Cagnacci Angelo, Bastianelli Carlo, Neri Manuela, Cianci Antonio, Benedetto Chiara, Calanni Luana, Vignali Michele, De Leo Vincenzo, Cicinelli Ettore, Borrelli Giuseppe, Volpe Annibale
a Clinica Ginecologica e Ostetrica , Azienda Sanitaria Universitaria Integrata di Udine , Udine , Italy.
b Dipartimento di Scienze Ostetriche e Ginecologiche e Scienze Urologiche , La Sapienza Università di Roma , Rome , Italy.
Eur J Contracept Reprod Health Care. 2018 Dec;23(6):393-399. doi: 10.1080/13625187.2018.1541080. Epub 2018 Nov 22.
The aim of the study was to examine treatment continuation and satisfaction over 1 year among women receiving nomegestrol acetate (NOMAC)/oestradiol (E2) combined oral contraception (COC) in real-world clinical practice.
The 17β-Estradiol and Nomegestrol Acetate (BOLERO) Study is an observational, non-interventional, prospective, multicentre cohort study of premenopausal women (aged 18-50 years) who received prescription NOMAC/E2 (2.5 mg/1.5 mg) for contraception during routine clinical practice. Assessments were carried out at enrolment and at 3, 6 and 12 months. Probability of treatment continuation through 12 months (primary outcome) was examined using Kaplan-Meier survival analysis. Secondary outcomes included treatment satisfaction, menstrual cycle-related symptoms, libido and adverse events (AEs).
Of 298 enrolled women, 292 were evaluable. The probability of NOMAC/E2 continuation through 12 months was 73.7% (95% confidence interval [CI] 68.0%, 78.5%). Satisfaction with NOMAC/E2 increased from 56.9% (37/65) of women at initial evaluation to 89.2% (58/65) of women at 12 months. Physician ratings at 12 months showed satisfactory to very satisfactory in 84.0% (168/200) of women. Libido was not affected. Menstrual cycle-related symptoms significantly declined from enrolment (6.04 ± 4.32) to 3 months (3.25 ± 3.05) and 12 months (2.62 ± 2.74; p < .0001). Treatment-related AEs were reported by 38.7% (113/292) of women.
The real-world experience of women receiving NOMAC/E2 indicated very good treatment continuation, high satisfaction and significantly improved menstrual cycle-related symptoms.
本研究旨在调查在现实临床实践中接受醋酸诺美孕酮（NOMAC）/雌二醇（E2）复方口服避孕药（COC）的女性在1年期间的治疗持续情况和满意度。
17β-雌二醇和醋酸诺美孕酮（BOLERO）研究是一项观察性、非干预性、前瞻性、多中心队列研究，研究对象为绝经前女性（年龄18 - 50岁），她们在常规临床实践中接受了处方NOMAC/E2（2.5毫克/1.5毫克）用于避孕。在入组时以及3、6和12个月时进行评估。使用Kaplan-Meier生存分析来检验持续治疗12个月的概率（主要结局）。次要结局包括治疗满意度、月经周期相关症状、性欲和不良事件（AE）。
在298名入组女性中，292名可进行评估。NOMAC/E2持续治疗12个月的概率为73.7%（95%置信区间[CI] 68.0%，78.5%）。对NOMAC/E2的满意度从初始评估时的56.9%（37/65）的女性增加到12个月时的89.2%（58/65）的女性。12个月时医生的评分显示84.0%（168/200）的女性为满意至非常满意。性欲未受影响。月经周期相关症状从入组时（6.04±4.32）显著下降至3个月时（3.25±3.05）和12个月时（2.62±2.74；p <.0001）。38.7%（113/292）的女性报告了与治疗相关的不良事件。
接受NOMAC/E2的女性的现实临床经验表明治疗持续情况良好、满意度高且月经周期相关症状显著改善。
