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接受皮下注射睾酮或睾酮联合阿那曲唑治疗的女性乳腺癌发病率降低:一项前瞻性观察性研究。

Reduced breast cancer incidence in women treated with subcutaneous testosterone, or testosterone with anastrozole: a prospective, observational study.

机构信息

Millennium Wellness Center, 228 E. Spring Valley Road, Dayton, Ohio 45458, USA; Wright State University Boonshoft School of Medicine, Department of Surgery, 3460 Colonel Glenn Highway, Dayton, Ohio 45435, USA.

出版信息

Maturitas. 2013 Dec;76(4):342-9. doi: 10.1016/j.maturitas.2013.08.002. Epub 2013 Sep 10.

DOI:10.1016/j.maturitas.2013.08.002
PMID:24028858
Abstract

OBJECTIVES

There is evidence that androgens are breast protective and that testosterone therapy treats many symptoms of hormone deficiency in both pre and postmenopausal patients. However, unlike estrogen and progestins, there is a paucity of data regarding the incidence of breast cancer in women treated with testosterone therapy. This study was designed to investigate the incidence of breast cancer in women treated with subcutaneous testosterone therapy in the absence of systemic estrogen therapy.

STUDY DESIGN

This is a 5-year interim analysis of a 10-year, prospective, observational, IRB approved study investigating the incidence of breast cancer in women presenting with symptoms of hormone deficiency treated with subcutaneous testosterone (T) implants or, T combined with the aromatase inhibitor anastrozole (A), i.e., T+A implants. Breast cancer incidence was compared with that of historical controls reported in the literature, age specific Surveillance Epidemiology and End Results (SEER) incidence rates, and a representative, similar age group of our patients used as a 'control' group. The effect of adherence to T therapy was also evaluated.

RESULTS

Since March 2008, 1268 pre and post menopausal women have been enrolled in the study and eligible for analysis. As of March 2013, there have been 8 cases of invasive breast cancer diagnosed in 5642 person-years of follow up for an incidence of 142 cases per 100000 person-years, substantially less than the age-specific SEER incidence rates (293/100000), placebo arm of Women's Health Initiative Study (300/100000), never users of hormone therapy from the Million Women Study (325/100000) and our control group (390/100000). Unlike adherence to estrogen therapy, adherence to T therapy further decreased the incidence of breast cancer (73/100000).

CONCLUSION

T and/or T+A, delivered subcutaneously as a pellet implant, reduced the incidence of breast cancer in pre and postmenopausal women. Evidence supports that breast cancer is preventable by maintaining a T to estrogen ratio in favor of T and, in particular, by the use of continuous T or, when indicated, T+A. This hormone therapy should be further investigated for the prevention and treatment of breast cancer.

摘要

目的

有证据表明雄激素具有保护乳房的作用,并且睾丸激素疗法可治疗绝经前和绝经后患者许多激素缺乏的症状。但是,与雌激素和孕激素不同,关于接受睾丸激素治疗的女性乳腺癌发病率的数据很少。本研究旨在调查在没有全身雌激素治疗的情况下接受皮下睾丸激素治疗的女性乳腺癌的发病率。

研究设计

这是一项为期 10 年的前瞻性、观察性、IRB 批准的研究的 5 年中期分析,该研究调查了患有激素缺乏症的女性(接受皮下睾丸酮(T)植入物治疗,或 T 联合芳香化酶抑制剂阿那曲唑(A),即 T+A 植入物治疗)的乳腺癌发病率。将乳腺癌发病率与文献中报道的历史对照、特定年龄的监测、流行病学和最终结果(SEER)发病率以及我们患者的代表性、相似年龄组作为“对照”组进行比较。还评估了对 T 治疗的依从性的影响。

结果

自 2008 年 3 月以来,已有 1268 名绝经前和绝经后女性参加了该研究,并符合分析条件。截至 2013 年 3 月,在 5642 人年的随访中有 8 例浸润性乳腺癌被诊断出,发病率为每 100000 人年 142 例,远低于特定年龄的 SEER 发病率(293/100000)、妇女健康倡议研究的安慰剂组(300/100000)、百万女性研究的从不使用激素治疗的人群(325/100000)和我们的对照组(390/100000)。与雌激素治疗的依从性不同,睾丸激素治疗的依从性进一步降低了乳腺癌的发病率(73/100000)。

结论

T 和/或 T+A,作为皮下植入物给药,降低了绝经前和绝经后妇女的乳腺癌发病率。有证据表明,通过维持有利于 T 的 T 与雌激素的比值,特别是通过使用连续 T 或在需要时使用 T+A,可以预防乳腺癌。这种激素治疗应进一步研究用于预防和治疗乳腺癌。

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