Chen Xiaoning, Li Qianxi, Wang Xiaoye, Chen Jing, Lv Wen, Shi Bin, Wang Hong, Luo Jianru, Li Jian
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.
Curr Med Res Opin. 2018 May;34(5):873-880. doi: 10.1080/03007995.2017.1421919. Epub 2018 Feb 7.
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.
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.
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.
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.
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。
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。
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)。
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。