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左炔诺孕酮宫内节育系统(LNG-IUS)连续使用的出血模式和安全性——一项多中心前瞻性研究。

Bleeding pattern and safety of consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS)--a multicentre prospective study.

机构信息

Department of Obstetrics and Gynaecology, Karolinska University Hospital, Stockholm, Sweden.

出版信息

Hum Reprod. 2010 Feb;25(2):354-9. doi: 10.1093/humrep/dep426. Epub 2009 Dec 1.

DOI:10.1093/humrep/dep426
PMID:19955104
Abstract

BACKGROUND

The LNG-IUS has increasingly been used for contraception, treatment of menorrhagia and endometrial protection during hormone replacement therapy since mid-1990s. Thus, many women use the LNG-IUS consecutively. However, published data on the bleeding pattern regarding consecutive use of the LNG-IUS is scarce.

METHODS

We performed a prospective 15-month multicentre study on the bleeding profile, removal and insertion procedures and safety of the second LNG-IUS in fertile-aged women who had used their first LNG-IUS between 4 years 3 months and 4 years 9 months and who opted for the insertion of a second IUS immediately after removal of the first IUS. Bleeding data were reported descriptively starting from the last 90 days of the first IUS use and continuing for up to 1 year.

RESULTS

Of the 234 subjects screened, 204 (87%) entered the trial. The median number of bleeding/spotting days during the last 90 days of the first LNG-IUS was 7 (25 and 75% percentiles 0 and 15). Due to bleeding associated with the insertion procedure, this increased to 8 days (4 and 18) during the first 90-day reference period, thereafter decreasing to 4 (0 and 10) days during the second to fourth reference periods. Only one expulsion and no pregnancies, pelvic inflammatory diseases or perforations occurred. A total of 12 subjects (5.9%) prematurely discontinued the study: five due to an adverse event and seven due to other reasons (inclusive of loss to follow-up).

CONCLUSIONS

This study confirms the favourable bleeding profile and safety of consecutive use of the LNG-IUS.

摘要

背景

自 20 世纪 90 年代中期以来,LNG-IUS 已越来越多地用于避孕、治疗月经过多和激素替代治疗期间的子宫内膜保护。因此,许多女性连续使用 LNG-IUS。然而,关于连续使用 LNG-IUS 的出血模式的发表数据很少。

方法

我们对 204 名年龄在 4 岁 3 个月至 4 岁 9 个月之间、在使用第一个 LNG-IUS 4 年 3 个月至 4 年 9 个月后选择立即插入第二个 IUS 的生育期妇女进行了前瞻性、为期 15 个月的多中心研究,以评估第二个 LNG-IUS 的出血模式、取出和插入程序以及安全性。从第一个 LNG-IUS 使用的最后 90 天开始,继续描述出血数据,直至 1 年。

结果

在 234 名筛选的受试者中,有 204 名(87%)进入了试验。第一个 LNG-IUS 使用的最后 90 天内的平均出血/点状出血天数为 7 天(25%和 75%百分位数为 0 和 15)。由于与插入程序相关的出血,在第一个 90 天的参考期内增加到 8 天(4%和 18%),此后在第二个至第四个参考期内减少到 4 天(0%和 10%)。仅发生 1 例脱落,无一例妊娠、盆腔炎或穿孔。共有 12 名受试者(5.9%)提前退出研究:5 名因不良事件,7 名因其他原因(包括失访)。

结论

本研究证实了连续使用 LNG-IUS 的良好出血模式和安全性。

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