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经宫腔镜宫腔粘连分离术后应用透皮雌激素凝胶与口服雌激素的比较:一项前瞻性随机研究。

Transdermal estrogen gel vs oral estrogen after hysteroscopy for intrauterine adhesion separation: A prospective randomized study.

机构信息

Department of Gynecology and Obstetrics, West China Second University Hospital of Sichuan University, Chengdu, China.

Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China.

出版信息

Front Endocrinol (Lausanne). 2023 Mar 8;14:1066210. doi: 10.3389/fendo.2023.1066210. eCollection 2023.

Abstract

BACKGROUND

This randomized controlled trial (RCT) aimed to compare two different routes of postoperative estrogen treatment on the improvements of menstruation, postoperative endometrial thickness, and fertility outcomes in patients with moderate to severe intrauterine adhesions (IUA).

METHODS

This study prospectively included 78 women (age: 25 to 45 years) with moderate to severe IUA who underwent hysteroscopic resection of adhesions between March 2019 and October 2020. The enrolled patients were randomized 1:1 into either the transdermal gel group (n = 39) or the estradiol valerate oral tablet group (n = 39) on the day of receiving hysteroscopy. Postoperative endometrial thickness, AFS (American Fertility Society) score, estrogen level, and the pattern and amount of menstruation were compared. Pregnancy information was actively collected during 1-year follow-up after the operation.

RESULTS

The postoperative endometrium thickness was improved in both groups, and both groups gained menstruation improvement rates of 67%. For patients who underwent second-look hysteroscopy (17 from the oral group and 19 from the transdermal group), the mean AFS score declined greater than 2 in both groups. For patients with postoperative pregnancy intention, the pregnancy rates at 1-year follow-up after the procedures were 40.5% and 28% in the transdermal group and oral group, respectively. Although no statistically significant difference was observed between the two groups, patients in the transdermal group had a tendency toward increased pregnancy rate.

CONCLUSIONS

Transdermal administration of estrogen is equally efficacious as oral estrogen in postoperative treatment of IUA patients with a relatively safe profile. It is very likely to broaden its indication to the field of IUA.

TRIAL REGISTRATION

http://www.chictr.org.cn/showproj.aspx?proj=37197, identifier ChiCTR1900022110.

摘要

背景

本随机对照试验(RCT)旨在比较两种不同的术后雌激素治疗途径对中重度宫腔粘连(IUA)患者改善月经、术后子宫内膜厚度和生育结局的效果。

方法

本研究前瞻性纳入 2019 年 3 月至 2020 年 10 月接受宫腔镜粘连切除术的 78 例中重度 IUA 患者(年龄 25 至 45 岁)。患者在接受宫腔镜检查的当天按 1:1 随机分为经皮凝胶组(n = 39)或戊酸雌二醇口服片剂组(n = 39)。比较术后子宫内膜厚度、美国生育协会(AFS)评分、雌激素水平以及月经模式和量。在手术后 1 年的随访期间积极收集妊娠信息。

结果

两组患者的术后子宫内膜厚度均有所改善,两组的月经改善率均为 67%。对于接受二次宫腔镜检查的患者(口服组 17 例,经皮组 19 例),两组的平均 AFS 评分均下降超过 2 分。对于有术后妊娠意向的患者,术后 1 年的妊娠率分别为经皮组 40.5%和口服组 28%。尽管两组之间没有统计学上的显著差异,但经皮组的妊娠率有增加的趋势。

结论

经皮雌激素给药与口服雌激素在治疗 IUA 患者方面同样有效,且具有相对安全的特征。它很可能拓宽其在 IUA 领域的适应证。

试验注册

http://www.chictr.org.cn/showproj.aspx?proj=37197,标识符 ChiCTR1900022110。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/656c/10031037/3e2d638bb2ec/fendo-14-1066210-g001.jpg

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