, and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD.

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