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新使用者和长期使用者阴道用雌三醇乳膏的雌三醇血清水平:一项前瞻性观察性研究。

Estriol serum levels in new and chronic users of vaginal estriol cream: A prospective observational study.

机构信息

Department of Urogynaecology, St. George Hospital, School of Women's and Children's Health, University of New South Wales, Sydney, Australia.

Department of Clinical Pharmacology and Toxicology, St. Vincent's Hospital, Sydney, Australia.

出版信息

Neurourol Urodyn. 2020 Apr;39(4):1137-1144. doi: 10.1002/nau.24331. Epub 2020 Apr 9.

DOI:10.1002/nau.24331
PMID:32270905
Abstract

AIMS

To quantify estriol serum concentrations in "new" and "chronic users" of topical estriol cream using quantitative liquid chromatography tandem mass spectrometry.

METHODS

In this singlecentre prospective observational study, postmenopausal women with urogynaecological complaints were enrolled: 40 had not used topical estriol previously ("new users") and 50 had been applying estriol cream for more than 12 weeks ("chronic users"). In "new users," serum estriol levels were measured at baseline and after 12 weeks use. Estriol cream 1 mg/g was used daily for 3 weeks, then twice weekly with applicator (group 1A) or digitally (group 1B) or three times per week digitally (group 1C). "Chronic users" applied the cream twice (n = 7) or three (n = 43) times per week. Serum samples were taken in the morning after using cream the previous night. The main outcome measures were estriol serum concentrations in "new" and "chronic users" of estriol cream.

RESULTS

Baseline serum estriol concentrations were less than 5 pmol/L in all 40 "new users." At 12 weeks, the 12-hour serum estriol levels ranged from less than 5 to 494 pmol/L (median 22.8; Interquartile range [IQR] 9.2-108.5). Seven "new users" had levels more than 100 pmol/L. Most of the 50 "chronic users" also had 12-hour levels less than 100 pmol/L (median 15.1 pmol/L [IQR 2.7-33.9]: three had levels more than 100 pmol/L.

CONCLUSIONS

This study reports serum estriol concentrations in a large number of "new" and "chronic users" of vaginal estriol cream, employing a novel highly sensitive and specific technique. Overall, the results are reassuring: 87% had 12-hour estriol levels less than 100 pmol/L.

摘要

目的

使用定量液相色谱串联质谱法对局部雌三醇乳膏的“新使用者”和“慢性使用者”进行血清雌三醇浓度定量。

方法

在这项单中心前瞻性观察研究中,招募了有尿生殖妇科投诉的绝经后妇女:40 名妇女以前未使用过局部雌三醇(“新使用者”),50 名妇女已使用雌三醇乳膏超过 12 周(“慢性使用者”)。在“新使用者”中,在基线和使用 12 周后测量血清雌三醇水平。雌三醇乳膏 1mg/g 每天使用 3 周,然后每周两次(用涂药器组 1A 或数字组 1B)或每周三次(数字组 1C)使用。“慢性使用者”每周使用乳膏两次(n=7)或三次(n=43)。前一天晚上使用乳膏后,于清晨采集血清样本。主要观察指标为雌三醇乳膏“新使用者”和“慢性使用者”的血清雌三醇浓度。

结果

所有 40 名“新使用者”的基线血清雌三醇浓度均低于 5pmol/L。12 周时,12 小时血清雌三醇水平范围为低于 5 至 494pmol/L(中位数 22.8;四分位距 [IQR] 9.2-108.5)。7 名“新使用者”的水平高于 100pmol/L。大多数 50 名“慢性使用者”的 12 小时水平也低于 100pmol/L(中位数 15.1pmol/L [IQR 2.7-33.9]:3 名水平高于 100pmol/L。

结论

本研究采用新型高灵敏度和特异性技术报告了大量阴道雌三醇乳膏“新使用者”和“慢性使用者”的血清雌三醇浓度。总体而言,结果令人放心:87%的患者 12 小时雌三醇水平低于 100pmol/L。

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