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芳香酶抑制剂相关阴道萎缩的乳腺癌患者局部应用睾酮:I/II 期研究。

Topical testosterone for breast cancer patients with vaginal atrophy related to aromatase inhibitors: a phase I/II study.

机构信息

Warren Alpert School of Medicine at Brown University, Providence, Rhode Island, USA.

出版信息

Oncologist. 2011;16(4):424-31. doi: 10.1634/theoncologist.2010-0435. Epub 2011 Mar 8.

DOI:10.1634/theoncologist.2010-0435
PMID:21385795
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3228118/
Abstract

PURPOSE

Controversy exists about whether vaginal estrogens interfere with the efficacy of aromatase inhibitors (AIs) in breast cancer patients. With the greater incidence of vaginal atrophy in patients on AIs, a safe and effective nonestrogen therapy is necessary. We hypothesized that vaginal testosterone cream could safely treat vaginal atrophy in women on AIs.

METHODS

Twenty-one postmenopausal breast cancer patients on AIs with symptoms of vaginal atrophy were treated with testosterone cream applied to the vaginal epithelium daily for 28 days. Ten women received a dose of 300 μg, 10 received 150 μg, and one was not evaluable. Estradiol levels, testosterone levels, symptoms of vaginal atrophy, and gynecologic examinations with pH and vaginal cytology were compared before and after therapy.

RESULTS

Estradiol levels remained suppressed after treatment to <8 pg/mL. Mean total symptom scores improved from 2.0 to 0.7 after treatment (p < .001) and remained improved 1 month thereafter (p = .003). Dyspareunia (p = .0014) and vaginal dryness (p <.001) improved. The median vaginal pH decreased from 5.5 to 5.0 (p = .028). The median maturation index rose from 20% to 40% (p < .001). Although improvement in total symptom score was similar for both doses (-1.3 for 300 μg, -0.8 for 150 μg; p = .37), only the 300-μg dose was associated with improved pH and maturation values.

CONCLUSIONS

A 4-week course of vaginal testosterone was associated with improved signs and symptoms of vaginal atrophy related to AI therapy without increasing estradiol or testosterone levels. Longer-term trials are warranted.

摘要

目的

关于阴道雌激素是否会影响乳腺癌患者芳香化酶抑制剂(AIs)的疗效存在争议。由于接受 AIs 治疗的患者阴道萎缩的发生率更高,因此需要一种安全有效的非雌激素治疗方法。我们假设阴道睾酮乳膏可以安全治疗接受 AIs 治疗的女性的阴道萎缩。

方法

21 名接受 AIs 治疗且有阴道萎缩症状的绝经后乳腺癌患者每天接受阴道上皮应用睾酮乳膏治疗 28 天。10 名女性接受 300μg 剂量,10 名接受 150μg 剂量,1 名不可评估。治疗前后比较雌二醇水平、睾酮水平、阴道萎缩症状以及 pH 值和阴道细胞学的妇科检查。

结果

治疗后雌二醇水平仍被抑制至<8pg/mL。治疗后总症状评分从 2.0 分改善至 0.7 分(p<0.001),此后 1 个月仍保持改善(p=0.003)。性交困难(p=0.0014)和阴道干燥(p<0.001)均得到改善。阴道 pH 值中位数从 5.5 降至 5.0(p=0.028)。成熟指数中位数从 20%升至 40%(p<0.001)。尽管两种剂量(300μg 为-1.3,150μg 为-0.8)的总症状评分改善相似(p=0.37),但只有 300μg 剂量与 pH 值和成熟值的改善相关。

结论

为期 4 周的阴道睾酮治疗与改善与 AI 治疗相关的阴道萎缩的体征和症状相关,而不会增加雌二醇或睾酮水平。需要进行更长时间的试验。

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Intravaginal dehydroepiandrosterone (Prasterone), a physiological and highly efficient treatment of vaginal atrophy.阴道内使用脱氢表雄酮(普拉睾酮),是一种治疗阴道萎缩的生理性且高效的方法。
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Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women.阴道内脱氢表雄酮(普拉睾酮)对绝经后女性性欲和性功能障碍的影响。
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Sex hormone levels, breast cancer risk, and cancer receptor status in postmenopausal women: the ORDET cohort.绝经后女性的性激素水平、乳腺癌风险及癌症受体状态:ORDET队列研究
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