Hendrix Susan L, Wassertheil-Smoller Sylvia, Johnson Karen C, Howard Barbara V, Kooperberg Charles, Rossouw Jacques E, Trevisan Maurizio, Aragaki Aaron, Baird Alison E, Bray Paul F, Buring Julie E, Criqui Michael H, Herrington David, Lynch John K, Rapp Stephen R, Torner James
Department of Obstetrics and Gynecology, Wayne State University School of Medicine/Hutzel Women's Hospital, Detroit, MI, USA.
Circulation. 2006 May 23;113(20):2425-34. doi: 10.1161/CIRCULATIONAHA.105.594077. Epub 2006 May 15.
The Women's Health Initiative (WHI) Estrogen Alone trial assessed the balance of benefits and risks of hormone use in healthy postmenopausal women. The trial was stopped prematurely because there was no benefit for coronary heart disease and an increased risk of stroke. This report provides a thorough analysis of the stroke finding using the final results from the completed trial database.
The WHI Estrogen Alone hormone trial is a multicenter, double-blind, placebo-controlled, randomized clinical trial in 10,739 women aged 50 to 79 years who were given daily conjugated equine estrogen (CEE; 0.625 mg; n=5310) or placebo (n=5429). During an average follow-up of 7.1 years, there were 168 strokes in the CEE group and 127 in the placebo group; 80.3% of strokes were ischemic. For all stroke the intention-to-treat hazard ratio [HR] (95% CI) for CEE versus placebo was 1.37 (1.09 to 1.73). The HR (95% CI) was 1.55 (1.19 to 2.01) for ischemic stroke and 0.64 (0.35, 1.18) for hemorrhagic stroke. The HRs indicate excess risk of ischemic stroke was apparent in all categories of baseline stroke risk, including younger and more recently menopausal women and in women with prior or current use of statins or aspirin.
CEE increases the risk of ischemic stroke in generally healthy postmenopausal women. The excess risk appeared to be present in all subgroups of women examined, including younger and more recently menopausal women. There was no convincing evidence to suggest that CEE had an effect on the risk of hemorrhagic stroke.
女性健康倡议（WHI）单纯雌激素试验评估了健康绝经后女性使用激素的利弊平衡。该试验提前终止，因为对冠心病无益处且中风风险增加。本报告使用完整试验数据库的最终结果对中风发现进行了全面分析。
WHI单纯雌激素激素试验是一项多中心、双盲、安慰剂对照的随机临床试验，纳入了10739名年龄在50至79岁的女性，她们被每日给予结合马雌激素（CEE；0.625毫克；n = 5310）或安慰剂（n = 5429）。在平均7.1年的随访期间，CEE组有168例中风，安慰剂组有127例中风；80.3%的中风为缺血性。对于所有中风，CEE与安慰剂相比的意向性治疗风险比[HR]（95%CI）为1.37（1.09至1.73）。缺血性中风的HR（95%CI）为1.55（1.19至2.01），出血性中风的HR为0.64（0.35，1.18）。HR表明，在所有基线中风风险类别中，包括年轻和近期绝经的女性以及既往或目前使用他汀类药物或阿司匹林的女性，缺血性中风的额外风险都很明显。
CEE增加了一般健康绝经后女性缺血性中风的风险。在所检查的所有女性亚组中似乎都存在额外风险，包括年轻和近期绝经的女性。没有令人信服的证据表明CEE对出血性中风风险有影响。
