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术前局部应用雌激素治疗是否会加重绝经后症状性盆腔器官脱垂女性的脱垂相关症状?一项随机对照、双盲、安慰剂对照、多中心研究。

Does preoperative locally applied estrogen treatment facilitate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse? A randomised controlled double-masked, placebo-controlled, multicentre study.

机构信息

Department of General Gynaecology and Gynaecologic Oncology, Medical University of Vienna, Vienna, Austria.

Department of Anaesthesiology, Medical University of Vienna, Vienna, Austria.

出版信息

BJOG. 2021 Dec;128(13):2200-2208. doi: 10.1111/1471-0528.16894. Epub 2021 Sep 21.

DOI:10.1111/1471-0528.16894
PMID:34464489
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9293194/
Abstract

OBJECTIVE

To evaluate whether locally applied vaginal estrogen affects prolapse-associated complaints compared with placebo treatment in postmenopausal women prior to surgical prolapse repair.

DESIGN

Randomised, double-masked, placebo-controlled, multicentre study.

SETTING

Urogynaecology unit at the Medical University of Vienna and University Hospital of Tulln.

POPULATION

Postmenopausal women with symptomatic pelvic organ prolapse and planned surgical prolapse repair.

METHODS

Women were randomly assigned local estrogen cream or placebo cream 6 weeks preoperatively.

MAIN OUTCOME MEASURES

The primary outcome was differences in subjective prolapse-associated complaints after 6 weeks of treatment prior to surgery, assessed with the comprehensive German pelvic floor questionnaire. Secondary outcomes included differences in other pelvic floor-associated complaints (bladder, bowel or sexual function).

RESULTS

Out of 120 women randomised, 103 (86%) remained for the final analysis. After 6 weeks of treatment the prolapse domain score did not differ between the estrogen and the placebo groups (4.4 ± 0.19 versus 4.6 ± 0.19; mean difference, -0.21; 95% CI -0.74 to 0.33; P = 0.445). Multivariate analysis, including only women receiving the intervention, showed that none of the confounding factors modified the response to estradiol.

CONCLUSIONS

These results demonstrate that preoperative locally applied estrogen does not ameliorate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse.

TWEETABLE ABSTRACT

Preoperative local estrogen does not ameliorate prolapse-associated symptoms in postmenopausal women with pelvic organ prolapse.

摘要

目的

评估与安慰剂治疗相比,绝经后女性在接受手术治疗前局部应用阴道雌激素是否会影响脱垂相关症状。

设计

随机、双盲、安慰剂对照、多中心研究。

地点

维也纳医科大学和图尔恩大学医院的泌尿科。

人群

有症状的盆腔器官脱垂且计划进行手术治疗的绝经后女性。

方法

女性在术前 6 周随机分配接受局部雌激素乳膏或安慰剂乳膏治疗。

主要观察指标

主要结局是手术前 6 周治疗后脱垂相关症状的差异,采用综合德国盆底问卷进行评估。次要结局包括其他盆底相关症状(膀胱、肠道或性功能)的差异。

结果

在随机分组的 120 名女性中,103 名(86%)女性完成了最终分析。治疗 6 周后,雌激素组和安慰剂组的脱垂域评分无差异(4.4±0.19 与 4.6±0.19;平均差异,-0.21;95%置信区间-0.74 至 0.33;P=0.445)。包括仅接受干预的女性在内的多变量分析显示,没有混杂因素改变雌二醇的反应。

结论

这些结果表明,术前局部应用雌激素不能改善有症状的盆腔器官脱垂绝经后女性的脱垂相关症状。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8bfc/9293194/b25dbb487e2c/BJO-128-2200-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8bfc/9293194/b25dbb487e2c/BJO-128-2200-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8bfc/9293194/b25dbb487e2c/BJO-128-2200-g001.jpg

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