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流产后立即放置左炔诺孕酮宫内节育系统与铜宫内节育器的出血模式差异:一项针对中国女性的多中心、前瞻性、观察性队列研究

Bleeding pattern difference between levonorgestrel intrauterine system and copper intrauterine devices inserted immediately post-abortion: a multicenter, prospective, observational cohort study in Chinese women.

作者信息

Chen Xiaoning, Li Qianxi, Wang Xiaoye, Chen Jing, Lv Wen, Shi Bin, Wang Hong, Luo Jianru, Li Jian

机构信息

a Family Planning Department , Jiangxi Maternal and Child Health hospital , Nanchang , China.

b Obstetrics & Gynecology Department , Liuzhou Maternal and Child Health-Care Hospital , Liuzhou , China.

出版信息

Curr Med Res Opin. 2018 May;34(5):873-880. doi: 10.1080/03007995.2017.1421919. Epub 2018 Feb 7.

DOI:10.1080/03007995.2017.1421919
PMID:29298525
Abstract

BACKGROUND

To describe the bleeding pattern (primary outcome), side effects, treatment satisfaction and 6 month continuity rates associated with the 52 mg levonorgestrel intrauterine system (LNG-IUS) and the copper intrauterine device (Cu-IUD) inserted immediately after abortion.

METHODS

This multicenter, prospective, observational cohort study enrolled healthy women (aged ≥18 years) inserted with LNG-IUS or Cu-IUD immediately after first-trimester surgical abortion and followed up to 6 months. Bleeding pattern was obtained through daily patient bleeding diaries.

RESULTS

From 2013 to 2014, we enrolled 512 women (LNG-IUS = 312 [median age: 32.0 years] and Cu-IUD = 200 [median age: 30.0 years]) from nine Chinese centers. LNG-IUS resulted in a significantly lower number of bleeding/spotting days in the second 90 day reference period compared with Cu-IUD (median 14.5 vs. 18.0 days, p < .0001). Amenorrhea rate (no bleeding/spotting day in the second 90 day reference period) and no menstrual bleeding rate (absence of bleeding days in the second 90 day reference period) were significantly higher in LNG-IUS compared to Cu-IUD (13.9% vs. 0% and 39.5% vs. 0%; p < .001 for all). No dysmenorrhea was higher at the last follow-up in LNG-IUS users than Cu-IUD users (81.2% vs. 76%; p = .0047). Both treatments had a high satisfaction rate among women at both the follow-up visits, and the majority of them continued with the treatment. The rates of adverse events (e.g. oligomenorrhea, amenorrhea) in the LNG-IUS and Cu-IUD groups were 77.2% and 44.5% (p < .0001), respectively.

CONCLUSION

LNG-IUS post-abortion shows better bleeding patterns, and reduced dysmenorrhea and bleeding amount, but with a similar safety profile compared with Cu-IUD. ClinicalTrials.gov identifier: NCT01958684.

摘要

背景

描述与流产后立即插入的52毫克左炔诺孕酮宫内节育系统(LNG-IUS)和铜宫内节育器(Cu-IUD)相关的出血模式(主要结局)、副作用、治疗满意度及6个月的持续使用率。

方法

这项多中心、前瞻性、观察性队列研究纳入了健康女性(年龄≥18岁),她们在孕早期人工流产后立即插入LNG-IUS或Cu-IUD,并随访6个月。通过患者每日出血日记获取出血模式。

结果

2013年至2014年,我们从中国9个中心招募了512名女性(LNG-IUS组=312名[中位年龄:32.0岁],Cu-IUD组=200名[中位年龄:30.0岁])。与Cu-IUD相比,LNG-IUS在第二个90天参考期内的出血/点滴出血天数显著更少(中位天数分别为14.5天和18.0天,p<0.0001)。LNG-IUS组的闭经率(第二个90天参考期内无出血/点滴出血天数)和无月经出血率(第二个90天参考期内无出血天数)显著高于Cu-IUD组(分别为13.9%对0%和39.5%对0%;所有p<0.001)。在最后一次随访时,LNG-IUS使用者中无痛经的比例高于Cu-IUD使用者(81.2%对76%;p=0.0047)。两种治疗在随访时女性的满意度都很高,且大多数女性继续接受治疗。LNG-IUS组和Cu-IUD组的不良事件发生率(如月经过少、闭经)分别为77.2%和44.5%(p<0.0001)。

结论

流产后使用LNG-IUS显示出更好的出血模式,痛经和出血量减少,但与Cu-IUD相比安全性相当。ClinicalTrials.gov标识符:NCT01958684。

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