de Jonge Eric T, Yigit Refika, Molenberghs Geert, Straetmans Dany, Ombelet Willem
Department of Obstetrics and Gynecology, Ziekenhuis Oost-Limburg Campus Sint Jan, 3600 Genk, Belgium.
Contraception. 2007 Aug;76(2):91-5. doi: 10.1016/j.contraception.2007.04.003. Epub 2007 Jun 22.
The study was conducted to identify predictors of oligoamenorrhea at 12 months in levonorgestrel-releasing intrauterine system (LNG-IUS) users.
A 12-month observational study.
Gynecologic outpatient clinic in a large regional hospital in Flanders, Belgium.
A total of 150 women who had made an informed decision to use a LNG-IUS either as a method of contraception or to manage menorrhagia.
All women were premenopausal and first-time users. The variables recorded prior to insertion on Days 1 to 5 of the menstrual cycle were age, parity, body mass index, indication for LNG-IUS use, prior contraceptive use, menstrual bleeding history, length of the uterine cavity, endometrial thickness, number of antral follicles, serum follicle-stimulating hormone, inhibin B and anti-Müllerian hormone. Menstrual bleeding pattern, patient satisfaction or wish to discontinue the method was noted at 3, 6 and 12 months of follow-up visits.
Menstrual bleeding pattern (amenorrhea, oligomenorrhea, menorrhagia) at 12 months was taken as the primary outcome measurement. Patient satisfaction was followed as a secondary outcome.
Oligoamenorrhea was associated with a high patient satisfaction. A bleeding period less than 5 days, absence of severe uterine bleeding at baseline, LNG-IUS use for contraception and oligoamenorrhea at 3 months were predictors of a favorable outcome at 12 months in a univariate analysis. The absence of severe bleeding prior to LNG-IUS insertion was the only clinically useful predictor of favorable outcome in the multivariate analysis (odds ratio 0.13, 95% confidence interval 0.02-0.66).
Patient profiling as described is not helpful in counselling women for intentional LNG-IUS use, especially not if it is planned as a method of managing menorrhagia.
本研究旨在确定左炔诺孕酮宫内节育系统(LNG-IUS)使用者在12个月时出现月经过少的预测因素。
一项为期12个月的观察性研究。
比利时弗拉芒大区一家大型地区医院的妇科门诊。
共有150名女性,她们已做出明智决定,使用LNG-IUS作为避孕方法或治疗月经过多。
所有女性均为绝经前且首次使用者。在月经周期第1至5天插入前记录的变量包括年龄、产次、体重指数、使用LNG-IUS的指征、既往避孕方法使用情况、月经出血史、子宫腔长度、子宫内膜厚度、窦卵泡数量、血清促卵泡生成素、抑制素B和抗苗勒管激素。在随访的3、6和12个月时记录月经出血模式、患者满意度或停用该方法的意愿。
以12个月时的月经出血模式(闭经、月经过少、月经过多)作为主要观察指标。将患者满意度作为次要观察指标。
月经过少与患者高满意度相关。在单因素分析中,出血期少于5天、基线时无严重子宫出血、使用LNG-IUS避孕以及3个月时月经过少是12个月时预后良好的预测因素。在多因素分析中,LNG-IUS插入前无严重出血是唯一对预后良好有临床意义的预测因素(比值比0.13,95%置信区间0.02 - 0.66)。
所述的患者特征分析对指导女性有意使用LNG-IUS并无帮助,尤其是在计划将其作为治疗月经过多的方法时。