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首页> 外文期刊>The journal of family planning and reproductive health care >Does hormone replacement therapy cause breast cancer? An application of causal principles to three studies: part 3. The Women's Health Initiative: unopposed estrogen.
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Does hormone replacement therapy cause breast cancer? An application of causal principles to three studies: part 3. The Women's Health Initiative: unopposed estrogen.

机译：激素替代疗法会导致乳腺癌吗？因果原理在三项研究中的应用：第三部分。妇女健康倡议：雌激素抵抗。

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BACKGROUND: Studies from the Women's Health Initiative have reported an increased risk of breast cancer in users of estrogen plus progestogen. Among users of estrogen alone an increased risk was not observed. OBJECTIVE: To evaluate the evidence for unopposed estrogen. METHODS: In a related article (Part 2) the authors apply generally accepted causal criteria to the findings for estrogen plus progestogen. Here (Part 3) the authors apply the criteria to the findings for unopposed estrogen, as reported in a clinical trial, and in combined data from the trial and an observational study. RESULTS: In the clinical trial, after 7.1 years of follow-up the relative risk (RR) of invasive breast cancer for women assigned to estrogen was 0.77 in an 'intention-to-treat' analysis (95% CI 0.59-1.01) and 0.67 (95% CI 0.47-0.97) in an 'as treated' analysis; after 10.7 years the risk reduction persisted. Time order was correctly specified; detection bias was minimal; in the 'as treated' analysis confounding was unlikely; duration-response and internal consistency could be evaluated only to a limited extent because of scanty data; the findings were discordant with increased risks observed in the Collaborative Reanalysis and the Million Women Study; biological plausibility could not be assessed. In the combined analysis, among women who had previously used estrogen soon after the menopause there was no clear evidence of either a reduction or an increase in the risk of breast cancer among women assigned to estrogen during the trial, or among women who were using estrogen in the observational study when follow-up commenced. The combined analysis did not satisfy the criteria of time order, bias, confounding, statistical stability and strength of association, duration-response, and internal consistency; biological plausibility could not be assessed. CONCLUSIONS: The evidence from the clinical trial suggests that unopposed estrogen does not increase the risk of breast cancer, and may even reduce it. The latter possibility, however, is based on statistically borderline evidence.
机译：背景：妇女健康倡议组织的研究报告说，使用雌激素和孕激素的女性患乳腺癌的风险增加。在单独使用雌激素的人群中，未观察到增加的风险。目的：评估雌激素抵抗的证据。方法：在相关文章（第2部分）中，作者将普遍接受的因果标准应用于雌激素和孕激素的发现。在这里（第3部分），作者将标准应用于临床试验中报告的无雌激素的发现，以及试验和观察性研究的综合数据。结果：在临床试验中，经过7.1年的随访，在“意向性治疗”分析中，分配给雌激素的女性的浸润性乳腺癌相对风险（RR）为0.77（95％CI 0.59-1.01），而0.67（95％CI 0.47-0.97）的分析结果; 10.7年后，风险降低持续存在。时间顺序已正确指定;检测偏差极小;在“按治疗情况”分析中，混淆的可能性不大;由于数据不足，只能在有限的程度上评估持续时间响应和内部一致性;这些发现与在协作再分析和《百万妇女研究》中观察到的增加的风险不一致;无法评估生物学合理性。在综合分析中，在绝经后不久以前使用过雌激素的妇女中，没有明确的证据表明试验期间分配雌激素的妇女或使用雌激素的妇女患乳腺癌的风险降低或增加。在观察性研究中何时开始随访。组合分析不满足时间顺序，偏差，混淆，统计稳定性和关联强度，持续时间响应和内部一致性的标准;无法评估生物学合理性。结论：临床试验的证据表明，雌激素水平升高不会增加患乳腺癌的风险，甚至可能降低患乳腺癌的风险。但是，后一种可能性是基于统计学的临界证据。

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