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含炔雌醇/依托孕烯 3.47/11.00 毫克或 2.7/11.7 毫克的避孕阴道环对女性性功能和生活质量影响的比较随机研究。

Comparative randomized study on the sexual function and quality of life of women on contraceptive vaginal ring containing ethinylestradiol/etonogestrel 3.47/11.00mg or 2.7/11.7mg.

机构信息

Departemt of General Surgery and Medical Surgical Specialties, University of Catania-Italy Research Group for Sexology, Catania, Italy.

出版信息

Gynecol Endocrinol. 2019 Oct;35(10):899-903. doi: 10.1080/09513590.2019.1603290. Epub 2019 Apr 16.

Abstract

The objective of the study was to evaluate the sexual function and quality of life (QoL) of healthy women on a new contraceptive vaginal ring (CVR) containing ethinylestradiol (EE) 3.47 mg and etonogestrel (ENG) 11.00 mg (study group) manufactured with a new polymer composition compared to EE 2.7 mg/ENG11.7 mg CVR (control group). Fifty-eight women were randomly allocated to the study group and the control group. The Female Sexual Function Index (FSFI), the Female Sexual Distress Scale (FSDS) and the Short Form-36, were used to assess sexual function, sexual distress and QoL, respectively. The study included two follow-ups, at 90 days and at 180 days. The control group reported more adverse events, mainly breakthrough bleeding, than the study group. The sexual function scores in the women in the study group improved with respect to those of the control group both at the 1st (FSFI,  = .009; FSDS,  = .001) and at the 2 (FSFI,  = .001; FSDS,  = .002) follow-up. QoL of the study group improved at the 1 follow-up ( < .05) and 2 ( < .01) follow-up. The control group improved their QoL at the 2nd follow-up ( < .01). The more gradual EE release of the new polymer composition could justify the behavioral differences of the women of the two groups.

摘要

本研究的目的是评估一种新的含炔雌醇(EE)3.47 毫克和依托孕烯(ENG)11.00 毫克的避孕阴道环(CVR)(研究组)对健康女性的性功能和生活质量(QoL)的影响,与 EE 2.7 毫克/ENG11.7 毫克 CVR(对照组)相比,新聚合物组成制造。58 名女性被随机分配到研究组和对照组。使用女性性功能指数(FSFI)、女性性困扰量表(FSDS)和简短形式 36 分别评估性功能、性困扰和生活质量。该研究包括两次随访,分别在第 90 天和第 180 天进行。对照组报告的不良事件多于研究组,主要是突破性出血。与对照组相比,研究组女性的性功能评分在第 1 次(FSFI,= 0.009;FSDS,= 0.001)和第 2 次(FSFI,= 0.001;FSDS,= 0.002)随访时均有所改善。研究组的 QoL 在第 1 次随访时有所改善(< 0.05)和第 2 次随访时(< 0.01)。对照组在第 2 次随访时改善了 QoL(< 0.01)。新聚合物组成中 EE 的释放更为渐进,这可以解释两组女性行为上的差异。

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