激素替代疗法治疗后的绝经后女性冠心病：风险增加会消失吗？一项随机试验。
Coronary heart disease in postmenopausal recipients of estrogen plus progestin therapy: does the increased risk ever disappear? A randomized trial.
机构信息
Department of Population Medicine, Harvard Medical School/Harvard Pilgrim Health Care Institute, 133 Brookline Avenue, 6th Floor, Boston, MA 02215, USA.
出版信息
Ann Intern Med. 2010 Feb 16;152(4):211-7. doi: 10.7326/0003-4819-152-4-201002160-00005.
BACKGROUND
Estrogen plus progestin therapy increases the risk for coronary heart disease (CHD) in postmenopausal women. However, this increased risk might be limited to the first years of use and to women who start therapy late in menopause.
OBJECTIVE
To estimate the effect of continuous estrogen plus progestin therapy on CHD risk over time and stratified by years since menopause.
DESIGN
Women's Health Initiative randomized, double-blinded, placebo-controlled trial. (ClinicalTrials.gov registration number: NCT00000611)
SETTING
40 U.S. clinical centers.
PATIENTS
16 608 postmenopausal women with an intact uterus at baseline from 1993 to 1998.
INTERVENTION
Conjugated equine estrogens, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d, or placebo.
MEASUREMENTS
Adherence-adjusted hazard ratios and CHD-free survival curves estimated through inverse probability weighting.
RESULTS
Compared with no use of hormone therapy, the hazard ratio for continuous use of estrogen plus progestin therapy was 2.36 (95% CI, 1.55 to 3.62) for the first 2 years and 1.69 (CI, 0.98 to 2.89) for the first 8 years. For women within 10 years after menopause, the hazard ratios were 1.29 (CI, 0.52 to 3.18) for the first 2 years and 0.64 (CI, 0.21 to 1.99) for the first 8 years, and the CHD-free survival curves for continuous use and no use of estrogen plus progestin crossed at about 6 years (CI, 2 years to 10 years).
LIMITATION
The analysis may not have fully adjusted for joint determinants of adherence and CHD risk. Sample sizes for some subgroup analyses were small.
CONCLUSION
No suggestion of a decreased risk for CHD was found within the first 2 years of estrogen plus progestin use, including in women who initiated therapy within 10 years after menopause. A possible cardioprotective effect in these women who initiated therapy closer to menopause became apparent only after 6 years of use.
PRIMARY FUNDING SOURCE
National Heart, Lung, and Blood Institute.
背景
雌激素加孕激素疗法会增加绝经后妇女患冠心病（CHD）的风险。然而，这种风险增加可能仅限于使用的最初几年，以及绝经后开始治疗较晚的妇女。
目的
估计连续使用雌孕激素治疗对 CHD 风险的影响，并按绝经后时间分层。
设计
妇女健康倡议随机、双盲、安慰剂对照试验。（临床试验.gov 注册号：NCT00000611）
地点
美国 40 个临床中心。
患者
1993 年至 1998 年基线时子宫完整的 16608 名绝经后妇女。
干预措施
结合马雌激素，0.625mg/d，加醋酸甲羟孕酮，2.5mg/d，或安慰剂。
测量
通过逆概率加权估计调整用药依从性的风险比和 CHD 无事件生存曲线。
结果
与不使用激素治疗相比，连续使用雌孕激素治疗的风险比在最初 2 年为 2.36（95%CI，1.55 至 3.62），在最初 8 年为 1.69（CI，0.98 至 2.89）。对于绝经后 10 年内的妇女，风险比在最初 2 年为 1.29（CI，0.52 至 3.18），在最初 8 年为 0.64（CI，0.21 至 1.99），连续使用和不使用雌孕激素的 CHD 无事件生存曲线在大约 6 年（CI，2 年至 10 年）处交叉。
局限性
分析可能没有充分调整用药依从性和 CHD 风险的共同决定因素。一些亚组分析的样本量较小。
结论
在雌孕激素使用的最初 2 年内，包括在绝经后 10 年内开始治疗的妇女，均未发现 CHD 风险降低的迹象。在这些更接近绝经时开始治疗的女性中，只有在使用 6 年后才出现可能的心脏保护作用。
主要资金来源
美国国家心肺血液研究所。
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