Department of Obstetrics and Gynecology, Faculty of Medical Sciences, University of Campinas, Campinas, São Paolo, Brazil.
Department of Obstetrics and Gynecology, Faculty of Medical Sciences, University of Campinas, Campinas, São Paolo, Brazil.
Fertil Steril. 2018 Nov;110(6):1129-1136. doi: 10.1016/j.fertnstert.2018.07.003.
To assess the efficacy of an etonogestrel (ENG)-releasing contraceptive implant or the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) in the control of endometriosis-associated pelvic pain.
Noninferiority randomized clinical trial in which women with endometriosis were assigned to use an ENG implant (experimental treatment) or an LNG-IUS (active comparator). Monthly follow-up visits were conducted up to 6 months.
University teaching hospital.
PATIENT(S): One hundred three women, with endometriosis-associated chronic pelvic pain, dysmenorrhea, or both for more than 6 months. In cases of deep endometriosis, vaginal ultrasonography and magnetic resonance imaging were used as additional diagnostic tools.
INTERVENTION(S): The ENG implant or the LNG-IUS were inserted within the first 5 days of the menstrual cycle.
MAIN OUTCOME MEASURE(S): Daily scores of noncyclic pelvic pain and dysmenorrhea were evaluated using a daily visual analogue scale. Health-related quality of life was evaluated using the Endometriosis Health Profile-30 questionnaire at baseline and up to 6 months. Bleeding patterns were assessed daily from a menstrual calendar.
RESULT(S): Both contraceptives improved significantly the mean visual analogue scale endometriosis-associated pelvic pain and dysmenorrhea, without significant differences between treatment group profiles. Health-related quality of life improved significantly in all domains of the core and modular segments of the Endometriosis Health Profile-30 questionnaire, with no difference between both treatment groups. The most common bleeding patterns at 180 days of follow-up were amenorrhea and infrequent bleeding and infrequent bleeding and spotting among ENG implant and LNG-IUS users, respectively.
CONCLUSION(S): In this noninferiority study both contraceptives improved significantly pelvic pain, dysmenorrhea, and health-related quality of life in endometriosis.
Clinicaltrials.gov under number NCT02480647.
评估依托孕烯（ENG）释放型避孕埋植剂或 52mg 左炔诺孕酮释放宫内节育系统（LNG-IUS）治疗子宫内膜异位症相关盆腔痛的疗效。
非劣效性随机临床试验，将子宫内膜异位症患者分为使用 ENG 埋植剂（实验组）或 LNG-IUS（阳性对照）。每月随访 6 个月。
大学教学医院。
103 名患有子宫内膜异位症相关慢性盆腔痛、痛经或两者兼有且持续超过 6 个月的患者。对于深部子宫内膜异位症，阴道超声和磁共振成像被用作额外的诊断工具。
ENG 埋植剂或 LNG-IUS 在月经周期的前 5 天内插入。
采用每日视觉模拟评分法评估非周期性盆腔痛和痛经的每日评分。采用子宫内膜异位症健康状况问卷-30 评估健康相关生活质量，基线时和 6 个月时进行评估。使用月经日历每日评估出血模式。
两种避孕方法均显著改善了平均视觉模拟评分的子宫内膜异位症相关盆腔痛和痛经，且治疗组之间无显著差异。所有核心和模块部分的健康相关生活质量在子宫内膜异位症健康状况问卷-30 中均显著改善，两组治疗之间无差异。180 天随访时最常见的出血模式是闭经和不频繁出血以及 ENG 埋植剂和 LNG-IUS 使用者的不频繁出血和斑点出血。
在这项非劣效性研究中，两种避孕方法均显著改善了子宫内膜异位症患者的盆腔痛、痛经和健康相关生活质量。
Clinicaltrials.gov 注册号为 NCT02480647。
