Treatment of urogenital atrophy with low-dose estradiol: preliminary results
Treatment of urogenital atrophy with low-dose estradiol: preliminary results
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DOI：
10.1097/00042192-200205000-00006
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发表时间：
2002-05-01
影响因子：
2.7
通讯作者：
Klein, KO
中科院分区：
文献类型：
--
作者：
Santen, RJ;Pinkerton, JV;Klein, KO
目的：确定阴道给药雌二醇 (E-2) 的最低剂量，该剂量可逆转泌尿生殖道萎缩的体征和症状，但不会显着增加血浆 E-2 水平。设计：单盲、单组研究，以确定阴道雌激素剂量递减对泌尿生殖道萎缩症状、阴道 pH 值以及阴道和尿道细胞学的影响。使用问卷来评估主观阴道和尿道症状。客观测量包括在临床研究单位获得的阴道和尿道细胞学、pH、子宫内膜活检以及 24 小时循环血浆黄体生成素、卵泡刺激素 (FSH)、E-2 和雌酮水平。使用超灵敏酵母生物测定法测定循环 E-2 水平，检测限为 0.02 pg/mL。单独施用媒介物后 24 小时内、初始阴道 E-2 剂量后第一天、每日 E-2 施用 3 周后以及每周两次施用另外 9 周后获得测量结果。结果：从接受 10 杯剂量 E-2 研究的前 7 名受试者中，根据预先定义的标准，100% 有反应。阴道细胞学检查显示第 3 周和第 12 周时有统计学改善。 12周后尿道细胞学检查有统计学改善。在第 3 周和第 12 周，阴道 pH 值从绝经后水平下降至绝经前水平。百分之八十二的症状得到治愈或改善。子宫内膜仍然萎缩。循环E-2水平保持在绝经后3-10 pg/mL的范围内。结论：10杯剂量的阴道E，有效治疗了7名女性的泌尿生殖萎缩，并且不会引起子宫内膜增生或增加E-2水平。
Objective: To determine the lowest dosage of vaginally administered estradiol (E-2) that reverses signs and symptoms of urogenital atrophy but does not substantially increase plasma E-2 levels.Design: Single-blind, single-arm study to determine the effects of de-escalating doses of vaginal estrogen on symptoms of urogenital atrophy, vaginal pH, and vaginal and urethral cytology. A questionnaire was used to assess subjective vaginal and urethral symptoms. Objective measurements included vaginal and urethral cytology, pH, endometrial biopsy, and 24-h circulating plasma luteinizing hormone, follicle-stimulating hormone (FSH), E-2 and estrone levels obtained in a Clinical Research Unit. Circulating E-2 levels were assayed with an ultrasensitive yeast bioassay with a detection limit of 0.02 pg/mL. Measurements were obtained over a 24-h period after administration of vehicle alone, on day I after the initial vaginal E-2 dosage, after 3 weeks of daily E-2 administration, and after an additional 9 weeks of twice weekly administration.Results: From the first seven subjects studied at a 10-mug dose of E-2, 100% responded according to predefined criteria. Vaginal cytology showed statistical improvement at 3 and 12 weeks. Urethral cytology was statistically improved after 12 weeks. Vaginal pH decreased from postmenopausal to premenopausal levels at both 3 and 12 weeks. Eighty-two percent of symptoms were cured or improved. Endometrium remained atrophic. Circulating E-2 levels remained within the postmenopausal range of 3-10 pg/mL.Conclusion: A 10-mug dose of vaginal E, effectively treated urogenital atrophy in seven women and did not cause endometrial hyperplasia or increase E-2 levels.