口服醋酸诺美孕酮/雌二醇在门诊宫腔镜下息肉切除术前快速随机启动子宫内膜准备中的应用：一项多中心、前瞻性、随机对照试验。

The use of oral nomegestrol acetate/estradiol in rapid and random start preparation of endometrium before office hysteroscopic polypectomies: A multicenter, prospective, randomized controlled trial.

作者信息

Etrusco Andrea, Agrifoglio Vittorio, Chiantera Vito, D'Amato Antonio, Russo Giuseppe, Golia D'Augè Tullio, Giannini Andrea, Riemma Gaetano, Pecorino Basilio, Ferrari Federico, Laganà Antonio Simone, Monti Marco

机构信息

Unit of Obstetrics and Gynecology, "Paolo Giaccone" Hospital, 90127 Palermo, Italy; Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, 90133 Palermo, Italy.

Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, 90133 Palermo, Italy; Unit of Gynecologic Oncology, National Cancer Institute - IRCCS - Fondazione "G. Pascale", 80131 Naples, Italy.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2024 Aug;299:213-218. doi: 10.1016/j.ejogrb.2024.06.019. Epub 2024 Jun 10.

DOI:10.1016/j.ejogrb.2024.06.019

PMID:38897097

Abstract

OBJECTIVE

To evaluate the use of oral nomegestrol acetate/estradiol in random start rapid preparation of endometrium before office hysteroscopic polypectomy.

STUDY DESIGN

Multicenter, prospective, randomized controlled trial.

SETTING

University hospitals.

PARTICIPANTS

80 adult women undergoing office hysteroscopic polypectomy between January 2023 and March 2024 were randomized to intervention (n = 40) or control (n = 40). Exclusion criteria included the presence of endouterine pathology other than endometrial polyps solely.

METHODS

Subjects in the intervention group were treated with oral nomegestrol acetate/estradiol 1.5 mg/2.5 mg/day started taking the drug from an indefinite time in the menstrual cycle (random start) for 14 days. Subjects in the control group did not receive any pharmaceutical treatment and underwent polypectomy between days 8 and 11 of the menstrual cycle.

RESULTS

On the day of the procedure, the difference in pre- and post-office hysteroscopic polypectomy endometrial ultrasound thickness was statistically significant between the two groups, with endometrial thickness in both measurements being thinner for the intervention group (p < 0.001). In the nomegestrol acetate/estradiol-treated group, compared with the control, there was also a statistically significant difference in the physician's assessment of the quality of endometrial preparation (p < 0.001), the quality of visualization of the uterine cavity (p < 0.001), and satisfaction with the performance of the procedure (p < 0.001). Finally, all surgical outcomes analyzed were better in the treatment group.

CONCLUSION

Treatment with nomegestrol acetate/estradiol could provide rapid, satisfactory and low-cost preparation of the endometrium before office polypectomy, thus improving surgical performance and woman's compliance.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06316219.

摘要

目的

评估口服醋酸诺美孕酮/雌二醇在门诊宫腔镜息肉切除术前随机起始快速准备子宫内膜中的应用。

研究设计

多中心、前瞻性、随机对照试验。

研究地点

大学医院。

研究对象

2023年1月至2024年3月期间接受门诊宫腔镜息肉切除术的80名成年女性被随机分为干预组（n = 40）或对照组（n = 40）。排除标准包括仅存在子宫内膜息肉以外的子宫内病变。

方法

干预组受试者口服醋酸诺美孕酮/雌二醇1.5毫克/2.5毫克/天，从月经周期中的不确定时间开始服药（随机起始），持续14天。对照组受试者未接受任何药物治疗，在月经周期的第8至11天接受息肉切除术。

结果

在手术当天，两组门诊宫腔镜息肉切除术前、后子宫内膜超声厚度差异有统计学意义，干预组两次测量的子宫内膜厚度均较薄（p < 0.001）。在醋酸诺美孕酮/雌二醇治疗组中，与对照组相比，医生对子宫内膜准备质量的评估（p < 0.001）、子宫腔可视化质量（p < 0.001）以及对手术操作的满意度（p < 0.001）也有统计学意义的差异。最后，治疗组所有分析的手术结果均更好。